code	text
6158	Authorities for increased maximum quantities and/or repeats for the oral forms of diazepam will be granted only for (i) the treatment of disabling spasticity; or(ii) malignant neoplasia (late stage); or(iii) use by patients who are receiving long-term nursing care on account of age, infirmity or other condition in hospitals, nursing homes or residential facilities and who have been demonstrated, within the past six months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal; or(iv) use by a patient who is receiving long-term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult and who has been demonstrated, within the past six months, to be benzodiazepine dependent by an unsuccessful attempt at gradual withdrawal. Up to six months' treatment (i.e. one month's treatment with five repeats) may be requested.
6523	For immunisation of adults and children aged greater than or equal to 8 years.
6671	Any queries concerning the arrangements to prescribe infliximab may be directed to the Veterans' Affairs Pharmaceutical Advisory Centre (VAPAC) on 1800 552 580. Written applications for authority to prescribe infliximab should be forwarded to: Reply Paid 9998 Veterans' Affairs Pharmaceutical Advisory Centre (VAPAC) Department of Veterans' Affairs GPO Box 9998 BRISBANE QLD 4001
6810	Continuing Therapy Only: For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner.  Further information can be found in the Explanatory Notes for Nurse Practitioners.
7604	Patients who have developed intolerance to sunitinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised pazopanib.
7605	Patients who have progressive disease with pazopanib are no longer eligible for PBS-subsidised pazopanib.
7606	No increase in the maximum quantity or number of units may be authorised.
7607	No increase in the maximum number of repeats may be authorised.
7608	Special Pricing Arrangements apply.
7614	Response Evaluation Criteria In Solid Tumours (RECIST) is defined as follows:Complete response (CR) is disappearance of all target lesions.Partial response (PR) is a 30% decrease in the sum of the longest diameter of target lesions.Progressive disease (PD) is a 20% increase in the sum of the longest diameter of target lesions.Stable disease (SD) is small changes that do not meet above criteria.
7620	Patients who have developed intolerance to pazopanib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib.
7621	Patients who have progressive disease with sunitinib are no longer eligible for PBS-subsidised sunitinib.
7703	Continuing Therapy Only:For prescribing by nurse practitioners as continuing therapy only, where the treatment of, and prescribing of medicine for, a patient has been initiated by a medical practitioner. Further information can be found in the Explanatory Notes for Nurse Practitioners. 
7708	One injection of hydroxocobalamin 1 mg every three months provides appropriate maintenance therapy in vitamin B12 deficiencies.
7709	Pharmaceutical benefits that have the form hydroxocobalamin injection 1 mg (as acetate) in 1 mL and pharmaceutical benefits that have the form hydroxocobalamin injection 1 mg (as chloride) in 1 mL are equivalent for the purposes of substitution.
7740	Up to a maximum of 18 pens will be reimbursed through the PBS. 
7753	Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.auApplications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hposOr mailed to:Services AustraliaComplex DrugsReply Paid 9826HOBART TAS 7001
7767	Authority applications for continuing treatment may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
7775	Management includes initiation, stabilisation and review of therapy as required.
7813	Pharmaceutical benefits that have the forms omeprazole tablet 20 mg, omeprazole capsule 20 mg and omeprazole tablet 20 mg (as magnesium) are equivalent for the purposes of substitution.
7850	Molnlycke Health Care products are distributed through leading pharmacy distributors. To best ensure product availability at the RPBS agreed prices, special arrangements have been made with API and Independence Australia Health Solutions (IAHS). IAHS orders can be placed on: Tel: 1300 788 855; or Email: customerservice@independenceaustralia.com. Molnlycke Health Care is not able to ensure product availability or pricing on listed products beyond these two suppliers.
7873	The in-use shelf life of Hylo-Fresh and Hylo-Forte is 6 months from the date of opening. 
7901	Shared Care Model:For prescribing by nurse practitioners where care of a patient is shared between a nurse practitioner and medical practitioner in a formalised arrangement with an agreed management plan. Further information can be found in the Explanatory Notes for Nurse Practitioners.
8019	The in-use shelf life of VitA-POS is 6 months from the date of opening.
8030	Fosamax Plus provides a supplemental intake of vitamin D. The amount of colecalciferol present in Fosamax Plus is not sufficient to use as the sole treatment for correction of vitamin D deficiency.
8176	Pharmaceutical benefits that have the forms clopidogrel tablet 75 mg (as besilate) and clopidogrel tablet 75 mg (as hydrogen sulfate) are equivalent for the purposes of substitution.
8221	For immunisation of adults and children aged greater than or equal to 8 years.
8295	Pharmaceutical benefits that have the form perindopril with indapamide hemihydrate tablet (containing 4 mg perindopril erbumine-1.25 mg indapamide hemihydrate) and pharmaceutical benefits that have the form perindopril with indapamide hemihydrate tablet (containing 5 mg perindopril arginine-1.25 mg indapamide hemihydrate) are equivalent for the purposes of substitution.
8312	Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for hepatitis C:(a) a nurse educator/counsellor for patients; and(b) 24-hour access by patients to medical advice; and(c) an established liver clinic.
8480	Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.
8541	Smith & Nephew products are distributed via the three major wholesalers, API, Sigma and Symbion. To best ensure product availability at RPBS agreed prices, please order from one of these suppliers. In the event that your preferred wholesaler cannot supply, please contact Smith & Nephew Customer Service on 13 13 60. Smith & Nephew cannot ensure RPBS agreed pricing from distributors other than those aforementioned.
8559	Helicobacter pylori eradication therapy should be considered prior to commencing initial treatment of peptic ulcer with this drug.
8579	Used as an adjunct in the management of leg ulceration and associated eczema and skin conditions.
8580	Treatment of varices and oedema associated with venous disease and lymphoedema; contraindicated in arterial disease.
8582	Sorafenib is not PBS-subsidised for adjunctive treatment after resection, ablation or chemoembolization.Sorafenib is not PBS-subsidised for maintenance therapy after disease progression.
8590	The patient or carer must be able to understand and administer the imiquimod dosing regimen.
8591	Treatment of recurrent (previously treated) lesions will not be authorised.
8592	Pharmaceutical benefits that have the form imiquimod single use sachets and pharmaceutical benefits that have the form imiquimod multi-use pump are equivalent for the purposes of substitution.
8683	For patients who commence therapy with ipilimumab:(i) Decisions concerning efficacy should await completion of the entire induction regimen (four doses) and should be made in conjunction with established criteria for immunological responses. However induction may be ceased or delayed if symptomatic progressive disease or intolerable adverse events occur and if, in the opinion of the clinician, continuation of treatment poses a risk to the patient;(ii) Tumour responses may occur beyond the initial 12 week induction phase and evaluation for potential later responses should be undertaken regularly for the first year. 
8695	A patient may only qualify for PBS-subsidised treatment under this restriction once.
8730	Authorities for increased maximum quantities, up to a maximum of 48, may be authorised.
8757	For first continuing supply, applications for increased repeats for up to 3 months' supply may be authorised.
8758	Where consultation with a palliative care specialist or service has occurred, applications for increased repeats for up to 3 months' supply may be authorised.
8759	Telephone approvals are limited to 1 months' therapy.
9086	The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.
9162	It is highly desirable that all patients be included in the national cystic fibrosis patient database.
9221	Pharmaceutical benefits that have the form olanzapine tablet 5 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 5 mg are equivalent for the purposes of substitution.
9222	Pharmaceutical benefits that have the form olanzapine tablet 10 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 10 mg are equivalent for the purposes of substitution.
9223	Pharmaceutical benefits that have the form olanzapine tablet 15 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 15 mg are equivalent for the purposes of substitution.
9224	Pharmaceutical benefits that have the form olanzapine tablet 20 mg (orally disintegrating) and pharmaceutical benefits that have the form olanzapine wafer 20 mg are equivalent for the purposes of substitution.
9251	A patient who has had progressive disease when treated with another BRAF inhibitor is not eligible to receive PBS-subsidised treatment with this drug.
9258	A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
9293	Only 2 courses of PBS-subsidised nicotine replacement therapy may be prescribed per 12-month period.Benefit is improved if used in conjunction with a comprehensive support and counselling program.
9314	This fixed dose combination tablet is not PBS-subsidised for use in combination with a sulfonylurea (triple oral therapy), as initial therapy or in combination with a thiazolidinedione (glitazone), a glucagon-like peptide-1 or an SGLT2 inhibitor. 
9371	Alogliptin is not PBS-subsidised for use in combination with metformin and a sulfonylurea (triple oral therapy), as monotherapy or in combination with a thiazolidinedione (glitazone), a glucagon-like peptide-1 or an SGLT2 inhibitor.
9426	Authorities for increased maximum quantities, up to a maximum of 20, may be authorised. 
9541	Flutiform is not recommended nor PBS-subsidised for use as 'maintenance and reliever' therapy.
9542	Flutiform is not indicated or PBS-subsidised for bronchodilator therapy in COPD. 
9552	Pharmaceutical benefits that have the form esomeprazole tablet 20 mg and pharmaceutical benefits that have the form esomeprazole capsule 20 mg are equivalent for the purposes of substitution. 
9774	Authorities for increased maximum quantities, up to a maximum of 52, may be authorised.
9785	Pharmaceutical benefits that have the form esomeprazole tablet 40 mg and pharmaceutical benefits that have the form esomeprazole capsule 40 mg are equivalent for the purposes of substitution.
9789	No applications for increased maximum quantities and/or repeats will be authorised for the tablets containing 320 mg valsartan.
9886	This drug is not PBS-subsidised for use as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor (gliptin), a glucagon-like peptide-1 or an SGLT2 inhibitor. 
9915	Unlike Symbicort Turbuhaler 200/6, Symbicort Rapihaler 200/6 is not recommended nor PBS-subsidised for use as 'maintenance and reliever' therapy as the approved Product Information does not specify such use.
9919	Symbicort 400/12 is not recommended nor PBS-subsidised for use as 'maintenance and reliever' therapy.
9956	Arginine with carbohydrate is not indicated for the treatment of arginase deficiency and other inborn errors of protein metabolism. 
9977	Pharmaceutical benefits that have the forms doxycycline tablet 100 mg (as hyclate (hydrochloride)), doxycycline tablet 100 mg (as monohydrate) and doxycycline modified release capsule 100 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.
9992	Applications for increased maximum quantities will only be authorised for patients with body weight greater than 100 kg. 
9997	Pharmaceutical benefits that have the forms doxycycline tablet 50 mg (as hyclate (hydrochloride)), doxycycline tablet 50 mg (as monohydrate) and doxycycline modified release capsule 50 mg (as hyclate (hydrochloride)) are equivalent for the purposes of substitution.
10190	Temozolomide is not PBS-subsidised for use in conjunction with PBS-subsidised carmustine.
10231	A course of treatment with this drug is 12 weeks or up to 24 weeks, if initial treatment of 12 weeks has been successful.
10232	The period between commencing varenicline and bupropion or a new course of varenicline must be at least 6 months. 
10333	Denosumab is not PBS-subsidised for use in patients who have undergone curative surgical resection.
10370	In first-line usage, effectiveness and tolerance may be improved when irinotecan is combined with an infusional 5-fluorouracil regimen. 
10411	This product is not PBS-subsidised for the treatment of asthma.
10412	This product is not indicated for the initiation of bronchodilator therapy in COPD. 
10422	Use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply. 
10446	Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.
10499	The Department of Human Services website (www.humanservices.gov.au) has details of the toxicities, including severity, which will be accepted for the following purposes:(a) exempting a patient from the requirement to undertake a minimum 3 month trial of methotrexate at a 20 mg weekly dose; (b) substituting azathioprine, cyclosporin or sodium aurothiomalate for another DMARD as part of the 6 month intensive DMARD trial;(c) exempting a patient from the requirement for a 6 month trial of intensive DMARD therapy. 
10600	Authorities for increased maximum quantities, up to a maximum of 11, may be authorised.
10614	This drug is not recommended nor PBS-subsidised for use as 'maintenance and reliever' therapy.
10615	This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).
10664	Patients who have progressive disease with everolimus are no longer eligible for PBS-subsidised everolimus.
10728	Pharmaceutical benefits that have the form sumatriptan tablet 50 mg (as succinate) and pharmaceutical benefits that have the form sumatriptan tablet (fast disintegrating) 50 mg (as succinate) are equivalent for the purposes of substitution.
10798	This drug is not PBS-subsidised for first line treatment of typical scabies.
10872	Neurologists prescribing PBS-subsidised alemtuzumab must be registered with the Lemtrada monitoring program.
10909	OxyContin modified release tablets are intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse.
11039	Applications for authorisation under this criterion may be made by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).Written applications for authorisation under this criterion should be forwarded to:Department of Human ServicesComplex DrugsReply Paid 9826HOBART TAS 7001
11164	Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Department of Human Services website at www.humanservices.gov.au
11165	For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Department of Human Services website at www.humanservices.gov.au
11241	A patient may only qualify for PBS-subsidised treatment under this treatment phase restriction once during a short-term course of treatment.
11260	A patient who has progressive disease with eribulin is no longer eligible for PBS-subsidised eribulin.
11407	FruitiVits must only be used under strict supervision of a dietitian and a paediatrician.
11429	A LAMA includes tiotropium, glycopyrronium, aclidinium or umeclidinium.
11468	Not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet. 
11472	Not for use as neoadjuvant or adjuvant therapy.
11519	For patients with graft versus host disease, acute myeloid leukaemia or myelodysplastic syndrome, applications for an increased maximum quantity to allow for up to 1 month's treatment and repeats sufficient for up to 6 months' treatment may be authorised. 
11520	For patients undergoing allogeneic haematopoietic stem cell transplant, applications for an increased maximum quantity to allow for up to 1 month's treatment and repeats sufficient for up to 2 months' treatment may be authorised.
11532	A patient may only qualify for PBS-subsidised treatment under this restriction once in a lifetime.
11563	One capsule of itraconazole 50 mg (Lozanoc) is therapeutically equivalent to one 100 mg capsule of conventional itraconazole (Sporanox). The recommended dose of Lozanoc is therefore half the recommended dose for Sporanox. Lozanoc 50 mg capsules and Sporanox 100 mg capsules are not interchangeable.
11595	Application for an increased maximum quantity to allow for up to 1 month's treatment and repeats sufficient for up to 6 months' treatment may be authorised.
11808	A raise in LDH alone is not a sufficient reason to re-commence eculizumab, but thrombocytopenia with one marker of haemolysis (such as raised LDH, presence of schistocytes, or low/absence of haptoglobin) is an accepted reason to consider re-commencement of eculizumab treatment.
11809	Kidney transplantation/dialysis is not a contraindication to recommencement of eculizumab treatment.
11975	Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at www.humanservices.gov.au Written applications for authority to prescribe must be submitted to Department of Human Services. Human Services will then contact the prescriber by telephone.
12189	A maximum lifetime supply for this indication is limited to a maximum of 8 treatments per site and to 10 treatments per site for patients in whom radiotherapy is interrupted.
12230	Not for the treatment of Crohn disease
12335	This drug is not PBS-subsidised for primary prevention of breast cancer.
12336	This drug is not PBS-subsidised for adjuvant hormonal treatment of early breast cancer extended beyond 5 years, i.e. a patient who has received 2 years of tamoxifen therapy may only receive 3 years of PBS-subsidised treatment with exemestane.
12347	Only 1 course of not more than 6 months' therapy will be authorised.
12369	This drug is not PBS-subsidised for adjuvant hormonal treatment of early breast cancer where the total duration of this drug (or any other aromatase inhibitor) treatment extends beyond 5 years.
12375	Pharmaceutical benefits that have the form ranibizumab 0.165 mL injection syringe and pharmaceutical benefits that have the form ranibizumab 0.23 mL injection vial are equivalent for the purposes of substitution.
12539	For item codes 8649F and 1836P, pharmaceutical benefits that have the form capsule 250 mg are equivalent for the purposes of substitution.
12819	Pharmaceutical benefits that have the forms desvenlafaxine tablet (modified release) 50 mg, desvenlafaxine tablet (modified release) 50 mg (as benzoate) and desvenlafaxine tablet (extended release) 50 mg (as succinate) are equivalent for the purposes of substitution.
12820	Pharmaceutical benefits that have the forms desvenlafaxine tablet (modified release) 100 mg, desvenlafaxine tablet (modified release) 100 mg (as benzoate) and desvenlafaxine tablet (extended release) 100 mg (as succinate) are equivalent for the purposes of substitution.
12837	This drug is not PBS-subsidised for use as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone) or an SGLT2 inhibitor.
12869	Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 3 months treatment with methotrexate and 3 months treatment with sulfasalazine or leflunomide can be found on the Department of Human Services website (www.humanservices.gov.au)
12870	The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment and submitted to the Department of Human Services no later than 4 weeks from the cessation of the treatment course. If the response assessment is not submitted within these timeframes, the patient will be deemed to have failed this course of treatment.
12912	This medicine is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.
13021	For item codes 8869T and 1846E, pharmaceutical benefits that have the form tablet 0.5 mg are equivalent for the purposes of substitution.
13056	For items 8787L and 1842Y, pharmaceutical benefits that have the form tablet 0.5 mg are equivalent for the purposes of substitution.
13087	Carmustine is not PBS-subsidised for use in conjunction with PBS-subsidised temozolomide.
13096	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of temazepam. 
13099	Care must be taken to comply with the provisions of State/Territory law when prescribing this drug.
13108	The use of this drug for the treatment of the following conditions is not subsidised through the PBS:(a) acute pain;(b) soft tissue injury;(c) arthrosis without an inflammatory component.
13202	"Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.
13203	Aciclovir 200 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.
13205	For item codes 1003T and 1555W, pharmaceutical benefits that have the form tablet 200 mg are equivalent for the purposes of substitution.
13267	This drug is only effective if commenced within 72 hours of onset of rash.
13269	Aciclovir 800 mg is not PBS-subsidised for herpes simplex or chickenpox.
13287	No applications for repeats will be authorised.
13290	No applications for increased repeats will be authorised. 
13395	Not for use in the treatment of sclerosing cholangitis or cholelithiasis.
13413	Pharmaceutical benefits that have the form lansoprazole capsule 30 mg and pharmaceutical benefits that have the form lansoprazole tablet 30 mg (orally disintegrating) are equivalent for the purposes of substitution.
13420	Metronidazole has similar efficacy to vancomycin but may have less selective pressure to vancomycin resistant enterococci and is therefore the preferred treatment.
13428	This drug has been reported to cause frequent and potentially serious toxicity.
13429	Regular monitoring of hepatic and thyroid function is recommended.
13555	This drug is not PBS-subsidised for conditions other than CAPS.
13564	This drug should not be used as the first line of treatment.
13565	Other PBS-listed benzodiazepines should have been adequately tried and found to be ineffective or inappropriate.
13566	Authorities for increased quantities and/or repeats may be granted to patients with terminal disease, and other patients who have been shown to be dependent on this item by an unsuccessful attempt at gradual withdrawal.
13615	No applications for increased maximum quantities will be authorised.
13798	No applications for increased maximum quantities and/or repeats will be authorised for the 120 mg powder for injection.
13804	For item codes 2110C and 1880Y, pharmaceutical benefits that have the form tablet 20 mg (base) are equivalent for the purposes of substitution.
13808	Prescribing of drugs of addiction by dentists is not permitted in some States/Territories.
13839	Icatibant should be provided in the framework of a comprehensive hereditary angioedema prophylaxis program and an emergency Action Plan including training in recognition of the symptoms of hereditary angioedema and the self-administration of icatibant. (For further information see the Australasian Society of Clinical Immunology and Allergy website at www.allergy.org.au)
13902	Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.humanservices.gov.au or www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient's medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).
13915	Telephone approvals are limited to 1 month's therapy.
13916	Regular monitoring of drug serum levels is recommended.
13975	For copies of the ACQ please contact Novartis Medical Information on 1800 671 203 or medinfo.phauno@novartis.com
13976	It is recommended that an application for continuing treatment is submitted at the time of the 22 to 26 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised omalizumab treatment.
13978	Fentanyl transdermal patches are not recommended in opioid naive patients with non-cancer pain because of a high incidence of adverse events in these patients. Patients with cancer pain may be initiated on the lowest strength patch (12 micrograms per hour).
13979	Pharmaceutical benefits that have the form fentanyl 12 microgram/hour patch are equivalent for the purposes of substitution.
13980	Pharmaceutical benefits that have the form fentanyl 25 microgram/hour patch are equivalent for the purposes of substitution.
13981	Pharmaceutical benefits that have the form fentanyl 50 microgram/hour patch are equivalent for the purposes of substitution.
13983	Pharmaceutical benefits that have the form fentanyl 75 microgram/hour patch are equivalent for the purposes of substitution.
13984	Pharmaceutical benefits that have the form fentanyl 100 microgram/hour patch are equivalent for the purposes of substitution.
14062	The auto-injector should be provided in the framework of a comprehensive anaphylaxis prevention program and an emergency action plan including training in recognition of the symptoms of anaphylaxis and the use of the auto-injector device. (For further information see the Australasian Society of Clinical Immunology and Allergy website at www.allergy.org.au.)
14074	It is recommended that an application for continuing treatment is submitted at the time of the 18 to 22 week assessment, to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised omalizumab treatment.
14169	The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.
14187	Paediatric Seravit must only be used under strict supervision of a dietitian and a paediatrician.
14215	Authority applications may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
14216	Maintenance treatment is limited to one re-treatment (maximum 2 vials) every 2 years.
14252	Pharmaceutical benefits that have the form meloxicam tablet 7.5 mg and pharmaceutical benefits that have the form meloxicam capsule 7.5 mg are equivalent for the purposes of substitution.
14273	Pharmaceutical benefits that have the form meloxicam tablet 15 mg and pharmaceutical benefits that have the form meloxicam capsule 15 mg are equivalent for the purposes of substitution.
14291	Naproxen sodium 550 mg is approximately equivalent to 500 mg of naproxen acid.
14292	This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.
14337	Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS subsidised imatinib after progression on this drug
14355	This drug is not PBS-subsidised when chemotherapy partners are switched whilst maintaining an anti-EGFR antibody backbone in the face of progressive disease.
14358	The treatment must not exceed a single course of therapy with this drug for metastatic colorectal cancer in a patient's lifetime.
14359	The risk of serious muscle toxicity is increased if this drug is used concomitantly with HMG CoA reductase inhibitors or other fibrates. Such combination therapy should be used with caution in patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease and patients monitored closely for chronic signs of muscle toxicity.
14367	The patient should be ideally enrolled in an exercise program and be receiving supplemental vitamins.
14409	Changes in vitamin D levels and amino acid composition have occurred with a recent formulation change.
14458	In the first few months after start of immunotherapy, some patients can have a transient tumour flare with subsequent disease response. When progression is suspected, this should be confirmed through a confirmatory scan, taken at least 4 weeks later.
14514	Maximum quantity of four tubes (original + 3 repeats) in 12 months.
14522	Coloplast dressings are available via a range of distributors. However, Coloplast's principal agreement to ensure correct RPBS Price to Pharmacy and ready supply has been secured with Independence Australia on 1300 788 855 and BrightSky on 1300 290 400. Please note that Coloplast is unable to guarantee ready supply or rebate for price differences on purchases outside these distributors.
14526	Hartmann wound dressings are available through HARTMANN and Independence Australia only. If you would like to order Hartmann Wound Care products, please call HARTMANN customer service on 1800 805 839 or Independence Australia on 1300 788 855.
14559	Except in cases of hypopituitarism or primary amenorrhoea, the patient should have been adequately treated with clomifene citrate and/or gonadorelin and failed to have conceived.
14560	Women who have had apparent ovulation induced by other agents and have failed to conceive should have laparoscopic evidence that there is no other impediment to conception. 
14561	Oligomenorrhoea should have been present for at least twelve months or amenorrhoea for at least six months prior to treatment.
14562	Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.
14641	Authorities for increased maximum quantities and/or repeats will be granted only for:(i) chronic severe disabling pain associated with proven malignant neoplasia; or(ii) chronic severe disabling pain where treatment has been initiated by a specialist with appropriate expertise in pain management.
14656	Not to be used in preference to enuresis alarms.
14658	Only one application per six months with no more than twice the maximum quantity will be authorised for the tablets.
14663	Only one application per six months will be authorised for the wafers. No more than twice the maximum quantity for the 120 micrograms wafers and no applications for increased maximum quantities for the 240 micrograms wafers will be authorised.
14678	This drug is not PBS-subsidised for prophylaxis of malaria.
14698	Famciclovir 250 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.
14699	Famciclovir 125 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.
14700	Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.
14714	Famciclovir 500 mg is not PBS-subsidised for chickenpox.
14717	Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.
14726	Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). 
14781	Panitimumab is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody. 
14807	 For prescribing in accordance with Optometry Board of Australia guidelines.
14857	Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.
14883	This drug is not PBS-subsidised for Restless Legs Syndrome secondary to other causes
14981	This drug is not PBS-subsidised for the treatment of asthma.
15076	This drug is not PBS-subsidised for use in a child aged 2 to 5 years with moderate to severe asthma. It is not intended as an alternative for a child aged 2 to 5 years who requires a corticosteroid as a preventer medication.
15091	This drug is not PBS-subsidised for use in a patient aged 15 years or older, or for use in addition to a long-acting beta-agonist in any age group, or for use as a single second line preventer, as an alternative to corticosteroids, in a child aged 6 to 14 years with moderate to severe asthma.
15124	The period between commencing a course of bupropion hydrochloride and varenicline tartrate must be at least 6 months. 
15287	PBS-subsidised entecavir monohydrate must be used as monotherapy.
15317	Bandage can be left in situ for up to 7 days as per manufacturer's instructions.
15328	Buprenorphine with naloxone soluble film and buprenorphine with naloxone sublingual tablet do not meet all the criteria for bioequivalence. Patients being switched between sublingual tablets and soluble films may therefore require a dosage adjustment.
15332	Studies have shown that successful therapy with this drug is enhanced by patient participation in a support and counselling program.
15440	This product contains higher vitamin A levels than other PBS-listed glycomacropeptide products.
15537	Patients receiving thalidomide under the PBS listing must be registered in the i-access risk management program.
15549	Pharmaceutical benefits that have the form ondansetron tablet (orally disintegrating) 4 mg and pharmaceutical benefits that have the form ondansetron 4 mg wafer are equivalent for the purposes of substitution.
15550	Pharmaceutical benefits that have the form ondansetron tablet (orally disintegrating) 8 mg and pharmaceutical benefits that have the form ondansetron 8 mg wafer are equivalent for the purposes of substitution.
15568	This drug is not PBS-subsidised for administration with oral 5-HT3 antagonists.
15626	Pharmaceutical benefits that have the form fludarabine phosphate 50 mg injection and pharmaceutical benefits that have the form fludarabine phosphate 50 mg/2 mL injection are equivalent for the purposes of substitution.
15680	Eltrombopag is not PBS-subsidised as an alternative to splenectomy.
15983	Pharmaceutical benefits that have the form perindopril erbumine 8 mg tablet and pharmaceutical benefits that have the form perindopril arginine 10 mg tablet are equivalent for the purposes of substitution.
15984	Pharmaceutical benefits that have the form perindopril erbumine 2 mg tablet and pharmaceutical benefits that have the form perindopril arginine 2.5 mg tablet are equivalent for the purposes of substitution.
15985	Pharmaceutical benefits that have the form perindopril erbumine 4 mg tablet and pharmaceutical benefits that have the form perindopril arginine 5 mg tablet are equivalent for the purposes of substitution.
15986	Pharmaceutical benefits that have the form ramipril 1.25 mg tablet and pharmaceutical benefits that have the form ramipril 1.25 mg capsule are equivalent for the purposes of substitution.
15987	Pharmaceutical benefits that have the form ramipril 10 mg tablet and pharmaceutical benefits that have the form ramipril 10 mg capsule are equivalent for the purposes of substitution.
15988	Pharmaceutical benefits that have the form ramipril 2.5 mg tablet and pharmaceutical benefits that have the form ramipril 2.5 mg capsule are equivalent for the purposes of substitution.
15989	Pharmaceutical benefits that have the form ramipril 5 mg tablet and pharmaceutical benefits that have the form ramipril 5 mg capsule are equivalent for the purposes of substitution.
16368	If a patient receiving treatment under the indication short stature due to chronic renal insufficiency undergoes a renal transplant and 12 months post-transplant has an eGFR of equal to or greater than 30mL/min/1.73m2 prescribers should seek reclassification to the indication short stature and slow growth.
16411	This drug is not PBS-subsidised for use as monotherapy or in combination with a thiazolidinedione (glitazone), a glucagon-like peptide-1 or an SGLT2 inhibitor. 
16513	If recommencement of treatment is sought under a different indication than that under which the patient was previously receiving treatment an application for recommencement of treatment as a reclassified patient should be submitted.
16639	The 5 mg strength tablet should be used in malabsorption states only.
16645	Romiplostim is not PBS-subsidised as an alternative to splenectomy.
16668	For item codes 2414C and 1810G, pharmaceutical benefits that have the form tablet 20 mg are equivalent for the purposes of substitution.
16678	The spray should not be inhaled.
16679	No applications for increased maximum quantities and/or repeats will be authorised for the 320 mg tablet.
16725	For item codes 9501C and 1839T, pharmaceutical benefits that have the form capsule 250 mg are equivalent for the purposes of substitution
16728	The dose should be adjusted in accordance with renal function.
16731	Estradiol should be used in conjunction with an oral progestogen in women with an intact uterus.
16739	For item codes 2395C and 1818Q, pharmaceutical benefits that have the form injection 50 mg in 2 mL are equivalent for the purposes of substitution.
16747	Pharmaceutical benefits that have the form methylprednisolone powder for injection 40 mg (as sodium succinate) and pharmaceutical benefits that have the form methylprednisolone powder for injection 40 mg (as sodium succinate) with diluent are equivalent for the purposes of substitution.
16767	As prochlorperazine may be associated with parkinsonism and tardive dyskinesia it should be used for short-term treatment only. However, authorities for increased maximum quantities and/or repeats of prochlorperazine tablets will be granted for the treatment of emesis associated with malignant disease.
16860	The enteric coated preparations are for patients with a significant risk of gastrointestinal bleeding.
16861	Application to large areas of skin for longer than four weeks is not recommended.
16862	For patients who have failed to respond to simple moisturising agents.
16863	To be used in conjunction with the scalp cleanser salicylic acid with coal tar solution and pine tar (code 4447C).
16864	Smith & Nephew products are distributed via the three major wholesalers, API, Sigma & Symbion. To best ensure product availability at RPBS agreed prices, please order from one of these suppliers. In the event that your preferred wholesaler cannot supply, please contact Smith & Nephew Customer Service on 13 13 60. Smith & Nephew cannot ensure RPBS pricing from distributors other than those aforementioned.
16866	Suitable for yellow sloughy infected and malodorous wounds.
16867	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of nitrazepam.
16868	This dressing should be used only on moderately to heavily exuding wounds and should remain in place until saturated or for a maximum of 3 days.
16869	Paper wasp venom is not European wasp venom
16870	This dressing should remain in place until saturated or up to a maximum of 7 days. Allow a minimum of 2 cm to 3 cm in excess of the wound size of the dressing around the wound.
16871	Molnlycke Healthcare products are distributed through leading pharmacy distributors. To best ensure product availability at RPBS agreed prices, special arrangements have been made with API and Independence Australia Health Solutions (IAHS). IAHS orders can be placed on: Tel: 1300 788 855; or Email customerservice@independenceaustralia.com. Molnlycke Healthcare are not able to ensure product availability or pricing on listed products beyond these two suppliers.
16872	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of oxazepam.
16873	This dressing should remain in place until saturated or strike through occurs for a maximum of 7 days.
16874	This dressing should be applied to a thickness of 3 mm to 5 mm. It should be covered with a hydrocolloid dressing and may be left in place for up to 7 days.
16877	This dressing should be applied to a thickness of 3 mm to 5 mm and remain in situ in infected wounds for 24 hours and in clean wounds for up to 3 days. It should be covered with a secondary dressing such as foam or film. It should not be covered with gauze or combine.
17001	Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at www.humanservices.gov.auApplications for authority to prescribe should be forwarded to: Department of Human ServicesComplex DrugsReply Paid 9826 HOBART TAS 7001
17098	Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a 'Grandfathered' patient must qualify under the 'Continuing treatment' criteria. 
17287	This fixed dose combination tablet is not PBS-subsidised for use as initial therapy or in combination with a thiazolidinedione (glitazone), a glucagon-like peptide-1 or an SGLT2 inhibitor
17706	A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination. 
17712	Cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re-evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re-initiate PBS-subsidised omalizumab as a new patient.
17748	Clinical review is recommended within 2 to 3 weeks of the original prescription being requested.
17898	Pharmaceutical benefits that have the form zoledronic acid 4 mg/100 mL injection and pharmaceutical benefits that have the form zoledronic acid 4 mg/5 mL injection are equivalent for the purposes of substitution.
17936	Risk of myelofibrosis is defined in accordance with the Myelofibrosis International Prognostic Scoring System (IPSS) OR the Dynamic International Prognostic Scoring System (DIPSS) OR the Age-Adjusted DIPSS. 
17939	No increase in the maximum quantity may be authorised for the 15 mg and 20 mg dose strengths.
17951	PBS subsidised dual oral therapy does not include concomitant use of a combination of: a gliptin, a glitazone or an SGLT2 inhibitor. 
17975	Pharmaceutical benefits that have the form rizatriptan wafer 10 mg (as benzoate) and pharmaceutical benefits that have the form rizatriptan tablet (orally disintegrating) 10 mg (as benzoate) are equivalent for the purposes of substitution.
18024	Pharmaceutical benefits that have the form zoledronic acid injection 5 mg/100 mL vial and pharmaceutical benefits that have the form zoledronic acid injection 5 mg/100 mL bag are equivalent for the purposes of substitution.
18110	Citrulline is not indicated for the treatment of arginase deficiency and other inborn errors of protein metabolism
18193	Eltroxin is not interchangeable with Oroxine, Eutroxsig or Levoxine on a dose to dose basis, and dose titration may be required.
18204	A patient's median life expectancy is determined by the severity of their underlying disease. 
18205	 Patients with underlying myelodysplastic syndrome are considered to have a median life expectancy exceeding five years if they are classified as:- low risk according to the International Prognostic Scoring System (IPSS); or- very low and low risk according to the Revised International Prognostic Scoring System (IPSS-R); or - very low and low risk according to the WHO classification based Prognostic Scoring System (WPSS). 
18206	Patients with underlying myelofibrosis have a median life expectancy exceeding five years if they are classified as:  - low or intermediate risk according to the International Prognostic Scoring System (IPSS); or - low or intermediate-1 risk according to Dynamic International Prognostic Scoring System (DIPSS). 
18269	 For patients who have received continuing treatment with PBS-subsidised eculizumab prior to 1 January 2016, this restriction is limited to 28 weeks of therapy.
18444	A moderate risk of developing breast cancer is if the lifetime breast cancer risk is 1.5 to 3 times the population average. A high risk of developing breast cancer is if the lifetime breast cancer risk is more than 3 times the population average.
18495	Not for use in superficial mycoses
18515	A proportion of patients respond to 150 mg 4-weekly so where a substantial improvement has been obtained with a 300 mg dose it is reasonable to back-titrate dose after initial treatment.
18602	Where authority approval for treatment for both eyes simultaneously is being sought, a maximum quantity of 2 vials may be requested.
18668	Pharmaceutical benefits that have the form pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium trihydrate), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) and pack containing 14 tablets (enteric coated) containing esomeprazole 20 mg (as magnesium), 14 tablets clarithromycin 500 mg and 28 capsules amoxicillin 500 mg (as trihydrate) are equivalent for the purposes of substitution.
18789	The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.
18790	The cobicistat component of the darunavir + cobicistat combination product provides the necessary pharmacokinetic enhancement of darunavir to achieve therapeutic levels of darunavir.
18948	Pharmaceutical benefits that have the form paracetamol 665 mg modified release tablet, 96 and pharmaceutical benefits that have the form paracetamol 665 mg modified release tablet, 192 are equivalent for the purposes of substitution.
18949	Pharmaceutical benefits that have the forms morphine sulfate 10 mg/mL injection and morphine hydrochloride 10 mg/mL injection are equivalent for the purposes of substitution.
19001	Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.
19002	Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride and zoledronic acid.
19004	This pharmaceutical benefit is not PBS-subsidised for primary prevention of breast cancer.
19191	Pharmaceutical benefits that have the form imatinib tablet 100 mg and imatinib capsule 100 mg are equivalent for the purposes of substitution.
19258	Pharmaceutical benefits that have the form imatinib tablet 400 mg and imatinib capsule 400 mg are equivalent for the purposes of substitution.
19273	Allogeneic stem cell transplantation is the preferred therapy for eligible patients achieving a complete remission of Philadelphia positive acute lymphoblastic leukaemia.
19282	Any queries concerning the arrangements to prescribe this drug beyond 24 months may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
19403	Patient dosage is to be determined as per the dose transition table in the Product Information based on the maintenance dose of paliperidone once monthly injection.
19498	Any queries concerning the arrangements to prescribe may be directed to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at www.humanservices.gov.auApplications for authority to prescribe should be forwarded to:Department of Human ServicesComplex Drugs ProgramsReply Paid 9826HOBART TAS 7001
19517	At the time of the authority application, medical practitioners should request sufficient quantity for up to 16 weeks of treatment under this restriction.
19605	Authority approval for sufficient therapy to complete a maximum of 16 weeks of treatment may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
19606	Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
19783	This drug is not subsidised in a child aged 2 to 5 years for use in combination with other preventer medications. PBS subsidy for this drug will therefore cease for a child aged 2 to 5 years who requires a preventer medication in addition to this drug.
19803	Eculizumab is not PBS subsidised to treat TMA caused by conditions other than aHUS, such as TMA occurring in the setting of, but not limited to:a) Active malignancy;b) Active HIV infection;c) Hematopoietic stem cell transplants;d) Various drugs including quinine, high-dose calcineurin inhibitors, antiplatelet agents;e) Certain chemotherapy drugs or immunosuppressant drugs associated with microangiopathic haemolytic anaemia/TMA;f) Active autoimmune diseases;In cases where alternative causes of TMA have not been adequately excluded, additional information may be required from the prescriber to clarify the diagnosis before approval of the application.
19804	The Authority application should be accompanied by a cover letter from the prescriber, providing complete details on:a) Presenting clinical features, including history, acute treatment and medications;b) Results of testing for genetic mutations (if available);c) Family history of aHUS, especially in first-degree relatives;d) Patient's prior history of episodes of active and progressing TMA caused by aHUS;e) Exclusion of alternative causes of TMA;f) History of renal or other organ transplant (if any);g) Any other matters considered relevant by the prescriber.In cases where there are discordant results (for example, an equivocal biopsy result in the absence of objective evidence of haemolysis) the cover letter should articulate the prescriber's interpretation of the clinical data and how a diagnosis of aHUS is supported by the available evidence.
19805	The Authority application should include the results of screening for genetic mutations known to confer a high risk of developing aHUS. The results of genetic screening should be provided whether or not a high-risk mutation has been identified.
19808	WARNING: Eculizumab increases the risk of meningococcal infections (septicaemia and/or meningitis).Please consult the approved PI for information about vaccination against meningococcal infection.
19809	For copies of the ACQ, please contact GlaxoSmithKline Medical Information on 1800 033 109.
19829	All applications should be accompanied by a detailed letter that outlines the objective evidence of high risk of critical organ damage if aHUS recurs. The following evidence may be submitted to establish the patient's level of risk of aHUS recurrence in the short term in the absence of continued treatment with eculizumab:a) Evidence of a mutation known to confer a high risk of aHUS recurrence;b) Past history of recurrent episodes of active and progressive TMA due to aHUS, prior to the episode that led to current use of eculizumab;c) Past family history of aHUS recurrence, especially in first-degree relatives;d) Past history of recurrent aHUS following renal transplant for end-stage renal failure due to aHUS.
19891	For copies of the ACQ and the calculation sheets please contact Novartis Medical Information on 1800 671 203 or medinfo.phauno@novartis.com
19896	At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for four weeks of treatment, according to the specified dosage in the approved Product Information (PI).Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.
19897	At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 4 repeats, according to the specified dosage in the approved Product Information (PI).Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.
19898	At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 6 repeats, according to the specified dosage in the approved Product Information (PI).Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.
19899	At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for 4 weeks and up to 5 repeats, according to the specified dosage in the approved Product Information (PI).Applications for treatment with this drug where the dose and dosing frequency exceeds that specified in the approved PI will not be approved.
19946	Applications for authorisation under this criterion may be made by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Department of Human Services website at www.humanservices.gov.au
19949	Citrulline with carbohydrate is not indicated for the treatment of arginase deficiency and other inborn errors of protein metabolism.
19951	The panic disorder must not be attributable to some known organic factor.
20147	Applications for authorisation under this criterion may be made by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
20371	Pharmaceutical benefits that have a 30 x 2 pack size and a 20 x 3 pack size are equivalent for the purposes of substitution.
20383	A patient who has had progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
20473	A complete remission is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a full recovery of peripheral blood counts with platelets of greater than 100,000 per microliter, and absolute neutrophil count (ANC) of greater than 1,000 per microliter.
20474	A complete remission with partial haematological recovery is defined as bone marrow blasts of less than or equal to 5%, no evidence of disease and a partial recovery of peripheral blood counts with platelets of greater than 50,000 per microliter, and absolute neutrophil count (ANC) of greater than 500 per microliter.
20475	Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time when an assessment is required must cease PBS-subsidised therapy with this agent.
20612	Pharmaceutical benefits that have the forms docetaxel solution concentrate for I.V. infusion 80 mg in 4 mL and docetaxel solution concentrate for I.V. infusion 80 mg in 8 mL are equivalent for the purposes of substitution.
20619	Dasatinib will only be subsidised for patients with acute lymphoblastic leukaemia who are not receiving concomitant PBS-subsidised imatinib mesilate and who are not appropriate for an allogeneic haemopoietic stem cell transplant.
20652	Applications for treatment with this drug where the dosing frequency exceeds 40 mg per fortnight will not be approved.
20995	Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg tablet, tenofovir disoproxil maleate 300 mg tablet, and tenofovir disoproxil fumarate 300 mg tablet are equivalent for the purposes of substitution.
21093	Phlexy-Vits must only be used under strict supervision of a dietician and a paediatrician.
21101	A risk/benefit analysis prior to treatment, and continuous patient monitoring from a health care professional is required for the use of this product, for this indication.
21154	Increase in the maximum quantity or number of units up to 4 may be authorised for the purpose of weight-based loading dose.
21166	Increase in the maximum quantity or number of units up to 4 may be authorised for the purpose of weight-based loading dose.
21169	Increase in the maximum number of repeats of up to 2 may be authorised in patients whose dosing frequency is every 8 weeks.
21265	Pharmaceutical benefits that have the forms docetaxel solution concentrate for I.V. infusion 160 mg in 8 mL and docetaxel solution concentrate for I.V. infusion 160 mg in 16 mL are equivalent for the purposes of substitution.
21334	Pharmaceutical benefits that have the form darunavir tablet 800 mg and pharmaceutical benefits that have the form darunavir tablet 800 mg (as ethanolate) are equivalent for the purposes of substitution.
21501	No increase in the maximum amount or number of units may be authorised.
21739	This drug is not PBS-subsidised for use as monotherapy or in combination with a thiazolidinedione (glitazone), or a glucagon-like peptide-1.
21748	This fixed dose combination is not PBS-subsidised for use as initial therapy or in combination with a thiazolidinedione (glitazone) or a glucagon-like peptide-1.
21817	Pharmaceutical benefits that have the brand DuoResp Spiromax 200/6 powder for inhalation, 120 actuations and pharmaceutical benefits that have the brand Symbicort Turbuhaler 200/6 powder for inhalation, 120 actuations are equivalent for the purposes of substitution.
21821	The treatment must not be used in combination with LABA monotherapy or LAMA/LABA combination therapy.
21822	A LABA includes olodaterol, indacaterol, salmeterol, formoterol or vilanterol.
21823	A LAMA/LABA includes aclidinium/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, or umeclidinium/vilanterol.
21824	Diagnosis of COPD should include measurement of airflow obstruction using spirometry, with confirmation of post-bronchodilator airflow obstruction.
21825	Adherence to current treatment and device (inhaler) technique should be reviewed at each clinical visit and before "stepping up" a patient's medication regimen.
21851	This drug is not PBS-subsidised for use as monotherapy or in combination with a thiazolidinedione (glitazone), or a glucagon-like peptide-1 analogue.
21852	PBS-subsidised dual oral therapy does not include combination use of:a gliptin with an SGLT2 inhibitor; ora gliptin with a glitazone; oran SGLT2 inhibitor with a glitazone.
21855	This drug is not PBS-subsidised for use as monotherapy or in combination with a thiazolidinedione (glitazone), insulin or a glucagon-like peptide-1 analogue.
21858	This fixed dose combination is not PBS-subsidised for initiating dual oral combination treatment or in combination with a thiazolidinedione (glitazone), insulin, a glucagon-like peptide-1 analogue, another dipeptidyl peptidase 4 inhibitor (gliptin), or another SGLT2 inhibitor.
21859	This fixed dose combination is not PBS-subsidised for use as a sole therapy or in combination with a thiazolidinedione (glitazone), a glucagon-like peptide-1 analogue, an insulin, another dipeptidyl peptidase 4 inhibitor (gliptin), or another SGLT2 inhibitor.
21881	This fixed dose combination is not PBS-subsidised for initiating dual oral combination treatment or in combination with a thiazolidinedione (glitazone), a glucagon-like peptide-1 analogue, or another SGLT2 inhibitor.
21882	This fixed dose combination is not PBS-subsidised for initiating dual oral combination treatment or in combination with a thiazolidinedione (glitazone), a glucagon-like peptide-1 analogue, or another dipeptidyl peptidase 4 inhibitor (gliptin).
21957	This fixed dose combination is not PBS-subsidised for use as initial therapy or in combination with a thiazolidinedione (glitazone), insulin or a glucagon-like peptide-1.
21971	The in-use shelf life of Novatears is 6 months from the date of opening.
21974	Formal assessment and correction of inhaler technique should be performed in accordance with the COPD-X Plan (available at http://copdx.org.au/); the assessment and adherence to correct technique should be documented in the patient's medical records.
21976	The treatment must not be used in combination with an ICS/LABA, LABA/LAMA or LAMA, LABA or ICS monotherapy.
21977	An ICS includes fluticasone propionate, fluticasone furoate, budesonide, beclometasone or ciclesonide.
21984	Pharmaceutical benefits that have the form lincomycin 600 mg/2 mL injection, 5 x 2 mL vials and pharmaceutical benefits that have the form lincomycin 600 mg/2 mL injection, 5 x 2 mL ampoules are equivalent for the purposes of substitution.
22058	TREATMENT OF PAEDIATRIC PATIENTS WITH UNCONTROLLED SEVERE ALLERGIC ASTHMAPatients are eligible to commence an 'omalizumab treatment cycle' (initial treatment course with or without continuing treatment course/s) if they satisfy the eligibility criteria as detailed under the initial treatment restriction.Once a patient has either failed to achieve or maintain a response to omalizumab, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 6 month break in PBS-subsidised omalizumab therapy before they are eligible to commence the next cycle. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised omalizumab treatment is stopped to the date of the first application for initial treatment with omalizumab under the new treatment cycle.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.(1) How to prescribe PBS-subsidised omalizumab therapy.(a) Initial treatment:Applications for initial treatment should be made where a patient has received no prior PBS-subsidised omalizumab treatment in this treatment cycle and wishes to commence such therapy.All applications for initial treatment will be limited to provide for a maximum of 28 weeks of therapy for omalizumab.(b) Continuing treatment:Following the completion of the initial treatment course with omalizumab, a patient may qualify to receive up to a further 24 weeks of continuing treatment with omalizumab providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing omalizumab treatment in courses of up to 24 weeks providing they continue to sustain the response.(2) Baseline measurements to determine response:The Department of Human Services will determine whether a response to treatment has been demonstrated based on the baseline measurements of the Asthma Control Questionnaire (ACQ; 5 item version) or ACQ-IA, systemic corticosteroid dose and time-adjusted exacerbation rate, submitted with the Initial authority application for omalizumab. However, prescribers may provide new baseline measurements when a new Initial treatment authority application is submitted and The Department of Human Services will assess response according to these revised baseline measurements.(3) Re-commencement of treatment after a 6 month break in PBS-subsidised therapy:A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised omalizumab therapy of at least 6 months, must re-qualify for initial treatment with respect to the indices of disease severity (systemic corticosteroid dose, Asthma Control Questionnaire (ACQ-5) score or ACQ-IA, and relevant exacerbation history). Patients must have received optimised standard therapy, at adequate doses and for the minimum period specified, immediately prior to the time the new baseline assessments are performed.(4) Monitoring of patients:Anaphylaxis and anaphylactoid reactions have been reported following first or subsequent administration of omalizumab (see Product Information). Patients should be monitored post-injection, and medications for the treatment of anaphylactic reactions should be available for immediate use following administration of omalizumab. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.
22065	Authority approval for sufficient therapy to complete a maximum of 28 weeks of treatment under the initial restriction or 24 weeks of treatment under the continuing restriction may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
22133	Pharmaceutical benefits that have the brand DuoResp Spiromax 400/12 powder for inhalation, 2 x 60 actuations and pharmaceutical benefits that have the brand Symbicort Turbuhaler 400/12 powder for inhalation, 2 x 60 actuations are equivalent for the purposes of substitution.
22191	If the wound has not healed during this period, further use is to be discontinued after initial pack, no repeats. Where wounds remain unresponsive to standard treatment, patient should be referred on to a specialist.
22216	Biosimilar prescribing policyPrescribing of the biosimilar brand Inflectra or Renflexis is encouraged for treatment naive patients.
22274	The treatment must not be used in combination with an ICS/LABA, LAMA, LABA, or SAMA
22275	A SAMA includes ipratropium
22278	Patients receiving clozapine under the PBS listing must be registered in the clozapine patient monitoring program relevant for the brand of clozapine being prescribed and dispensed: Pfizer ClopineCentral.
22291	The treatment must not be used in combination with a LAMA/LABA or SAMA
22292	The treatment must not be used in combination with an ICS/LABA, or LAMA/LABA
22293	An ICS/LABA includes budesonide/formoterol, fluticasone/salmeterol, or fluticasone/vilanterol
22301	This product is not indicated for the initiation of treatment in asthma
22302	The patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA)
22326	Pharmaceutical benefits that have the forms baclofen 10 mg/5 mL intrathecal injection, 5 mL ampoule, baclofen 10 mg/5 mL intrathecal injection, 5 x 5 mL ampoules and baclofen 10 mg/5 mL intrathecal injection, 10 x 5 mL ampoules are equivalent for the purposes of substitution.
22339	It is recommended that an application for the first continuing treatment is submitted to the Department of Human Services at the time of the 12 week assessment, to ensure continuity of treatment for those patients who meet the first continuing treatment criteria for PBS-subsidised treatment with this drug.
22372	The in-use shelf life of Evolve carmellose 0.5% and Evolve hypromellose 0.3% is 3 months from the date of opening.
22404	Authority applications for increased repeats up to a maximum of 5 may be authorised for patients requiring dose optimisation for this condition not adequately provided by other strengths of this drug.
22470	Not for use in vulvovaginal candida infections.
22506	The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au
22551	An acute event may be a clinical or external event that leads to upper motor neuron lesions resulting in spasticity for example stroke, traumatic brain injury, spinal cord injury, infection or hypoxia.
22579	For copies of the ACQ, please contact AstraZeneca Medical Information on 1800 805 342.
22705	Patient must be aged 18 years or older.
22706	Patient must be aged 12 years or over.
22905	Following completion of the initial PBS subsidised course, further applications for treatment will be assessed under the continuing treatment restriction.
23025	Pharmaceutical benefits that have form pack size clonazepam 500 microgram tablet, 100 and clonazepam 500 microgram tablet, 50 are equivalent for the purposes of substitution.
23145	This drug is not PBS-subsidised for use as monotherapy or in combination with a thiazolidinedione (glitazone), insulin or a glucagon-like peptide-1.
23191	Interruption of treatment should be considered if serum ferritin levels fall consistently below 500 microgram/mL.
23291	Pharmaceutical benefits that have form pack size isotretinoin 20 mg capsule, 60 and isotretinoin 20 mg capsule, 30 are equivalent for the purposes of substitution.
23690	The level of iron in this product is below the recommended daily intake (RDI) for infants and should be supplemented by other sources where appropriate.
23717	Check patient adherence to lower dose proton pump inhibitor before "stepping-up" therapy.
23718	Standard dose proton pump inhibitors are appropriate step-down therapy from high dose proton pump inhibitors.
23729	Low dose proton pump inhibitors are appropriate step-down therapy from standard dose proton pump inhibitors.
23730	A low dose proton pump inhibitor includes: lansoprazole 15mg, omeprazole 10mg, pantoprazole 20mg and rabeprazole 10mg.
23751	Pharmaceutical benefits that have the form atazanavir 300 mg capsule, 30 and pharmaceutical benefits that have the form atazanavir 300 mg capsule, 60 are equivalent for the purposes of substitution.
23761	This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamfetamine sulfate or modafinil.
23767	This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamfetamine sulfate or armodafinil.
23791	Pharmaceutical benefits that have the forms filgrastim 300 microgram/0.5 mL injection, 10 x 0.5 mL syringes and filgrastim 300 microgram/0.5 mL injection, 5 x 0.5 mL syringes and filgrastim 300 microgram/mL injection, 10 x 1 mL vials are equivalent for the purposes of substitution.
23792	Pharmaceutical benefits that have the forms filgrastim 480 microgram/0.5 mL injection, 10 x 0.5 mL syringes and filgrastim 480 microgram/1.6 mL injection, 10 x 1.6 mL vials and filgrastim 480 microgram/0.5 mL injection, 5 x 0.5 mL syringes are equivalent for the purposes of substitution.
23865	Treatment should be initiated by a specialist knowledgeable in the use of potent opioids for the management of chronic breathlessness.
23866	Applications for an increased maximum quantity to provide for 1 month's supply of this drug will be authorised.
23936	Prescribers must include the proprietary name (brand) on the prescription to ensure the appropriate item is approved.
23951	Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib or ponatinib at any one time and must not be receiving concomitant interferon alfa therapy.
23973	Authority applications for increased quantities/ repeats (where relevant) may be made by telephone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
24034	Patients are eligible to receive a loading dose for the first dose of a treatment cycle while receiving induction treatment. Two prescriptions are required, the first prescription for the loading dose at a dose no higher than 0.8mg per m2, and the second prescription for two doses at a dose no higher than 0.5mg per m2. Both prescriptions must be submitted with the initial application.
24035	Once a patient achieves complete remission or complete remission with partial haematological recovery, a new prescription must be written under the consolidation treatment phase.
24053	Patient will be eligible for a maximum of one PBS-subsidised prescription as initial therapy to enable their response to treatment with sapropterin to be assessed.
24113	Pharmaceutical benefits that have the form apomorphine injection 30 mg/3 mL pen device and pharmaceutical benefits that have the form apomorphine injection 30 mg/3 mL cartridge are equivalent for the purposes of substitution.
24133	The listing is intended to provide treatment for syphilis in Aboriginal and Torres Strait Islander patients in non-remote areas.
24187	This formulation is suitable for patients aged 3 and older.
24211	Pharmaceutical benefits that have the form tiotropium 18 microgram powder for inhalation and pharmaceutical benefits that have the form tiotropium 13 microgram powder for inhalation are equivalent for the purposes of substitution.
24355	PAH (WHO Group 1 pulmonary hypertension) currently includes the following subtypes:Idiopathic PAHHeritable PAH BMPR2 mutationALK-1, ENG, SMAD9, CAV1, KCNK3 mutationsOther mutationsDrugs and toxins induced PAHPAH associated with: Connective tissue diseaseHuman immunodeficiency virus (HIV) infectionPortal hypertensionCongenital heart diseaseSchistosomiasis
24368	Pharmaceutical benefits that have the form phenelzine 15 mg tablet, 60 and pharmaceutical benefits that have the form phenelzine 15 mg tablet, 100 are equivalent for the purposes of substitution.
24626	Increased maximum quantity will be authorised where a patient's weight is greater than 125 kg.
24661	Increased maximum quantity will be authorised where a patient requires a new loading dose due to a break in therapy of more than 1 week but less than 6 weeks from the last dose or a patient's weight is greater than 125 kg.
24733	Pharmaceutical benefits that have the form capsule 250 mg are equivalent for the purposes of substitution.
24951	Pharmaceutical benefits that have the forms sevelamer hydrochloride 800 mg and sevelamer carbonate 800 mg tablet are equivalent for the purposes of substitution
24978	This product does not contain any vitamins, minerals or trace elements and is not intended as a sole source of nutrition
25071	Patient should be treated with the recommended dose of pembrolizumab according to the TGA-approved Product Information.
25218	Pharmaceutical benefits that have the form pack size risperidone 500 microgram tablet, 20 and pharmaceutical benefits that have the form pack size risperidone 500 microgram tablet, 60 are equivalent for the purposes of substitution.
25279	Pharmaceutical benefits that have the form epoprostenol 500 microgram injection vial & diluent and pharmaceutical benefits that have the form epoprostenol 500 microgram injection vial are equivalent for the purposes of substitution.
25280	Pharmaceutical benefits that have the form epoprostenol 1.5 mg injection vial & diluent and pharmaceutical benefits that have the form epoprostenol 1.5 mg injection vial are equivalent for the purposes of substitution.
25291	Pharmaceutical benefits that have the form levodopa 200 mg + carbidopa 50 mg modified release tablet, 100 and pharmaceutical benefits that have the form levodopa 200 mg + carbidopa 50 mg modified release tablet, 60 are equivalent for the purposes of substitution.
25296	This product is low in folic acid, choline and methionine and is not intended as a sole source of nutrition.
25398	This grandfather restriction will cease to operate from 12 months after the date specified in the clinical criteria.
25425	Treatment is intended to prevent mother-to-child transmission of hepatitis B in the third trimester of pregnancy and to reduce the risk of viral reactivation in the mother up to 12 weeks post-partum.
25574	Real time online applications for increased maximum quantities/repeats may be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/organisations/health-professionals/services/medicare/hpos/services/request-authority-using-online-pbs-authorities-hpos).Phone applications for increased maximum quantities/repeats may be made by calling 1800 888 333.Written authority applications for increased maximum quantities/repeats can be uploaded online through HPOS form upload or mailed to:Pharmaceutical Benefits SchemeReply Paid 9857[Your capital city]
25594	Increased maximum amounts can be requested where a patient's weight is greater than 125 kg.
25598	Consider consultation with a multidisciplinary pain service prior to, or after commencement of this medication.
25651	This treatment is not suitable for 'as-required' pain relief.
25698	This treatment is not recommended for use in ambulant patients.
25744	Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.auApplications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hposOr mailed to:Services AustraliaComplex DrugsReply Paid 9826HOBART TAS 7001
25745	Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
25796	Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 888 333.
25871	The Services Australia website (www.servicesaustralia.gov.au) has details of the accepted toxicities, including severity, which will be accepted for the purposes of exempting a patient from the requirement of treatment with optimised asthma therapy.
25873	Authority approval for sufficient therapy to complete the balance of supply may be requested by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
25874	Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.servicesaustralia.gov.au or www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient's medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).
25896	The criterion that limits breaks in treatment with pertuzumab under this restriction has been temporarily modified due to the current risk of COVID-19. This allows an extended break in therapy with PBS-subsidised pertuzumab in patients who are at risk of COVID-19.
25917	This drug is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD) or for allergen-induced or exercise-induced bronchoconstriction in the absence of asthma.
26200	TREATMENT OF PATIENTS WITH SEVERE ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tocilizumab for a patient who has severe active systemic juvenile idiopathic arthritis (sJIA).From 1 May 2012, a patient receiving PBS-subsidised tocilizumab therapy is considered to be in a treatment cycle. Under these arrangements, within a single treatment cycle, a patient may:(i) continue to receive long-term treatment with PBS-subsidised tocilizumab while they continue to show an adequate response to therapy, and(ii) fail to respond, or to sustain a response, to PBS-subsidised tocilizumab twice.Once a patient has either failed or ceased to sustain an adequate response to 2 courses of treatment, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 12 month break in PBS-subsidised tocilizumab therapy before they are eligible to commence another cycle. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised tocilizumab treatment was approved to the date of the first application for initial treatment with tocilizumab under the new treatment cycle.A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, will not be considered as a treatment failure.How to prescribe PBS-subsidised tocilizumab treatment therapy after 1 May 2012.(1) Initial treatment.Applications for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised tocilizumab treatment and wishes to commence such therapy (Initial 1 - New patient); or(ii) a patient has received the first course of PBS-subsidised (initial or continuing) tocilizumab therapy in a treatment cycle and is deemed to have failed to respond or sustain an adequate response and the treating physician wishes to trial a second course, provided any break in therapy is less than 12 months (Initial 2 - retrial or recommencement of treatment after a break of less than 12 months); or(iii) a patient wishes to recommence treatment with tocilizumab following a break in PBS-subsidised therapy of less than 12 months (Initial 2 - retrial or recommencement of treatment after a break of less than 12 months).(iv) a patient wishes to recommence treatment following a break in PBS-subsidised tocilizumab therapy of more than 12 months (Initial 3 - recommencement of a new treatment cycle after a break of more than 12 months).Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy.A patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.(2) Continuing treatment.Following the completion of an initial treatment course with tocilizumab, a patient may qualify to receive up to 24 weeks of continuing treatment with this drug provided they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing tocilizumab treatment in courses of up to 24 weeks provided they continue to sustain the response. It is recommended that a patient be reviewed in the 4 weeks prior to completing their current course of treatment to ensure uninterrupted tocilizumab supply.Assessments of response to a course of PBS-subsidised therapy must be conducted after a minimum of 12 weeks of treatment and no later than 4 weeks from the completion of treatment. Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.For the second and subsequent courses of PBS-subsidised tocilizumab, it is recommended that a patient be assessed for response in the 4 weeks prior to completing their current course of treatment and that an application is posted to Services Australia no later than 2 weeks prior to the patient completing their current treatment course.(3) Treatment cycle.Once initial treatment with PBS-subsidised tocilizumab is approved, a patient deemed to have failed to respond to the first course of treatment may have a second course without having to requalify with respect to the indices of disease severity (joint count, fever and/or CRP level and platelet count), except if the patient has had a break in therapy of more than 12 months.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction.(4) Baseline measurements to determine response.Whether an adequate response to treatment has been demonstrated or not will be based on the relative change from relevant baseline measurements of the joint count, fever and/or CRP level and platelet count submitted with the first authority application for tocilizumab.Where a patient is deemed to have failed to respond or to sustain an adequate response to the first course of therapy in a treatment cycle, prescribers may provide new baseline measurements for the second course of treatment within that cycle. Assessment of response according to these revised baseline measurements may then occur. If new baseline measurements are not submitted with the initial application for the second course of treatment, then those submitted with the first course will be used to assess response to the second course.(5) Recommencement of treatment after a 12 month break in PBS-subsidised therapy.A patient who wishes to start a second or subsequent treatment cycle following a break in PBS-subsidised tocilizumab therapy of at least 12 months, must requalify for treatment under the Initial 3 treatment restriction.(6) Withdrawal of treatment after sustained remission.Withdrawal of treatment with tocilizumab should be considered in a patient who has achieved and sustained complete remission of disease for 12 months. A demonstration of response to the current treatment should be submitted to Services Australia at the time treatment is ceased.
26237	The in-use shelf life of Cationorm is 3 months from the date of opening.
26251	Pharmaceutical benefits that have the form salbutamol 100 microgram/actuation inhalation, 200 actuations are equivalent for the purposes of substitution.
26292	Pharmaceutical benefits that have the form imipramine hydrochloride 25 mg tablet in a pack size of 50 can be substituted for a pack size of 100 in the case of a shortage.
26327	Pharmaceutical benefits that have the form ceftriaxone 2 g injection, 1 vial, pharmaceutical benefits that have the form ceftriaxone 2 g injection, 5 vials, and pharmaceutical benefits that have the form ceftriaxone 2 g injection, 10 vials are equivalent for the purposes of substitution.
26330	Pharmaceutical benefits that have the form ceftriaxone 1 g injection, 1 vial, pharmaceutical benefits that have the form ceftriaxone 1 g injection, 5 vials, and pharmaceutical benefits that have the form ceftriaxone 1 g injection, 10 vials are equivalent for the purposes of substitution.
26357	No increase in the maximum quantity or number of units may be authorised for applications for treatment of one eye.
26358	In accordance with the Therapeutic Goods Administration (TGA)-approved Product Information, this PBS listing currently intends for once daily dosing only. Divided dosing is not intended (e.g. 20 mg in the mornings, 30 mg in the evenings). Where applications (either on the same day or on separate days) for multiple strengths are sought, repeats should only be sought for the listed target strength.
26425	Pharmaceutical benefits that have the form aflibercept 0.09mL injection syringe and pharmaceutical benefits that have the form aflibercept 0.1mL injection vial are equivalent for the purposes of substitution.
26443	Increased repeats of up to 11 may be requested for doses of 840 mg administered every 2 weeks
26463	There is no specific Medical Benefits Schedule item for CYP2C9 metabolising enzyme status testing.
26477	The maximum quantity and maximum number of repeats are based on the following treatment protocol: one day of treatment per week for six weeks, then every two weeks for 12 weeks, then monthly thereafter. This differs from the Product Information. Requests for increased maximum quantities/maximum repeats will not be considered.
26492	Treatment may be continued by a non-specialist prescriber without need for consultation with a specialist.
26570	This product is not PBS-subsidised for use as 'maintenance and reliever' therapy.
26571	Pharmaceutical benefits that have the forms mebendazole 100 mg tablet and mebendazole 100 mg chewable tablet are equivalent for the purposes of substitution.
26572	Pharmaceutical benefits that have the forms sodium bicarbonate 1.76 g + sodium citrate 630 mg + citric acid 720 mg + tartaric acid 890 mg powder for oral liquid and sodium bicarbonate 1.76 g + citric acid 720 mg + sodium citrate 630 mg + tartaric acid 890 mg effervescent granules are equivalent for the purposes of substitution.
26576	An outcome on the authority application is not immediate, but will follow in due course. Electronic upload is encouraged to reduce processing time.
26584	This product is not PBS-subsidised for use as 'anti-inflammatory reliever' therapy for mild asthma.
26589	Obinutuzumab is not to be used as monotherapy or in combination with anti-cancer drugs other than chlorambucil under this restriction. For use with venetoclax, refer to the separate listing for this purpose.
26615	Details of the toxicities, including severity, which will be accepted for the purposes of administering this restriction can be found on the Services Australia website at www.servicesaustralia.gov.au
26616	For details on the appropriate minimum exercise program that will be accepted for the purposes of administering this restriction, please refer to the Services Australia website at www.servicesaustralia.gov.au
26624	Pharmaceutical benefits that have the form norethisterone 1 mg + ethinylestradiol 35 microgram tablet in a 4 pack of 28 tablets can be substituted for a 3 pack of 28 tablets in the case of a shortage.
26654	Details of the toxicities, including severity, which will be accepted as a reason for exempting a patient from the requirement for 6 weeks treatment with phototherapy, methotrexate, ciclosporin, apremilast or acitretin can be found on the Services Australia website (www.servicesaustralia.gov.au).
26672	This drug is not PBS-subsidised for use in patients with multiple myeloma who have received two or more prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent, or, who are refractory to both a PI and an immunomodulatory agent, as monotherapy.
26710	Authority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as 'combination therapy'.
26759	Where multiple strengths of this drug are sought, the combined number of repeats sought for each strength should not exceed 5. If the optimal strength is still to be determined by the end of the initial PBS supply, prescribers are reminded that further supplies of the optimal strength may be obtained via the Continuing treatment listing via a telephone/online authority application.
26832	The treatment must not be prescribed under this restriction for any of the following PBS-indications: (i) gastro-oesophageal reflux disease (where the word 'complex' is absent), (ii) scleroderma oesophagus, (iii) pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion, (iv) peptic ulcer, (v) eradication of Helicobacter pylori.
26833	A standard dose proton pump inhibitor is one of: esomeprazole 20 mg, lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg, rabeprazole 20 mg.
26856	The initiation pack is intended for use at the commencement of treatment and for re-initiation of therapy following treatment interruption. The first prescription for the 920 microgram capsules should occur under the Initial treatment restriction. Subsequent prescriptions should then occur under the Continuing treatment restriction. If treatment interruption of more than 14 consecutive days occurs for reasons other than lack of efficacy, apply under the Continuing treatment restriction for each of the Initiation pack and 920 microgram capsules. If treatment interruption occurs within the first 14 days, or, for more than 7 consecutive doses between treatment Days 15 to 28, re-apply for an initiation pack under the 'Initial treatment' treatment phase.
26891	This product is not PBS-subsidised for the treatment of chronic obstructive pulmonary disease (COPD).
26897	Pharmaceutical benefits that have the form desmopressin acetate 10 microgram/actuation nasal spray, 50 actuations can be substituted for desmopressin acetate 10 microgram/actuation nasal spray, 60 actuations in the case of a shortage.
26898	A high dose proton pump inhibitor is: esomeprazole 40 mg.
26912	Instructions on the use of the Eczema Area and Severity Index and copyright details can be found here:https://www.dupixent.co.uk/-/media/EMS/Conditions/Dermatology/Brands/Dupixent-UK/global/1051-EASI-Leaflet-v6-webready.pdf
26913	Instructions on the use of the Dermatology Life Quality Index and copyright details can be found here:https://www.cardiff.ac.uk/medicine/resources/quality-of-life-questionnaires/dermatology-life-quality-index
26994	For copies of the ACQ and the calculation sheets please contact Sanofi Medical Information on 1800 818 806 or MedInfo.Australia@sanofi.com
27024	Instructions on the use of the Physician's Global Assessment (5-point scale) can be obtained from Sanofi Medical Information on 1800 818 806 or MedInfo.Australia@sanofi.com
27030	Formal assessment and correction of inhaler technique should be performed in accordance with the National Asthma Council (NAC) Information Paper for Health Professionals on Inhaler Technique (available at www.nationalasthma.org.au); the assessment and adherence to correct technique should be documented in the patient's medical records. Patients can obtain support with inhaler technique through their local Asthma Foundation (1800 645 130).
27047	Pharmaceutical benefits that have the form adalimumab 20 mg/0.2 mL syringes and pharmaceutical benefits that have the form adalimumab 20 mg/0.4 mL syringes are equivalent for the purposes of substitution
27048	Pharmaceutical benefits that have the form adalimumab 40 mg/0.4 mL pen devices and pharmaceutical benefits that have the form adalimumab 40 mg/0.8 mL pen devices are equivalent for the purposes of substitution
27049	Pharmaceutical benefits that have the form adalimumab 40 mg/0.4 mL syringes and pharmaceutical benefits that have the form adalimumab 40 mg/0.8 mL syringes are equivalent for the purposes of substitution
27111	Two completed authority prescriptions should be submitted with every initial application for this biological medicine.Prescribing the 40 mg presentation:One prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.Prescribing the 80 mg presentation:One prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.
27130	Prescribing the 80 mg presentation:Two completed authority prescriptions may be submitted with every initial application for this biological medicine. One prescription for an induction dose of 80 mg and no repeats and the second prescription for 2 doses of 40 mg and 3 repeats.
27134	Pharmaceutical benefits that have a pack size of 1 may be substituted for pharmaceutical benefits that have a pack size of 2, in combinations equivalent to the maximum quantity number of units.
27157	In accordance with the Therapeutic Goods Administration (TGA)-approved Product Information, this PBS listing currently intends for once daily dosing only. Divided dosing is not intended (e.g. 18 mg in the mornings, 36 mg in the evenings). Where applications (either on the same day or on separate days) for multiple strengths are sought, repeats should only be sought for the listed target strength.
27162	Authorisation for an increased maximum quantity, up to double the stated 'Max qty packs' value, may be sought.
27170	Continuing therapy by a nurse practitioner may include dose titrations/changes, but only after therapy was initiated by a medical practitioner.
27176	The Services Australia website (www.servicesaustralia.gov.au) has details of the toxicities, including severity, which will be accepted where one is claimed.
27179	Requests for increased quantities may be sought based on daily doses not exceeding 20 mg/kg/day (in line with the Product Information) for up to 4 weeks per dispensing.
27180	PBS-subsidy does not currently include Lennox-Gastaut syndrome
27199	Real time online applications for increased maximum quantities/repeats may be made using the Online PBS Authorities system (see www.servicesaustralia.gov.au/organisations/health-professionals/services/medicare/hpos/services/request-authority-using-online-pbs-authorities-hpos).Written authority applications for increased maximum quantities/repeats can be uploaded online through HPOS form upload or mailed to:Pharmaceutical Benefits SchemeReply Paid 9857[Your capital city]
27221	TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, golimumab, infliximab, tofacitinib and vedolizumab for adult patients with ulcerative colitis. Patients are eligible for PBS-subsidised treatment with either adalimumab, golimumab, infliximab, tofacitinib or vedolizumab at any one time.Where the term 'biological medicine' appears in the following notes and restrictions, it refers to the tumour necrosis factor (TNF) alfa antagonists (adalimumab, golimumab, infliximab), the alphta-4 beta-7 integrin inhibitor (vedolizumab) and the Janus kinase (JAK) inhibitor (tofacitinib).From 1 July 2021, under the PBS, all adult patients will be able to commence a treatment cycle where they may trial PBS-subsidised biological medicine without having to experience a disease flare when swapping to one of the alternate agents. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a PBS subsidised biological medicine while they continue to show a response to therapy.A patient who received PBS-subsidised biological medicine treatment prior to 1 July 2021 is considered to start their first cycle as of 1 July 2021. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once. Once a patient has either failed or ceased to respond to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised therapy before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a PBS-subsidised biological medicine under the new treatment cycle.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction.A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 5 years, may commence a new treatment cycle under the Initial 3 treatment restrictions.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine treatment after 1 July 2021.(1) Initial treatment.Applications for initial treatment should be made where:(i) an adult patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient ); or(ii) an adult patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine therapy of less than 5 years) [further details are under 'Swapping therapy' below]; or(iii) an adult patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same agent (Initial 2 - Change or Recommencement of treatment after a break in biological medicine therapy of less than 5 years); or(iv) an adult patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - recommencement of treatment after a break in biological medicine of more than 5 years).Treatment authorisations under Initial 1, Initial 2 and Initial 3 will be limited to provide for a maximum of 16 weeks of therapy for adalimumab and tofacitinib, 14 weeks of therapy for golimumab, infliximab and vedolizumab.A patient must be assessed for response to a course of initial PBS-subsidised treatment following a minimum of 12 weeks of treatment for adalimumab or infliximab subcutaneous form or vedolizumab subcutaneous form, a minimum of 8 weeks for tofacitinib, and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab intravenous form or vedolizumab intravenous form.Infliximab subcutaneous form only:Initial treatment to subcutaneous form of infliximab should be permitted after administration of at least 2 initial intravenous infusions of infliximab. A maximum quantity and number of repeats to provide for weeks 6, 8, 10, 12, 14 and 16 will be authorised.Vedolizumab subcutaneous form only:initial treatment to subcutaneous form of vedolizumab should be permitted after administration of at least 2 of the 3 initial intravenous infusions of vedolizumab. Where two initial doses of vedolizumab (at weeks 0 and 2) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. A maximum quantity and number of repeats to provide for weeks 6, 8, 10, 12, 14 and 16 will be authorised. Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity to provide for weeks 14 and 16 will be authorised.(2) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.Adalimumab and infliximab only:For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment under the Initial 1, Initial 2 or Initial 3 treatment restrictions.For the second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.Infliximab patients:A patient may swap between the intravenous and subcutaneous forms of infliximab at any time under the continuing treatment restrictions provided the patient has demonstrated adequate response to treatment with infliximab.Vedolizumab patients:A patient may swap between the intravenous and subcutaneous forms of vedolizumab at any time under the continuing treatment restrictions provided the patient has demonstrated adequate response to treatment with vedolizumab.(3) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine treatment is approved, a patient may swap to an alternate biological medicine treatment within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. Mayo clinic score or partial Mayo clinic score), or the prior corticosteroid therapy and immunosuppressive therapy.A patient may trial an alternate biological medicine treatment at any time, regardless of whether they are receiving therapy (initial or continuing) at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug once within the same treatment cycle.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course (except tofacitinib) will be deemed to have failed treatment with that agent, unless they have experienced a serious adverse reaction of a severity necessitating permanent treatment withdrawal.(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify under Initial 3 treatment restriction and meet the relevant criteria with respect to the scores of disease severity.
27235	Request an appropriate maximum quantity based on testing response to treatment for 7 days, with the number of packs being a whole number, based on dosing no greater than 20 mg/kg per day. Combinations of the sachets and tablets are permitted to reduce high tablet burden.
27236	Pharmaceutical benefits that have the forms tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg tablet, tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg tablet, tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg tablet, and tenofovir disoproxil succinate 301 mg with emtricitabine 200 mg tablet are equivalent for the purposes of substitution.
27245	Request an appropriate maximum quantity (with the number of packs being a whole number) to provide approximately 30 days treatment duration per dispensing, based on dosing no greater than 20 mg/kg per day.
27246	This PBS listing intends to subsidise up to 13 cumulative months (assuming 1 month consists of 30 days) of treatment during the pre-conception phase per known pregnancy. The time taken to conceive can vary for each patient, but where this treatment phase of 'pre-conception through to when pregnancy becomes first known' exceeds a cumulative 13 months, continued treatment beyond this time up to the point of conception, is not PBS subsidised.13 cumulative months comprises of the time taken to achieve desired phenylalanine level control and the time taken for pregnancy to become known (e.g. If it takes 3 months to reach desired phenylalanine level control, 10 months of PBS-subsidised treatment remain in which to achieve pregnancy; if it takes only 1 month to reach desired phenylalanine level control, 12 months of PBS-subsidised treatment remain in which to achieve pregnancy)
27251	Request an appropriate number of repeats (whole number) relative to the expected birth date such that treatment is not continued post-partum by a whole prescription quantity. If the expected birth date is within the next 30 days at the time of the authority application, do not request repeats.
27252	This PBS listing intends to subsidise treatment only whilst the patient is pregnant. Treatment is to be discontinued upon birth under this listing. Whilst a patient may benefit from continued treatment post-partum, continued treatment with this drug post-partum is not PBS subsidised in the absence of actively trying to conceive again/a known subsequent pregnancy.
27279	TREATMENT OF PAEDIATRIC PATIENTS WITH REFRACTORY CROHN DISEASE The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) for paediatric patients with adalimumab for severe refractory Crohn disease and infliximab for moderate to severe refractory Crohn disease. Where the term "biological medicines" appears in the following notes and restrictions, it refers to adalimumab and infliximab only.A patient is eligible for PBS-subsidised treatment with only one PBS-subsidised biological medicine at any one time.From 1 August 2015, under the PBS, patients will be able to commence a treatment cycle where they may trial a PBS-subsidised biological medicine without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy.A patient who received PBS-subsidised biological medicine treatment prior to 1 August 2015 is considered to have started their treatment cycle as of 1 August 2015.Within the same treatment cycle, a paediatric patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than twice.Once a patient has either failed, or ceased to respond to treatment for this condition 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy for this condition before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.A patient who has failed fewer than 3 trials of biological medicine therapy in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle.A patient who has failed 3 trials or fewer of biological medicine therapy in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine therapy after 1 August 2015.(1) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised biological medicine therapy in this treatment cycle and wishes to commence such therapy - Initial 1 (new patient); or(ii) a patient has received prior PBS-subsidised (initial or continuing) biological medicine therapy and wishes to trial an alternate agent - Initial 2 (Change or Re-commencement of treatment after a break in therapy of less than 5 years ) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to re-commence treatment with a specific biological medicine following a break in PBS-subsidised therapy with that agent - Initial 2 (Change or Re-commencement of treatment after a break in therapy of less than 5 years ); or(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years - Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years).Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy for adalimumab and 14 weeks of therapy for infliximab.From 1 August 2015, a patient must be assessed for response to any course of initial PBS-subsidised biological therapy following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab, and this assessment must be conducted no later than 4 weeks from the date that course was ceased.Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(2) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response.It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(3) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine therapy is approved, a patient with severe disease may swap if eligible to the alternate biological medicine within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. Paediatric Crohn Disease Activity Index (PCDAI) Score, confirmation of Crohn disease), or the prior conventional therapies of corticosteroid therapy, immunosuppressive therapy or enteral nutrition.A patient cannot swap to a biological medicine if they have failed to respond to prior treatment with that drug twice within the same treatment cycle.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment within the timeframes specified in the relevant restriction.A patient who is not able to complete an initial treatment course for a biological medicine will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(4) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the PCDAI submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and eligibility for continuing treatment must be assessed according to these revised baseline measurements.(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to recommence treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity under the Initial 3 restriction. A retrial of conventional therapies is not required.
27281	A maximum quantity and number of repeats to provide for an initial 16 week course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 for patients 40 kg or greater (for patients 40 kg or less, the course is a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14) may be requested.
27324	A prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk score can be calculated here: https://www.mdcalc.com/imdc-international-metastatic-rcc-database-consortium-risk-model-metastatic-renal-cell-carcinoma.One point is assigned for each of:(i) a time of diagnosis to systemic therapy of less than 1 year(ii) a Karnofsky Performance Status of less than 80%(iii) a haemaglobin less than the lower limit of normal(iv) a corrected calcium level greater than the upper limit of normal(v) a neutrophil count greater than the upper limit of normal(vi) a platelet count greater than the upper limit of normalStated normal reference ranges may vary depending on the laboratory providing the measurement. 'Normal' here refers to the individual laboratory's stated normal reference range.Favourable IMDC risk is a score of 0.Intermediate IMDC risk is a score of 1 to 2.Poor IMDC risk is a score of 3 to 6.Document any IMDC risk score assessment in the patient's medical records.
27334	TREATMENT OF ADULT AND ADOLESCENT PATIENTS WITH UNCONTROLLED SEVERE ASTHMAThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines benralizumab, dupilumab, mepolizumab and omalizumab for uncontrolled severe asthma. Therefore, where the term 'biological medicine' appears in notes and restrictions, it refers to benralizumab, dupilumab, mepolizumab and omalizumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.A patient receiving PBS-subsidised treatment for uncontrolled severe asthma is able to commence a treatment cycle where they may trial a biological medicine without having to experience a disease flare when swapping to an alternate biological medicine within the same treatment cycle.Under these arrangements, within a treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.A patient currently receiving PBS-subsidised treatment as of 1 April 2021 is considered to have started a cycle of treatment.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.Once a patient has either failed to achieve or sustain a response to treatment 4 times, they are deemed to have completed a single treatment cycle. They must have at least a 12-month break in PBS-subsidised biological medicine therapy before they are eligible to recommence another new treatment cycle [further details are under 'Recommencement of treatment after a treatment break in PBS-subsidised therapy' below].The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine is ceased until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine treatment for uncontrolled severe asthma.(1) Initial treatment:Applications for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 restriction); or(ii) a patient has received prior PBS-subsidised treatment with a biological medicine and wishes to recommence a new treatment cycle with this biological medicine following a treatment break in PBS-subsidised therapy (Initial 1 restriction); or(iii) a patient has received prior PBS-subsidised biological medicine therapy and wishes to trial an alternate biological medicine within the same treatment cycle (Initial 2 restriction) - [further details are under 'Swapping therapy' below].All applications for initial treatment will be limited to provide for a maximum of up to 32 weeks of therapy of a biological medicine. It is recommended that a patient be reviewed in the month prior to completing their course of initial treatment to ensure uninterrupted biological medicine supply.(2) Continuing treatment:Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that biological medicine providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed the month prior to completing their current course of treatment to ensure uninterrupted biological medicine supply.(3) Baseline measurements to determine response:Baseline measurements of the Asthma Control Questionnaire (ACQ; 5 item version) or oral corticosteroid dose submitted with the Initial authority application for a biological medicine must be used to determine whether an adequate response to treatment has been achieved or sustained.For patients transitioned from the paediatric to the adolescent/adult restriction, the exacerbation history may also be used to determine response.However, prescribers may provide new baseline measurements when a new Initial treatment authority application is submitted and these new baseline measurements may be used to assess response.(4) Swapping therapy within the same treatment cycle.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine at any time by qualifying under an Initial 2 restriction.However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.Within the same treatment cycle a patient may alternate between therapy with any biological medicine of their choice (1 at a time) providing:(i) they have not received PBS-subsidised treatment with that particular biological medicine previously; or(ii) they have demonstrated an adequate response to that particular biological medicine if they have previously trialled it on the PBS; and(iii) they have not previously failed to respond to treatment with all 4 biological medicines in this treatment cycle.(5) Re-commencement of a new treatment cycle after a treatment break in PBS-subsidised therapy:A patient who wishes to trial a second or subsequent new treatment cycle, following a break in PBS-subsidised therapy of at least 12 months (in patients who have failed to achieve or ceased to sustain a response to treatment 4 times within a treatment cycle), must re-qualify through an Initial 1 restriction.(6) Monitoring of patients:Omalizumab only:Anaphylaxis and anaphylactoid reactions have been reported following first or subsequent administration of omalizumab (see Product Information). Patients should be monitored post-injection, and medications for the treatment of anaphylactic reactions should be available for immediate use following administration of omalizumab. Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.
27335	The application should indicate which formulation eg. pre-filled pen or pre-filled syringe to ensure appropriate item is approved.
27341	If a dose increase from tofacitinib 5mg twice daily to tofacitinib 10mg twice daily is required, tofacitinib 10mg may be authorised under the Balance of supply restriction to complete up to 24 weeks continuing treatment.
27355	If a dose increase from tofacitinib 5mg twice daily to tofacitinib 10mg twice daily is required, tofacitinib 10mg may be authorised under this restriction to complete up to 24 weeks continuing treatment.
27391	TREATMENT OF PAEDIATRIC PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) for paediatric patients with infliximab or adalimumab for moderate to severe ulcerative colitis; and infliximab for acute severe ulcerative colitis. Where the term 'biological medicine' appears in the following notes and restrictions, it refers to infliximab and adalimumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the 2 biological medicines at any one time.From 1 June 2017, under the PBS, all paediatric patients will be able to commence a treatment cycle where they may trial each PBS-subsidised biological medicine without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle and depending on the disease severity, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy. A patient who received PBS-subsidised biological medicine treatment prior to 1 June 2017 is considered to have started their treatment cycle as of 1 June 2017. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than twice. Once a patient has either failed or ceased to respond to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction.A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under the Initial 3 treatment restriction.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine therapy after 1 June 2017.(1) Initial treatment.Applications for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy - Initial 1 treatment (new patient); or,(ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate agent - Initial 2 treatment (Change or Recommencement of treatment after a break in biological medicine therapy of less than 5 years ) [further details are under 'Swapping treatment' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy with the same agent - Initial 2 treatment (Change or Recommencement of treatment after a break in therapy of less than 5 years ); or(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - recommencement of treatment after a break in biological medicine of more than 5 years).Treatment authorisations under Initial 1, Initial 2 and Initial 3 will be limited to provide for a maximum of 16 weeks of treatment for adalimumab and 14 weeks of treatment for infliximab. From 1 June 2017, a patient must be assessed for response to a course of initial PBS-subsidised treatment following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab, and this assessment must be conducted no later than 4 weeks from the date that course was ceased.(2) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment with that drug under the First continuing treatment and Subsequent continuing treatment restrictions providing they continue to sustain the response.For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment under the Initial 1, Initial 2 or Initial 3 treatment restrictions.For the second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(3) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. Paediatric Ulcerative Colitis Activity Index (PUCAI) Score, confirmation of ulcerative colitis disease), or the prior conventional therapies of corticosteroids or immunosuppressives.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving treatment (initial or continuing) at the time of the application. However, a patient cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug twice within the same treatment cycle. To ensure a patient receives the maximum treatment opportunities allowed under these swapping arrangements, it is important that they are assessed for response to every course of treatment.(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to recommence treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify under Initial 3 treatment restriction and meet the relevant criteria with respect to the indices of disease severity.
27392	An increase of number of repeats may be authorised up to 11 if the patient is receiving a weight based dosing of 3mg/kg every 2 weeks.
27500	Laboratory readings requested in this authority application must be no older than 52 weeks.
27501	In accordance with the dosing directions in the approved Product Information, the 10 mg presentation is not PBS listed for initiation of treatment.
27533	For dose titration involving the 100 mg or 150 mg strength, refer to the dose titration listing for these strengths with pack sizes of 14 units. Avoid prescribing a 'broken' quantity under this listing.
27544	Requests for increases in the maximum quantity (packs) up to 3 times that stated may be authorised.
27581	Pharmaceutical benefits that have the form adrenaline 1 mg/mL ampoules for injection in a pack size of 10 can be substituted for a pack size of 5 in the case of a shortage.
27588	Pharmaceutical benefits that have the brand BiResp Spiromax 200/6 powder for inhalation, 120 actuations, DuoResp Spiromax 200/6 powder for inhalation, 120 actuations and Symbicort Turbuhaler 200/6 powder for inhalation, 120 actuations are equivalent for the purposes of substitution.
27589	Pharmaceutical benefits that have the brand BiResp Spiromax 400/12 powder for inhalation, 2 x 60 actuations, DuoResp Spiromax 400/12 powder for inhalation, 2 x 60 actuations and Symbicort Turbuhaler 400/12 powder for inhalation, 2 x 60 actuations are equivalent for the purposes of substitution.
27614	TREATMENT OF COMPLEX REFRACTORY FISTULISING CROHN DISEASEThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for patients with complex refractory fistulising Crohn disease. Where the term 'biological medicine' appears in the following notes and restrictions, it refers to adalimumab and infliximab only.A patient is eligible for PBS-subsidised treatment with only 1 of the PBS-subsidised biological medicines for this condition at any one time.From 1 April 2011, under the PBS, all patients will be able to commence a treatment cycle where they may trial PBS-subsidised adalimumab or infliximab without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with adalimumab or infliximab while they continue to show a response to therapy.A patient who received PBS-subsidised adalimumab or infliximab treatment prior to 1 April 2011 is considered to have started their treatment cycle as of 1 April 2011.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised adalimumab or infliximab more than twice.Once a patient has either failed or ceased to respond to treatment for this condition 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy for this condition before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised adalimumab or infliximab treatment in the most recent cycle to the date of the first application for initial treatment with adalimumab or infliximab under the new treatment cycle.A patient who has failed fewer than 3 trials of biological medicine therapy in a treatment cycle and who has a break in therapy of less than 5 years, may commence a further course of treatment within the same treatment cycle.A patient who has failed 3 trials or fewer of biological medicine therapy in a treatment cycle and who has a break in therapy of more than 5 years, may commence a new treatment cycle.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.(1) How to prescribe PBS-subsidised adalimumab or infliximab therapy after 1 April 2011.(a) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised adalimumab or infliximab therapy in this treatment cycle and wishes to commence such therapy (Initial 1- new patient or recommencement of treatment after a break in biological medicine of more than 5 years); or(ii) a patient has received prior PBS-subsidised (initial or continuing) adalimumab or infliximab therapy and wishes to trial an alternate agent (Initial 2 - change or recommencement of treatment after a break in biological medicine of less than 5 years) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with adalimumab or infliximab following a break in PBS-subsidised therapy with that agent (Initial 2 - change or recommencement of treatment after a break in biological medicine of less than 5 years).Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy for adalimumab and 14 weeks of therapy for infliximab.From 1 April 2011, a patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab, and this assessment must be conducted no later than 4 weeks from the date that course was ceased.Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(b) Continuing treatment.Following the completion of an initial treatment course with a biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment under the Initial 1, or Initial 2 treatment restrictions.For the second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap if eligible to the alternate biological medicine within the same treatment cycle.A patient may trial the alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with adalimumab or infliximab at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug two times within the same treatment cycle.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment within the timeframes specified in the relevant restriction.A patient who is not able to complete an initial treatment course for a biological medicine will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(3) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements submitted with the first authority application for adalimumab or infliximab. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to recommence treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity.
27622	Requests seeking an increased maximum quantity (packs) up to 4 times that stated, may be authorised.
27644	TREATMENT OF ADULT PATIENTS WITH SEVERE CHRONIC PLAQUE PSORIASISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines adalimumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab for adult patients with severe chronic plaque psoriasis. Therefore, where the term 'biological medicines' appears in notes and restrictions, it refers to adalimumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.A patient who received PBS-subsidised adalimumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab treatment prior to 1 February 2019 is considered to start their first cycle as of 1 February 2019.A patient receiving PBS-subsidised treatment for chronic plaque psoriasis is able to commence a 'treatment cycle', where they may trial biological medicines without having to experience a disease flare, when swapping to an alternate biological medicine. Under these arrangements, within a single cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.A patient must be assessed for response to each course of treatment according to the criteria included in the relevant continuing treatment restriction.Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle.The duration of the break in therapy will be measured from the date the last prescription for PBS-subsidised treatment was approved in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under Initial 3 treatment restriction.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under Initial 2 treatment restriction.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine treatment for severe chronic plaque psoriasis.There are separate restrictions for both the initial and continuing treatment for psoriasis affecting the whole body, versus psoriasis affecting the face, hands and feet.(1) Initial treatment.An application for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised biological medicine treatment for this condition and wishes to commence such therapy (Initial 1 - New patient); or(ii) a patient who has received prior PBS-subsidised biological medicine therapy for this condition (initial or continuing) and wishes to trial an alternate biological medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years) [further details are under (4) 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years).(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years).An application for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, etanercept, ixekizumab, and secukinumab, 20 weeks of therapy for guselkumab, 22 weeks of therapy for infliximab and 28 weeks of therapy for risankizumab, tildrakizumab and ustekinumab.It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of their course of initial treatment to ensure uninterrupted biological medicine supply.(2) Assessment of response to initial treatment.When prescribing initial treatment with a biological medicine, it is recommended that a PASI assessment is conducted after at least 12 weeks of treatment and no later than 4 weeks from the completion of this initial treatment course.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.(3) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not submitted where applicable, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Infliximab, adalimumab and etanercept only:For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy under the Initial 1 or Initial 2 treatment restrictions.For second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(4) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (i.e. a PASI score of greater than 15), or the prior non-biological therapy requirements, except if the patient has had a break in therapy of more than 5 years who would need to requalify with respect to the indices of disease severity.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that particular biological medicine within the same cycle or have experienced treatment failure with that particular biological medicine that required permanent treatment withdrawal.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.(5) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline PASI assessment submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline PASI assessments any time that an initial or change or recommencement treatment application is submitted within a treatment cycle and this revised baseline PASI score will be used to assess the patient's response to the PBS-subsidised treatment.To ensure consistency in determining response, the same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of all continuing treatments.(6) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological therapy of at least 5 years, must qualify under Initial 3 treatment according to the criteria of the relevant restriction and index of disease severity. A PASI assessment must be conducted prior to application and patient must have a PASI score of greater than 15 for whole body. For the face, hand, foot at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or the skin area affected is 30% or more of the face, palm of a hand or sole of a foot. The PASI assessment must be no older than 4 weeks at the time of application.
27656	This product is not PBS-subsidised for the treatment of previously untreated CD30 positive cutaneous T-cell lymphoma.
27681	TREATMENT OF PATIENTS WITH SEVERE ACTIVE JUVENILE IDIOPATHIC ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and tocilizumab for a patient who has severe active juvenile idiopathic arthritis. Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, etanercept and tocilizumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the 3 biological medicines at any one time.From 1 April 2014, a patient receiving PBS-subsidised biological medicine is considered to be in a treatment cycle where they may swap to an alternate biological medicine without having to experience a disease flare. Under these interchangeability arrangements, within a single treatment cycle, a patient may:(i) continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy; and(ii) fail to respond or to sustain a response to each PBS-subsidised biological medicine once only. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 12 month break in PBS-subsidised biological medicine therapy before they are eligible to commence another cycle.The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised biological medicine was approved to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.A patient who received PBS-subsidised biological medicine immediately prior to 1 April 2014 is considered to be in their first cycle as of 1 April 2014. A patient who has had a break in biological medicine treatment of at least 12 months immediately prior to making a new application, on or after 1 April 2014, will commence a new treatment cycle under the Initial 3 treatment restriction.A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 12 months may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction.A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 12 months must commence a new treatment cycle under the Initial 3 treatment restriction.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine treatment therapy after 1 April 2014.(1) Initial treatment.Applications for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient); or(ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine therapy of less than 12 months) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 12 months with the same medicine (initial 2 - Change or Recommencement of treatment after a break in biological medicine therapy of less than 12 months).(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 12 months (initial 3 - Recommencement of treatment after a break in biological medicine of more than 12 months)Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy.A patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.(2) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.It is recommended that a patient be reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Adalimumab and infliximab only:Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response.It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(3) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (joint count) or the prior non-biological medicine therapy requirements, except if the patient has had a break in therapy of more than 12 months who would then need to requalify under the initial 3 restrictions with respect to the indices of disease severity.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application.However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.To ensure a patient receives the maximum treatment opportunities allowed under the interchangeability arrangements, it is important that they are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction.To avoid confusion, an application for a patient who wishes to swap to an alternate biological medicine should be accompanied by the approved authority prescription or remaining repeats for the biological medicine the patient is ceasing.(4) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the joint count submitted with the first authority application for a biological medicine. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to the revised baseline measurement.(5) Recommencement of treatment after a 12 months break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological medicine therapy of at least 12 months, must qualify under the initial 3 restriction and meet the relevant criteria and index of disease severity.(6) Withdrawal of treatment after sustained remission.Withdrawal of treatment with biological medicine should be considered in a patient who has achieved and sustained complete remission of disease for 12 months. An assessment of demonstration of response to the current treatment should be conducted at the time treatment is ceased and the results retained in the patient's records. These results must be submitted to Services Australia if subsequent authority applications are required.
27698	Authority applications to continue treatment after this application should occur under the 'Subsequent continuing treatment' phase.
27706	TREATMENT OF ADULT PATIENTS WITH A HISTORY OF JUVENILE IDIOPATHIC ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and tocilizumab for a patient over 18 years who has a history of juvenile idiopathic arthritis with onset prior to the age of 18 years. Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, etanercept and tocilizumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the 3 biological medicines at any one time.From 1 April 2014, a patient receiving PBS-subsidised biological medicine therapy is considered to be in a treatment cycle where they may swap to an alternate biological medicine without having to experience a disease flare. Under these interchangeability arrangements, within a single treatment cycle, a patient may:(i) continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy; and(ii) fail to respond or to sustain a response to each PBS-subsidised biological medicine once only. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single treatment cycle and they must have, at a minimum, a 5 year break in PBS-subsidised biological medicine therapy before they are eligible to receive further PBS-subsidised biological medicine therapy.The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised biological medicine was approved to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.A patient who received PBS-subsidised biological medicine treatment immediately prior to 1 April 2014 is considered to be in their first cycle as of 1 April 2014. A patient who has had a break in biological medicine treatment of at least 24 months immediately prior to making a new application, on or after 1 April 2014, will commence a new treatment cycle under the Initial 3 treatment restrictionA patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of less than 24 months may commence a further course of treatment within the same treatment cycle under the Initial 2 treatment restriction.A patient who has failed fewer than 3 trials of a biological medicine in a treatment cycle and who has a break in therapy of more than 24 months must commence a new treatment cycle under the Initial 3 treatment restriction.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine therapy after 1 April 2014.(1) Initial treatment.Applications for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient); or(ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine of less than 24 months) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 24 months with the same medicine (Initial 2 - Change or recommencement of treatment after a break in biological medicine therapy of less than 24 months); or(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 24 months (Initial 3 - recommencement of treatment after a break in biological medicine of more than 24 months).Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy.A patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.(2) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.It is recommended that a patient be reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Adalimumab and infliximab only:Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response.It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(3) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (joint count and ESR/CRP) or the prior non-biological medicine therapy requirements, except if the patient has had a break in therapy of more than 24 months who would then need to requalify under the Initial 3 restrictions with respect to the indices of disease severity.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.To ensure a patient receives the maximum treatment opportunities allowed under the interchangeability arrangements, it is important that they are assessed for response to every course of treatment approved, within the timeframes specified in the relevant restriction.(4) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the joint count submitted with the first authority application for a biological medicine. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.(5) Recommencement of treatment after 24 months break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological medicine therapy of at least 24 months, must qualify under the Initial 3 restriction and meet the relevant criteria and index of disease severity.
27712	TREATMENT OF ADULT PATIENTS WITH SEVERE CROHN DISEASEThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for adult patients with severe Crohn disease. Where the term 'biological medicine' appears in the following notes and restrictions, it refers to the tumour necrosis factor (TNF) alfa-antagonists (adalimumab and infliximab), the alpha-4 beta-7 integrin inhibitor (vedolizumab) and the human IgG1kappa monoclonal antibody (ustekinumab).Patients are eligible for PBS-subsidised treatment with only 1 of the above PBS-subsidised biological medicines at any one time.From 1 September 2017, under the PBS, all patients will be able to commence a treatment cycle where they may trial PBS-subsidised a biological medicine without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy.A patient who received PBS-subsidised treatment with a biological medicine prior to 1 September 2017 is considered to have started their treatment cycle as of 1 September 2017.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.Once a patient has either failed or ceased to respond to treatment for this condition 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy for this condition before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last approval for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.A patient who has failed fewer than 3 trials of biological medicine therapy in a treatment cycle and who has a break in therapy of less than 5 years, may commence a further course of treatment within the same treatment cycle.A patient who has failed fewer than 3 trials of biological medicine therapy in a treatment cycle and who has a break in therapy of more than 5 years, may commence a new treatment cycle.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.(1) How to prescribe PBS-subsidised adalimumab, infliximab, vedolizumab or ustekinumab therapy after 1 September 2017.(a) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised biological medicine treatment in this treatment cycle and wishes to commence such therapy Initial 1 (new patient); or(ii) a patient has received prior PBS-subsidised (initial or continuing) biological medicine and wishes to trial an alternate agent - Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy with that agent - Initial 2 (change or recommencement of treatment after a break in therapy of less than 5 years); or(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years).From 1 September 2017, a patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and no later than 4 weeks from the date that course was ceased for adalimumab or infliximab subcutaneous form or ustekinumab or vedolizumab subcutaneous form, and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab intravenous form or vedolizumab intravenous form.Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Infliximab subcutaneous form only:Initial treatment to subcutaneous form of infliximab should be permitted after administration of at least 2 initial intravenous infusions of infliximab. A maximum quantity and number of repeats to provide for weeks 6, 8, 10, 12, 14 and 16 will be authorised.Ustekinumab only: Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 2 vials of 45 mg and no repeats.Vedolizumab subcutaneous form only: initial treatment to subcutaneous form of vedolizumab should be permitted after administration of at least 2 of the 3 initial intravenous infusions of vedolizumab. Where two initial doses of vedolizumab (at weeks 0 and 2) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. A maximum quantity and number of repeats to provide for weeks 6, 8, 10, 12, 14 and 16 will be authorised. Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity to provide for weeks 14 and 16 will be authorised.(b) Continuing treatment.Following the completion of an initial treatment course with a biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.It is recommended that a patient be reviewed in the 4 weeks prior to completing their current course of treatment to ensure uninterrupted supply of treatment.A patient must be assessed for response to a course of continuing therapy, and the assessment must be conducted within 4 weeks of the last dose. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Infliximab patients:A patient may swap between the intravenous and subcutaneous forms of infliximab at any time under the continuing treatment restrictions provided the patient has demonstrated adequate response to treatment with infliximab.Vedolizumab patients:A patient may swap between intravenous and subcutaneous forms of vedolizumab at any time under the continuing treatment restrictions provided the patient has demonstrated adequate response to treatment with vedolizumab.Adalimumab and infliximab intravenous form only:Following the completion of an initial treatment course with a specific biological medicine, a patient remains eligible to receive up to 24 weeks per course of continuing treatment under the First continuing treatment and Subsequent continuing treatment restrictions with that drug providing they continue to sustain the response.It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine therapy is approved, a patient may swap if eligible to the alternate biological medicine within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. Crohn Disease Activity Index (CDAI) Score, confirmation of Crohn disease), or the prior conventional therapies of corticosteroid therapy and immunosuppressive therapy.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug once within the same treatment cycle.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment, within the timeframes specified in the relevant restriction.A patient who is not able to complete an initial treatment course for a biological medicine will be deemed to have failed treatment with thatbiological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(3) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the CDAI or evidence of intestinal inflammation submitted with the first authority application for a biological medicine.However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used to assess response to all subsequent treatments.(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to recommence treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity under the Initial 3 restriction. A re-trial of systemic therapy is not required.
27713	The intent of this listing is to provide doses at weeks 0, 1 and 2. For treatment at week 4 and beyond, see the 'Continuing treatment' listing.
27741	Authority approval for an increased maximum quantity, up to 3 times the stated quantity (in packs), may be sought.
27773	The Oxford scale, modified Oxford scale and Ocular Surface Disease Index (OSDI) were relied upon in the submission supporting initial PBS listing.The Oxford scale uses a chart system consisting of a series of panels, labelled A to E in order of increasing severity. In each chart, staining is represented by dots. To grade staining, comparisons are made between the panels and the appearance of staining on the exposed interpalpebral conjunctiva and cornea of the patient. The details of the chart are presented in Figure 1 and, in a simplified form in Figure 4 (where the criteria, dot count and log columns are not displayed), in the following literature article: Bron A, Evans V, Smith, J. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003;22(7):640-650.The modified Oxford scale is as above, but with the first grade depiction (Grade 0), termed 'Grade 0.5'.A list of equivalent scales to the Oxford scale is not provided. Prescribers should be satisfied that a scale other than the Oxford scale, if used, is equivalent to the Oxford scale.The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire created by the Outcomes Research Group at Allergan Inc, Irvine, CA, USA, to assess dry eye symptoms and the effects on vision-related function.The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to 'none of the time' and 4 corresponding to 'all of the time'. A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.The OSDI questionnaire asks the following:Presence of ocular symptoms - Have you experienced any of the following during the last week?1. Eyes that are sensitive to light2. Eyes that feel gritty3. Painful or sore eyes4. Blurred vision5. Poor visionImpact on daily activities - Have you had problems with your eyes limited you in performing any of the following during the last week?1. Reading2. Driving at night3. Working with a computer or bank machine (ATM)4. Watching TVEnvironmental factors - Have your eyes felt uncomfortable in any of the following situations during the last week?1. Windy conditions2. Places or areas with low humidity (very dry)3. Areas that are airconditionedRate responses on a scale of 0 to 4; 0 = none of the time, 1 = some of the time, 2 = half of the time, 3 = most of the time, and 4 = all of the time.Further information on this index is in the following literature article: Walt J, Rowe M, Stern K. Evaluating the functional impact of dry eye: the Ocular Surface Disease Index. Drug Information Journal. 1997;31:1436The 'Dry Eye OSDI 'Questionnaire' app developed by Allergan Inc is available to download for iPhone.
27774	If the maximum number of repeats stated in this listing is not requested in this application, further supplies can be obtained through this treatment phase listing to continue treatment for up to the first 180 days of treatment, but the OSDI score and CFS grade need not be re-stated. Alternatively, treatment may be continued under the 'Continuing treatment' phase listing, provided the patient meets all eligibility criteria specified in that treatment phase listing.
27801	Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors for the purposes of this restriction are abemaciclib, palbociclib and ribociclib.
27834	TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE PSORIATIC ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, tofacitinib, upadacitinib and ustekinumab for adult patients with severe active psoriatic arthritis. Therefore, where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, tofacitinib, upadacitinib and ustekinumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.A patient receiving PBS-subsidised treatment for psoriatic arthritis is able to commence a treatment cycle where they may trial biological medicines without having to experience a disease flare when swapping to the alternate biological medicine. Under these arrangements, within a single cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.A patient who received PBS-subsidised adalimumab, certolizumab pegol, etanercept, golimumab, guselkumab, infliximab, ixekizumab, secukinumab, tofacitinib or ustekinumab treatment prior to 1 October 2021 is considered to start their first cycle as of 1 October 2021.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a single cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence another cycle [further details are under '(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy' below].The duration of the break in therapy will be measured from the date the last prescription for PBS-subsidised treatment was approved in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under Initial 3 treatment restriction.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under Initial 2 treatment restriction.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine treatment for severe active psoriatic arthritis.(1) Initial treatment.Applications for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised biological medicine treatment and wishes to commence such therapy (Initial 1 - New patient); or(ii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years).(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years) orAn application for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, etanercept, golimumab secukinumab, tofacitinib and upadacitinib, 18 to 20 weeks of therapy for certolizumab pegol (depending upon the dosing regimen), 20 weeks of therapy for guselkumab or ixekizumab, 22 weeks of therapy for infliximab, and 28 weeks of therapy for ustekinumab. It is recommended that a patient be reviewed in the 4 weeks prior to completing their course of initial treatment to ensure uninterrupted biological medicine supply.A patient must be assessed for response to a course of PBS-subsidised initial treatment following a minimum of 12 weeks of therapy and conducted no later than 4 weeks from the cessation of the treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment.(2) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed for response following a minimum of 12 weeks of therapy and no later than the 4 weeks from the completion of the most recent course of treatment.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not submitted where applicable, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Infliximab, adalimumab and etanercept only:For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment under the Initial 1, Initial 2 or Initial 3 treatment restrictions.For the second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(3) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to re-qualify with respect to either the indices of disease severity (i.e. erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level, and active joint count) or the prior non-biological therapy requirements, except if the patient has had a break in therapy of more than 5 years who would need to requalify under the Initial 3 treatment restriction with respect to the indices of disease severity.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application.However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.Within a treatment cycle a patient may alternate between therapy with any biological medicine of their choice (1 at a time) providing:(i) they have not received PBS-subsidised treatment with that particular biological medicine previously; or(ii) they have demonstrated an adequate response to that particular biological medicine if they have previously trialled it on the PBS; and(iii) they have not previously failed to respond to treatment 3 times in this treatment cycle with biological medicines.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.(4) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the indices of disease severity submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements any time that an initial or change or recommencement treatment application is submitted within a treatment cycle and these revised baseline measurements will be used to assess response to the PBS-subsidised treatment.To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. Therefore, where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be used to determine response. Similarly, where the baseline active joint count is based on total active joints (i.e. 20 or more active joints), response will be determined according to a reduction in the total number of active joints.(5) Re-commencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent course of treatment following a break in PBS-subsidised biological therapy of at least 5 years, must qualify under Initial 3 treatment restriction according to the criteria of the relevant restriction and index of disease severity. The application must include a joint count and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.
27852	TREATMENT OF PATIENTS UNDER 18 YEARS WITH SEVERE CHRONIC PLAQUE PSORIASISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines etanercept and ustekinumab for patients under 18 years of with severe chronic plaque psoriasis. Therefore, where the term 'biological medicines' appears in notes and restrictions, it refers to etanercept and ustekinumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.A patient who is receiving PBS-subsidised treatment for severe chronic plaque psoriasis is able to commence a treatment cycle where they may trial a biological medicine without having to experience a disease flare when swapping to an alternate biological medicine within the same treatment cycle.Under these arrangements, within a treatment cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than twice.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.A patient must be assessed for response to each course of treatment according to the criteria included in the relevant continuing treatment restriction.Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle.The duration of the break in therapy will be measured from the date the last prescription for PBS-subsidised treatment was approved in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.A patient who has failed fewer than 3 times in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under Initial 3 treatment restriction.A patient who has failed fewer than 3 times in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under Initial 2 treatment restriction.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.There are separate restrictions for the initial and continuing treatment for psoriasis affecting the whole body, versus psoriasis affecting the face, hand and foot.How to prescribe PBS-subsidised biological medicine treatment for severe chronic plaque psoriasis.(i) a patient has never received PBS-subsidised biological medicine treatment for this condition and wishes to commence such therapy (Initial 1 - Biological medicine-naive patient); or(ii) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years); or(iii) a patient who has received prior PBS-subsidised biological medicine therapy for this condition (initial or continuing) and wishes to trial an alternate biological medicine or recommence with the same biological medicine within the same treatment cycle (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years) [further details are under (4) 'Swapping therapy' below]; or(iv) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years).Etanercept only:After completing 24-weeks of treatment with PBS-subsidised etanercept, a patient is eligible for re-treatment with etanercept within 12 months (Initial 3) due to a disease flare with psoriasis affecting the whole body if:(i) there is at least a 50% change in the patients PASI score compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept; or(ii) the patient has a current PASI score greater than 15Etanercept only:After completing 24-weeks of treatment with PBS-subsidised etanercept, a patient is eligible for re-treatment with etanercept (Initial 3 ) due to a disease flare with psoriasis affecting the face, hand or foot if:(i) all subscores are rated moderate to severe; or(ii) 2 of the three subscores are rated severe to very severe; or(iii) the affected area of skin has increased by at least 50% compared to that at the time of the last assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept; or(iv) the area affected is 30% or more of the face, palm of a hand or sole of a foot,(2) Assessment of response to initial treatment.After prescribing initial treatment with a biological medicine, a PASI assessment must be conducted after at least 12 weeks of treatment. This assessmentwill be used to determine eligibility for continuing treatment. and must be conducted within 8 weeks of thelast administered dose.To avoid an interruption of supply for continuing treatment, the assessment should be submitted and no later than 2 weeks prior to when the next dose (under the new authority application) is due, unless the patient is currently on a treatment break.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.(3) Continuing treatmentEtanercept only:Following the completion of an initial 16-week treatment course with etanercept, a patient may receive a further 8 weeks of treatment (under the 'Completion of course' treatment phase) to complete a 24-week treatment course, providing they have demonstrated an adequate response to treatment to the initial supply.Ustekinumab only:Following the completion of an initial 28-week treatment course, a patient may qualify to receive up to 24 weeks per continuing treatment course provided they demonstrate an adequate response to treatment. The patient remains eligible to receive continuing treatment in courses of up to 24 weeks provided they continue to sustain the response. It is recommended that a patient be reviewed 4 weeks prior to when their next dose (under a new authority application) is due to ensure uninterrupted supply, but no later than 8 weeks after the date of the last administered dose.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not submitted where applicable, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(4) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (i.e. a PASI score of greater than 15), or the prior non-biological therapy requirements. If the patient has had a break in therapy of more than 5 years, the indices of disease severity need to be met, but a re-trial of non-biological therapy is not required.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to that biological medicine twice within the same treatment cycle or have failed to respond to biological medicines, as an aggregate, on 3 occasions within the same treatment cycle.To ensure patients receive the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.(5) Baseline measurements to determine response.A response to treatment must be demonstrated based on the baseline PASI assessment submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline PASI assessments any time that an initial or change or recommencement treatment application is submitted within a treatment cycle and this revised baseline PASI score will be used to assess the patient's response to the PBS-subsidised treatment.To ensure consistency in determining response, the same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of all continuing treatments.(6A) Re-commencement of treatment after a break of less than 5 years in PBS-subsidised therapy (all drugs except etanercept).A patient who wishes to resume treatment following a break in PBS-subsidised therapy of less than 5 years must resume under the 'Initial 2' treatment phase. The most recent PASI assessment demonstrating disease flare must be no more than 4 weeks old at the time of application.(6B) Re-treatment (etanercept only)A patient may be re-treated, in certain circumstances, with etanercept after completing a 24-week treatment course under the 'Initial 4' treatment phase.(7) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to undertake a new treatment cycle following a break in PBS-subsidised biological therapy of at least 5 years, must qualify under an 'Initial 3' treatment phase.
27872	To complete a 24-week course of treatment beyond this authority application, the next authority application (apart from supplies obtained under 'Balance of Supply') is to be under the 'completion of course' treatment phase.Therefore, remind the patient to return for clinical review in approximately 12 weeks to enable ample time to obtain the final 8 weeks of treatment of a 24-week treatment course.Document the patient's baseline disease severity indices scores in their medical record, in addition to stating them in this authority application, to ensure:(i) the patient's response to treatment can be quantified from week 12; and(ii) in the event that the patient's treating clinician changes, the baseline value(s) are available to the new clinician without need to refer to a third party.
27887	Aim to conduct and submit the PASI assessment at week 12 or soon after to ensure uninterrupted supply.
27892	Aim to conduct and submit the PASI/percentage of skin area affected assessment at week 12 or soon after to ensure uninterrupted supply.
27893	The 28-weeks of treatment provided by this listing is intended to cover doses occurring at week 0, week 4 and week 16. Based on body weight, request an amount of biological medicine sufficient to cover a dose occurring at these timepoints. The original prescription is intended to cover a dose at week 0 and the 2 repeat prescriptions available are intended to cover doses at week 4 and week 16.The dose due at week 28 is obtained with the first prescription obtained under the 'Continuing treatment' phase. Remind the patient to return for clinical review at approximately week 24 of treatment to enable ample time to obtain the authority application enabling dosing from week 28 and onwards.Document the patient's baseline disease severity indices scores in their medical record, in addition to stating them in this authority application, to ensure:(i) the patient's response to treatment can be quantified; and(ii) in the event that the patient's treating clinician changes, the baseline value(s) are available to the new clinician without need to refer to a third party.
27898	For the next authority approval following this one, aim to conduct and submit the PASI assessment at approximately 4 weeks prior to when a new authority application is due to ensure uninterrupted supply.
27908	A Grandfathered patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria.
27943	This grandfather restriction will cease to operate from 3 months after the date specified in the clinical criteria.
27977	The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for adults with severe active rheumatoid arthritis. This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.The term biological medicine refers to the tumour necrosis factor (TNF) alfa antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), the chimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-6 inhibitor (tocilizumab), the T-cell co-stimulation modulator (abatacept) and the Janus kinase (JAK) inhibitors (baricitinib, tofacitinib, upadacitinib).Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant 'First continuing - critical shortage of tocilizumab' PBS listing.
27980	The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for adults with severe active rheumatoid arthritis.This PBS listings is a temporary listing and may only be used when an application for initial supply of this medicine has been made under Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab).
27990	Pharmaceutical benefits that have the brand Actemra 200 mg injection in a pack size of 1 and pharmaceutical benefits that have the brand RoActemra 200 mg injection in a pack size of 1 or a pack size of 4 are equivalent for the purposes of substitution in the case of a shortage.
27991	Pharmaceutical benefits that have the brand Actemra 400 mg injection in a pack size of 1 and pharmaceutical benefits that have the brand RoActemra 400 mg injection in a pack size of 1 or a pack size of 4 are equivalent for the purposes of substitution in the case of a shortage.
27992	Pharmaceutical benefits that have the brand Actemra 80 mg injection in a pack size of 1 and pharmaceutical benefits that have the brand RoActemra 80 mg injection in a pack size of 1 or a pack size of 4 are equivalent for the purposes of substitution in the case of a shortage.
27999	TREATMENT OF ADULT PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of secukinumab, certolizumab pegol and golimumab for adult patients with non-radiographic axial spondyloarthritis.Where the term 'biological medicine' appears in notes and restrictions, it refers to secukinumab, certolizumab pegol and golimumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the 3 biological medicines at any one time.Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy.A serious adverse reaction requiring permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.Once a patient has either failed or ceased to respond to treatment 3 times (once with any biological medicine) within the same treatment cycle, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last prescription for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.A patient who has failed fewer than 3 trials of biological medicine therapy in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle.A patient who has failed 3 trials or fewer of biological medicine therapy in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine treatment with secukinumab, certolizumab pegol and golimumab(1) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised biological medicine treatment in this treatment cycle and wishes to commence such therapy (Initial 1 - New patient)(ii) a patient has received prior PBS-subsidised (initial or continuing) biological medicine therapy and wishes to trial an alternate agent (Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same agent (Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years); or(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years).A patient must be assessed for response to a course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy.(2) Continuing treatment.For continuing courses of PBS-subsidised biological medicine it is recommended that a patient be reviewed the month prior to completing their current course of treatment to ensure uninterrupted biological medicine supply.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that biological medicine provided they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment in courses of up to 24 weeks provided they continue to sustain an adequate response.A patient must be assessed for response to a course of continuing therapy, and the assessment must be conducted no later than 4 weeks from the cessation of that treatment course. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction requiring permanent treatment withdrawal.(3) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. the C-reactive protein (CRP) level and the BASDAI score), or the prior NSAID therapy and exercise program requirements.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction requiring permanent treatment withdrawal.(4) Baseline measurements to determine response.A response to treatment is based on the baseline BASDAI score and CRP level documented in the patient's medical records.For a new patient, the BASDAI score used to determine baseline disease severity must be measured while the patient is receiving NSAID therapy and completing their exercise program.To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications.Prescribers may provide new baseline measurements any time that an 'Initial treatment' authority application is submitted and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.(5) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent course of treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must qualify under the Initial 3 treatment restriction. The same clinical criteria and indices of disease severity (i.e. the C-reactive protein (CRP) levels and the BASDAI) as for the Initial 1 (New patient) restriction will need to be met, but a re-trial of NSAID therapy and exercise therapy is not required.
28006	The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients who have severe active juvenile idiopathic arthritis.This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.Alternative biological medicine refers to adalimumab and etanercept.Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant 'First continuing - Temporary listing' PBS listing.
28007	The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab and etanercept for a patient who has severe active juvenile idiopathic arthritis.This PBS listings is a temporary listing and may only be used when an application for initial supply of this medicine has been made under Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab).
28008	The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, and etanercept for patients over 18 years who have a history of juvenile idiopathic arthritis with onset prior to the age of 18 years.This listing is a temporary listing and is only to be used to transfer patients currently receiving PBS-subsidised treatment with tocilizumab to another biological medicine, where tocilizumab is not available due to the current critical medicines shortage.Alternative biological medicine refers to adalimumab and etanercept.Should it be necessary to continue treatment with the alternative biological medicine, applications must be made under the relevant 'First continuing - Temporary listing' PBS listing.
28009	The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab and etanercept for a patient over 18 years who has a history of juvenile idiopathic arthritis with onset prior to the age of 18 years. Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, etanercept and tocilizumab only.This PBS listings is a temporary listing and may only be used when an application for initial supply of this medicine has been made under Initial 4 (Temporary listing - change of treatment due to critical shortage of tocilizumab).
28024	The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines for adults with severe active rheumatoid arthritis. This listing is a temporary listing and is only to be used to transfer patients back to tocilizumab from another biological medicine, where treatment was changed due to unavailability of tocilizumab due to the critical medicines shortage.The term biological medicine refers to the tumour necrosis factor (TNF) alfa antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), the chimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-6 inhibitor (tocilizumab), the T-cell co-stimulation modulator (abatacept) and the Janus kinase (JAK) inhibitors (baricitinib, tofacitinib, upadacitinib).
28086	Currently PBS-listed drugs with the indication of: 'metastatic or unresectable malignant gastrointestinal stromal tumour' are: imatinib and sunitinib
28088	Pharmaceutical benefits that have the form follitropin alfa cartridge (Ovaleap) and pharmaceutical benefits that have the form follitropin alfa single pen device (Gonal-f Pen), in the same corresponding strength, are equivalent for the purposes of substitution.Where the Ovaleap brand is supplied, the separate pen device is to be supplied to the patient where required as it is not packaged with the cartridges. The pen device for the Ovaleap brand can be obtained by contacting the pharmaceutical wholesaler, or, the sponsor directly.
28245	The Eczema Area and Severity Index (EASI) referenced in this restriction is that described in the following literature publications:Chalmers JR et al. Report from the third international consensus meeting to harmonise core outcome measures for atopic eczema/dermatitis clinical trials (HOME). British Journal of Dermatology 2014 December;171(6):1318-25.Schmitt J et al. HOME initiative collaborators. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. The Journal of Allergy and Clinical Immunology 2014 October;134(4):800-7
28246	The Physician's Global Assessment (5-point scale) referenced in this restriction is that described in the following literature publication:Fatumura M et al. Journal of the American Academy of Dermatology 2016; 64(2): 288-94The overall appearance of dermatitis lesions is rated as 4 (severe) if the lesions are best described as featuring: deep/dark red erythema, with marked and extensive induration/papulation; excoriation and oozing/crusting are present.
28247	Dose changes subsequent to this authority application, whether they occur during an initial treatment or continuing treatment phase, may occur under the 'Dose change' treatment phase listing.
28301	Current Medicare Benefits Schedule item numbers for extracorporeal photopheresis for the treatment of chronic graft-versus host disease are: 13761 and 13762.
28302	A new treatment episode is considered to have begun when treatment with this drug/extracorporeal photopheresis follows a relapse of the condition. There is no limit on the number of new treatment cycles that may be commenced, but re-treatment following a relapse must not commence under 'Continuing treatment'.
28316	A maximum quantity (vials) of 12 with 1 repeat prescription provides 24 doses of this drug. An additional 25th dose can be prescribed under this treatment phase by issuance of a further prescription made out for one vial with nil repeats. Alternatively, the 25th dose can be sought under the 'Continuing treatment' restriction. The 26th dose and onwards must be requested under the 'Continuing treatment' restriction.
28323	Up to 2 additional repeats to that stated in this listing may be sought.
28339	For the purposes of administering this restriction, current Bruton's tyrosine kinase inhibitors are: acalabrutinib, ibrutinib, zanubrutinib
28384	Interstitial lung disease includes, but is not limited to:(i) connective tissue associated interstitial lung disease;(ii) chronic fibrosing hypersensitivity pneumonitis;(iii) idiopathic non-specific interstitial pneumonia;(iv) pulmonary sarcoidosis.
28439	Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a 'Grandfathered' patient must qualify under the 'First Continuing Treatment' criteria.
28440	This grandfather restriction will cease to operate from 5 years after the date specified in the clinical criteria.
28449	Patients may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a 'Balance of Supply' patient must qualify under the 'First Continuing Treatment' criteria.
28450	This Balance of Supply restriction will cease to operate from 5 years after the date specified in the clinical criteria.
28482	TREATMENT OF PATIENTS WITH CHRONIC MYELOID LEUKAEMIA - FIRST-LINE THERAPYThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for the chronic phase of chronic myeloid leukaemia (CML) in the first line treatment setting.Where the term TKI agent appears in the following notes and restrictions it refers to imatinib mesilate, dasatinib or nilotinib.Patients are eligible for PBS-subsidised treatment with only one TKI agent at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between TKI agents if they have not failed prior PBS-subsidised treatment with that agent.1. Initial First-line treatmentA patient will be able to be prescribed any of imatinib mesilate, dasatinib or nilotinib within the initial 18 month treatment period, as long as only one agent is used at a time and providing the patient has not failed to respond to any one of these TKIs.During the initial 18 month treatment period, switching between approved first-line agents may only occur for reasons of intolerance, not failure to respond.2. Continuing First-line treatmentPatients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% on the international scale (Blood 108:28-37,2006) to receive continuing therapy.For continuing applications patients must demonstrate a response to PBS-subsidised treatment and a pathology report demonstrating the patient has responded to the initial course of treatment must be documented in the patient's medical records.During continuing therapy beyond the initial 18 month treatment period, switching between approved first-line agents may only occur for reason of intolerance. Where there is failure to respond, switching may only occur through application for prescription of second-line agents.Where a patient has previously received PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib no approval will be granted for PBS-subsidised re-treatment in the chronic phase of chronic myeloid leukaemia, where that patient has at any time failed to meet the response criteria whilst on that TKI agent.3. Authority approval requirementsResponse criteria to initial first-line treatment with imatinib mesilate, dasatinib or nilotinib: For the purposes of assessing response to PBS-subsidised treatment with imatinib mesilate, dasatinib or nilotinib either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted and the results must be documented in the patient's medical records. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted and the results must be documented in the patient's medical records. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted and the results must be documented in the patient's medical records within 18 months of the commencement of treatment with imatinib, dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent).4. Definitions of responseA major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells. A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response.5. Definitions of loss of responseLoss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.
28496	Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
28500	Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
28501	Authority applications for increased quantities/ repeats (where relevant) may be made by telephone to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
28546	TREATMENT OF PATIENTS WITH CHRONIC MYELOID LEUKAEMIA - SECOND-LINE THERAPYThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for all phases of chronic myeloid leukaemia (CML) in the second-line treatment setting.Where the term TKI agent appears in the following notes and restrictions it refers to dasatinib or nilotinib.Patients are eligible for PBS-subsidised second-line treatment of CML if they have experienced treatment failure in the first-line treatment setting.Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib if they have not failed prior PBS-subsidised treatment with either dasatinib or nilotinib in the first-line treatment setting. Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between these agents if they have not failed prior PBS-subsidised treatment with that agent and may only occur for reasons of intolerance.Dasatinib is PBS-subsidised for all phases of CML (chronic, accelerated and blast phase) in the second-line treatment setting.Nilotinib is PBS-subsidised for chronic and accelerated phase CML in the second-line setting. Nilotinib is not approved for patients in blast crisis in any (first, second, third-line) treatment setting.Imatinib is not approved for second-line treatment of CML.1. Initial second-line treatmentA patient will be able to be prescribed either dasatinib or nilotinib within the initial 18 month treatment period as second-line therapy, as long as only one agent is approved at a time and providing the patient did not fail that drug as first-line therapy. During the initial 18 month treatment period, switching between approved second-line agents may only occur for reasons of intolerance, not failure of response.2. Continuing treatment for second-line treatmentFor continuing applications, patients must demonstrate response to PBS-subsidised treatment as follows:(i) within 18 months of the commencement of treatment, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108:28-37,2006) has been demonstrated may receive authorisation for a further 12 months of treatment; and(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained.All pathology reports must be documented in the patient's medical records.During second line continuing treatment beyond the initial 18 month treatment period, switching between approved second line TKI agents may only occur for reason of intolerance. Where there is failure of response, switching may only occur through application for prescription of a third line agent.3. Authority approval requirementsResponse criteria to initial treatment with dasatinib or nilotinib:For the purposes of assessing response to PBS-subsidised treatment with dasatinib or nilotinib, either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted and the results must be documented in the patient's medical records. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted and the results must be documented in the patient's medical records. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted and the results must be documented in the patient's medical records within 18 months of the commencement of treatment with dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent).4. Definitions of responseA major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells. A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response.5. Definitions of loss of responseLoss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.
28563	TREATMENT OF PATIENTS WITH CHRONIC MYELOID LEUKAEMIA - THIRD-LINE THERAPYThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of tyrosine kinase inhibitors (TKI) agents for all phases of chronic myeloid leukaemia (CML) in the third-line treatment setting.Where the term TKI agent appears in the following notes and restrictions it refers to dasatinib or nilotinib.Patients are eligible for PBS-subsidised third-line treatment of CML if they have experienced treatment failure in the second-line treatment setting.Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib if they have not failed prior PBS-subsidised treatment with either dasatinib or nilotinib in the first-line or second-line treatment setting. Patients are eligible for PBS-subsidised treatment with either dasatinib or nilotinib at any one time and must not be receiving concomitant interferon alfa therapy. Eligible patients may only swap between these agents if they have not failed prior PBS-subsidised treatment with that agent and may only occur for reasons of intolerance.Dasatinib is PBS-subsidised for all phases of CML (chronic, accelerated and blast phase) in the third-line treatment setting.Nilotinib is PBS-subsidised for chronic and accelerated phase CML in the third-line setting. Nilotinib is not approved for patients in blast crisis in any (first, second, third-line) treatment setting.Imatinib is not approved for third-line treatment of CML.1. Initial third-line treatmentThird-line treatment with a TKI can only be approved when imatinib has been used for first-line treatment. Patients will only be approved for PBS-subsidised treatment with one third-line agent.2. Continuing treatment for third-line treatmentFor continuing applications, patients must demonstrate response to PBS-subsidised treatment as follows:(i) within 18 months of the commencement of treatment, at which time patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) has been demonstrated may receive authorisation for a further 12 months of treatment; and(ii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been sustained.All pathology reports must be documented in the patient's medical records.3. Authority approval requirementsResponse criteria to initial treatment with dasatinib or nilotinib:For the purposes of assessing response to PBS-subsidised treatment with dasatinib or nilotinib, either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted and the result must be documented in the patient's medical records. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted and the results must be documented in the patient's medical records. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted and the results must be documented in the patient's medical records within 18 months of the commencement of treatment with dasatinib or nilotinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive continuing treatment with that agent).4. Definitions of responseA major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells. A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006) also indicates a response, at least the biological equivalent of a major cytogenetic response.5. Definitions of loss of responseLoss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) therapy. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.
28584	Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.auApplications for authority to prescribe should be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hposOr mailed to:Services AustraliaComplex DrugsReply Paid 9826HOBART TAS 7001
28585	1. Continuing treatment.For first continuing applications patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% has been demonstrated may receive authorisation for a further 12 months of treatment.2. Authority approval requirements.Response criteria to treatment with ponatinib:For the purposes of assessing response to PBS-subsidised treatment with ponatinib, either cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be conducted. For bone marrow analyses, where the standard karyotyping is not informative for technical reasons, a cytogenetic analysis performed on the bone marrow by the use of fluorescence in situ hybridisation (FISH) with BCR-ABL specific probe must be conducted. The cytogenetic or peripheral blood quantitative PCR analyses must be conducted within 18 months of the commencement of treatment with ponatinib (patients in whom a major cytogenetic response or peripheral blood BCR-ABL level of less than 1% is demonstrable by 18 months are eligible to receive first continuing treatment with this drug).Thereafter, at no greater than 12 month intervals a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% must be sustained to receive subsequent continuing treatments with this drug.3. Definitions of response.A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.A peripheral blood BCR-ABL level of less than 1% on the international scale (Blood 108: 28-37, 2006).4. Definitions of loss of response.Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor therapy.Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing tyrosine kinase inhibitor therapy.
28597	Pharmaceutical benefits that have the form etanercept injection 50 mg/mL, 4 x 1 mL syringes and pharmaceutical benefits that have the form etanercept injection 50 mg/mL, 4 x 1 mL pen devices and pharmaceutical benefits that have the form etanercept injection 50 mg/mL, 4 x 1 mL cartridges are equivalent for the purposes of substitution.
28601	WARNING: Ravulizumab increases the risk of meningococcal infections (septicaemia and/or meningitis).Please consult the approved PI for information about vaccination against meningococcal infection.
28663	It is recommended that patients have previously received 4 weeks of PBS-subsidised initial oral lead-in treatment with cabotegravir and rilpivirine.
28664	Applications for authorisation under this restriction may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone by contacting Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
28676	The international, evidence-based consensus iMCD diagnostic criteria developed by an international working group of clinical experts lists various findings under 'Major' and 'Minor' diagnostic criteria that constitute a diagnosis of iMCD. At the time of writing, under these consensus criteria, diagnostic findings that meet: (i) both Major criteria and (ii) at least 2 of 11 Minor criteria including at least 1 laboratory abnormality and (iii) exclude various differential diagnoses, form a diagnosis of iMCD.Details of these criteria are presented in Table 2 of the following literature article:Fajgenbaum DC, Uldrick TS, Bagg A, Frank D et. al. International, evidence-based consensus diagnostic criteria for HHV-8-negative/idiopathic multicentric Castleman disease. Blood 2017; 129(12): 1646-1657.Where updates to these diagnostic criteria have occurred since the publication, refer to the latest version.Do not contact the PBS-administrator to discuss whether an individual patient meets these consensus criteria.
28690	This pharmaceutical benefit is not for the treatment of chronic obstructive pulmonary disease (COPD).
28699	Pharmaceutical Benefits that have the brand Panzytrat 25 000 (Allergan) may be substituted for Pharmaceutical Benefits that have the brand Panzytrat 25 000 in the case of a shortage.
28735	Two completed authority prescriptions should be submitted with every initial application for this biological medicine.Prescribing the 40 mg presentation:For patients weighing at least 40 kg, one prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.Prescribing the 80 mg presentation:For patients weighing at least 40 kg, one prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.For patients weighing less than 40 kg, one prescription should be written for 1 dose of 80 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
28737	For the purposes of this restriction, PBS-subsidised 'CFTR modulator' means ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor and elexacaftor/ tezacaftor/ ivacaftor.
28738	For the purposes of this restriction, CFTR modulators, regardless if they are available as a single drug or in combination, are currently: elexacaftor, ivacaftor, lumacaftor, tezacaftor.
28755	Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.auApplications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hposOr mailed to:Services AustraliaComplex DrugsReply Paid 9826HOBART TAS 7001
28768	Where the term 'novel hormonal drug' appears in this restriction, it refers to: (i) abiraterone, (ii) apalutamide, (iii) darolutamide, (iv) enzalutamide.
28770	Two completed authority prescriptions should be submitted with every initial application for this biological medicine.Prescribing the 40 mg presentation:For patients weighing at least 40 kg, one prescription should be for the induction doses, containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats.For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.Prescribing the 80 mg presentation:For patients weighing at least 40 kg, one prescription should be for the 80 mg presentation with a quantity of 3 units and zero repeats. This will enable doses at week 0 and week 2 to be completed. The second prescription should be written for 2 doses of 40 mg and 2 repeats.For patients weighing less than 40 kg, one prescription should be written for 1 dose of 80 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.Requests for quantities/repeats insufficient to complete 16 weeks:If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be sought through the 'Balance of Supply' PBS restriction.
28785	Other disease modifying therapies for this condition are: (i) nusinersen, (ii) risdiplam.
28786	Recognised hospitals in the management of SMA are Queensland Children's Hospital (Brisbane), Royal Children's Hospital Melbourne, Monash Children's Hospital (Melbourne), John Hunter Hospital (Newcastle), Sydney Children's Hospital Randwick, Children's Hospital at Westmead, Adelaide Women and Children's Hospital and Perth Children's Hospital.
28787	Accredited treatment centres and suppliers are those organisations accredited by the Gene Technology Regulator under section 92 of the Gene Technology Act 2000.The following website provides a list of accredited organisations and may update without notice:https://www.ogtr.gov.au/what-weve-approved/accredited-organisations
28834	For the next authority application after this application, continue treatment through the 'Treatment phase: Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA listing' under the indication: 'Spinal muscular atrophy (SMA)'.
28835	For the next authority application after this application, continue treatment through the 'Treatment phase: Continuing treatment' under the indication: 'Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)'.
28846	Pharmaceutical benefits that have the forms darunavir tablet 600 mg, 2 x 30 and darunavir tablet 600 mg (as ethanolate), 60 are equivalent for the purposes of substitution.
28896	Pharmaceutical Benefits that have the brand APO-varenicline (Canada) may be substituted for Pharmaceutical Benefits that have the brand Champix in the case of a shortage.
28912	Pharmaceutical benefits that have the form etanercept injection 50 mg/mL, 4 x 1 mL syringes and pharmaceutical benefits that have the form etanercept injection 50 mg/mL, 4 x 1 mL pen devices are equivalent for the purposes of substitution.
28927	Use with caution if arterial disease present and avoid if severe arterial disease.
28962	This authority approval must be sought by the specified specialist prescriber.
28979	Pharmaceutical benefits that have the form rituximab 100 mg/10 mL injection, 2 x 10 mL vials and pharmaceutical benefits that have the form rituximab 100 mg/10 mL injection, 10 mL vial are equivalent for the purposes of substitution.
28980	Patients receiving clozapine under the PBS listing must be registered in the clozapine patient monitoring program relevant for the brand of clozapine being prescribed and dispensed: Novartis Clozaril Patient Monitoring System (eCPMS), Pfizer ClopineCentral or Juno Connected Clozitor.
29000	For a patient who has received non-PBS-subsidised supply of this drug, apply under an 'Initial treatment' phase listing provided that they meet all stated PBS eligibility criteria.
29040	The stated maximum amount in this listing is based on this drug's approved Product Information recommended dosing in specific cancer types - the drug may be prescribed in a quantity up to this amount, but need not be this amount for every cancer type. Refer to this drug's approved Product Information (Dose and Method of Administration or Clinical Trials sections) for the recommended dosing in the specific cancer type.
29061	Where there is already an approved authority prescription for the IV formulation, an authority application for this subcutaneously administered form can be made under one of:(1) The Balance of Supply listing - apply under this listing if the treatment phase (Initial treatment, First Continuing treatment, Subsequent Continuing treatment) is yet to be completed; the following authority application is to be under a Continuing treatment listing.(2) A Continuing treatment listing - apply under one of these types of listings where a treatment phase is concluding/has concluded; this typically occurs for the dose due at treatment week 16, 40, 64, 88 etc.
29079	Pharmaceutical benefits that have the form levothyroxine sodium 50 microgram tablet, 200 (Eutroxsig and Oroxine brands) and pharmaceutical benefits that have the form levothyroxine sodium 50 microgram tablet, 2 x 100 (Levoxine brand) are equivalent for the purposes of substitution.
29080	Pharmaceutical benefits that have the form levothyroxine sodium 75 microgram tablet, 200 (Eutroxsig and Oroxine brands) and pharmaceutical benefits that have the form levothyroxine sodium 75 microgram tablet, 2 x 100 (Levoxine brand) are equivalent for the purposes of substitution.
29081	Pharmaceutical benefits that have the form levothyroxine sodium 100 microgram tablet, 200 (Eutroxsig and Oroxine brands) and pharmaceutical benefits that have the form levothyroxine sodium 100 microgram tablet, 2 x 100 (Levoxine brand) are equivalent for the purposes of substitution.
29082	Pharmaceutical benefits that have the form levothyroxine sodium 200 microgram tablet, 200 (Eutroxsig and Oroxine brands) and pharmaceutical benefits that have the form levothyroxine sodium 200 microgram tablet, 2 x 100 (Levoxine brand) are equivalent for the purposes of substitution.
29086	This grandfather restriction will cease to operate from 14 months after the date specified in the clinical criteria.
29087	TREATMENT OF ADULT PATIENTS WITH SEVERE CHRONIC PLAQUE PSORIASISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological medicines adalimumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab and ustekinumab for adult patients with severe chronic plaque psoriasis. Therefore, where the term 'biological medicines' appears in notes and restrictions, it refers to adalimumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.A patient who received PBS-subsidised adalimumab, etanercept, guselkumab, infliximab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab treatment prior to 1 February 2019 is considered to start their first cycle as of 1 February 2019.A patient receiving PBS-subsidised treatment for chronic plaque psoriasis is able to commence a 'treatment cycle', where they may trial biological medicines without having to experience a disease flare, when swapping to an alternate biological medicine. Under these arrangements, within a single cycle, a patient may receive long-term treatment with a biological medicine as long as they sustain a response to therapy.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once. Therefore, once a patient fails to meet the response criteria for a PBS-subsidised biological medicine, they must change to an alternate biological medicine if they wish to continue PBS-subsidised biological treatment.Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Steven's Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered as a treatment failure.A patient must be assessed for response to each course of treatment according to the criteria included in the relevant continuing treatment restriction.Once a patient has either failed or ceased to sustain a response to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle.The duration of the break in therapy will be measured from the date the last prescription for PBS-subsidised treatment was approved in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle under Initial 3 treatment restriction.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle under Initial 2 treatment restriction.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.How to prescribe PBS-subsidised biological medicine treatment for severe chronic plaque psoriasis.There are separate restrictions for both the initial and continuing treatment for psoriasis affecting the whole body, versus psoriasis affecting the face, hands and feet.(1) Initial treatment.An application for initial treatment should be made where:(i) a patient has not received prior PBS-subsidised biological medicine treatment for this condition and wishes to commence such therapy (Initial 1 - New patient); or(ii) a patient who has received prior PBS-subsidised biological medicine therapy for this condition (initial or continuing) and wishes to trial an alternate biological medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years) [further details are under (4) 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same medicine (Initial 2 - Change or Recommencement of treatment after a break in biological medicine of less than 5 years).(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years).An application for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, etanercept, ixekizumab, and secukinumab, 20 weeks of therapy for guselkumab, 22 weeks of therapy for infliximab and 28 weeks of therapy for risankizumab, tildrakizumab and ustekinumab.It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of their course of initial treatment to ensure uninterrupted biological medicine supply.Grandfather patients (risankizumab only).A patient who commenced treatment with risankizumab for chronic plaque psoriasis prior to 1 August 2022 and who continues to receive treatment at the time of application, may qualify for treatment under the Initial treatment Grandfather treatment restriction.(2) Assessment of response to initial treatment.When prescribing initial treatment with a biological medicine, it is recommended that a PASI assessment is conducted after at least 12 weeks of treatment and no later than 4 weeks from the completion of this initial treatment course.The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.(3) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to Services Australia where applicable. Where a response assessment is not submitted where applicable, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Infliximab, adalimumab and etanercept only:For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy under the Initial 1 or Initial 2 treatment restrictions.For second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(4) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine without having to requalify with respect to the indices of disease severity (i.e. a PASI score of greater than 15), or the prior non-biological therapy requirements, except if the patient has had a break in therapy of more than 5 years who would need to requalify with respect to the indices of disease severity.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that particular biological medicine within the same cycle or have experienced treatment failure with that particular biological medicine that required permanent treatment withdrawal.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.(5) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline PASI assessment submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline PASI assessments any time that an initial or change or recommencement treatment application is submitted within a treatment cycle and this revised baseline PASI score will be used to assess the patient's response to the PBS-subsidised treatment.To ensure consistency in determining response, the same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of all continuing treatments.(6) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent treatment cycle following a break in PBS-subsidised biological therapy of at least 5 years, must qualify under Initial 3 treatment according to the criteria of the relevant restriction and index of disease severity. A PASI assessment must be conducted prior to application and patient must have a PASI score of greater than 15 for whole body. For the face, hand, foot at least 2 of the 3 PASI symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or the skin area affected is 30% or more of the face, palm of a hand or sole of a foot. The PASI assessment must be no older than 4 weeks at the time of application.
29102	Non-steroidal aromatase inhibitors for the purposes of this restriction are anastrozole and letrozole.
29190	Authority applications for increased quantities/repeats (where relevant) may be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/HPOS) or by telephone to Services Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. Monday to Friday).
29271	This drug belongs to the poly (ADP-ribose) polymerase (PARP) inhibitor drug class. The restriction refers to the following PARP inhibitors: olaparib, niraparib
29272	From 1 September 2022, the brand K.Quik has replaced the brand Betaquik.
29324	Prescribing/pharmacy claiming: prescribe/claim this benefit through the Section 100 Highly Specialised Drugs Program PBS item code(s) when administered for non-oncology indications. Prescribe/claim this benefit through the Efficient Funding of Chemotherapy PBS item code(s) when administered for oncology indications.
29326	PBS AUTHORITY APPLICATIONS FOR SEVERE ACTIVE RHEUMATOID ARTHRITISThe following information applies to Pharmaceutical Benefits Scheme (PBS) subsidy of the biological medicines for adults with severe active rheumatoid arthritis. Where the term biological medicine appears in the following notes and restrictions it refers to all PBS benefits with the specific PBS indication of: 'severe active rheumatoid arthritis'.Only one biological medicine is to be PBS-subsidised at any one time for rheumatoid arthritis.Upon 5 inadequate responses to biological medicines with the specific PBS indication of 'severe active rheumatoid arthritis', further subsidy is to cease. Where a particular biological medicine has provided an inadequate response, it must not be subsidised again.A serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment, including serious infusion or injection related reactions, Stevens Johnson Syndrome, development of a demyelinating lesion, progressive multifocal leukoencephalopathy and malignancy related to treatment with the biological medicine, is not considered a treatment failure.(1) Selecting the correct 'Treatment phase' listing to apply underInitiating subsidy:(i) Apply through 'Initial 1 treatment' where a patient has received no prior PBS-subsidised biological medicine treatment; or(ii) Apply through 'Initial 2 treatment' where one of the following occurs: (a) PBS-subsidised treatment has at least been initiated through any Initial 1 listing, but the prescribed biological medicine is changing, (b) there has been a break in biological medicine of less than 24 months, but resumption of treatment is with the same biological medicine last prescribed, (c) there has been a break in biological medicine of less than 24 months and resumption of treatment is with a different biological medicine to that last prescribed, (d) treatment with rituximab has occurred and is the most recent therapy prescribed leading up to this authority application, irrespective of the length in time elapsed between the 2 non-rituximab bDMARDs administered before and after rituximab.Initial 2 does not require markers of inflammation/joint count to be re-established - those recorded in the first Initial 1 application can remain as baseline measures. Prerequisite DMARD treatments need not be re-proven to be inadequate.The prescribed biological medicine may be changed at any time, regardless of whether the current prescribed biological medicine has been obtained through Initial treatment or Continuing treatment. However, the change in biological medicine cannot be back to the same biological medicine where that medicine has provided an inadequate response.(iii) Apply through 'Initial 3 treatment' where treatment is recommencing following a break in PBS-subsidised therapy of at least 24 months. Initial 3 requires current markers of inflammation/joint count to be re-established. Prerequisite DMARD treatments need not be re-proven to be inadequate. PBS-subsidised therapy in this instance can include rituximab where prescribed as the most recent treatment - the 24 month break in therapy is from the second dose of the prior rituximab course.Response assessment to any course of PBS-subsidised biological therapy must follow a minimum of 12 weeks of therapy. Applications made on the same day for Initial treatment and Continuing treatment clearly do reflect this requirement.Where a response assessment is not provided with a 'Continuing treatment' application, the biological medicine will be assumed to have failed, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Indicate where this has occurred in the authority application.Continuing subsidy:Apply under a 'Continuing treatment' phase listing only where treatment has initiated through an 'Initial treatment' listing and measures of disease control (i.e. ESR/CRP/joint count) demonstrate response following at least 12 weeks of treatment. Continuing treatment should never precede Initial treatment where the same biological medicine is being prescribed.The description of 'Continuing treatment' means 'Continuing treatment of severe rheumatoid arthritis with the same biological medicine'. Where treatment of severe rheumatoid arthritis is continuing with a different biological medicine, 'Continuing treatment' is not to be interpreted as meaning 'Continuing treatment of severe rheumatoid arthritis with a different biological medicine' - see 'Initial 2 treatment' where continuing treatment is with a different biological medicine.'Continuing treatment' is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment.Where continuing treatment is divided into 'First continuing' and 'Subsequent continuing', the next authority application following immediately after any 'Initial treatment' authority application is to be through 'First continuing'. Following this, the next authority application is to occur under the 'Subsequent continuing' treatment phase. Assuming the drug continues to provide an adequate response, 'Subsequent continuing' is to be accessed repeatedly until the prescribed biological medicine is either changed, stops providing an adequate response, or the patient takes a break in treatment.Balance of Supply listings:Maximum quantities and the number of repeats stated in a PBS-listing are values that prescribers may seek up to, but are not obligated to prescribe. From time to time, there may be particular reasons why a prescriber may elect not to request the full maximum quantity listed, or, the full number of repeat prescriptions. Where this occurs, the intent of Balance of Supply treatment phase listings is to circumvent the need for another written-only authority application to be completed, as a written-only authority application may not be practical in terms of providing timely access to continued treatment.Apply under a 'Balance of Supply' treatment phase (where available) when either the full maximum quantity or repeat prescriptions available under a particular treatment phase, was not requested and where the biological medicine has had insufficient time to demonstrate an adequate response. Where the preceding supply has been adequate to provide at least 12 weeks of treatment and has resulted in an adequate response, it may be more practical to access further treatment under 'Continuing treatment'.(2) Baseline measurements to determine response.Determination of response to treatment must be based on baseline measurements of the joint count, ESR and/or CRP submitted with the first authority application for a biological medicine. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications. Therefore, where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be used to determine response. Similarly, where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints.Applications under the Initial 1 treatment restriction for a new patient must include a joint count and ESR and/or CRP measured at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. The results must be no more than 4 weeks old at the time of application.Applications under the Initial 3 treatment restriction for recommencement of treatment after a break in biological medicine of more than 24 months must include a joint count and ESR and/or CRP measurement that is no more than 4 weeks old at the time of application.
29335	The Modified Monash Model categorises an area according to geographical remoteness and town size. Details can be found at: https://www.health.gov.au/health-topics/rural-health-workforce/classifications/mmm
29338	Pharmaceutical benefits that have the form glatiramer acetate 40 mg/mL syringes and pharmaceutical benefits that have the form glatiramer acetate 40 mg/mL pen devices are equivalent for the purposes of substitution.
29378	For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil; a prostanoid is one of: (f) epoprostenol, (g) iloprostAuthority applications for each agent in combination therapy should be made at the same time to reduce administrative handling. However, dosing of each agent need not occur simultaneously to be considered as 'combination therapy'.
29387	If this authority application is to continue combination therapy, but with a change in at least one agent, the 'Initial 3 - change' treatment phase restriction of the new drug(s) outlines the continuing eligibility of that new drug.
29390	The Centers for Disease Control and Prevention (U.S. Department of Health & Human Services) publishes Clinical Growth Charts which this restriction refers to. Both the 'length-for-age' (birth to 36 months) and 'stature-for-age' (children 2 years to 20 years) growth charts can be viewed, printed and reproduced via the following website link:https://www.cdc.gov/growthcharts/clinical_charts.htm
29414	Laron syndrome growth charts are those appearing in the following publication:Laron Z, Lilos P, Klinger B. Growth Curves for Laron syndrome. Arch Dis Child. 1993;68(6):768-770.This literature article can be accessed through the following website link:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1029371
29447	Any queries concerning the arrangements to prescribe may be directed to Services Australia on 1800 888 333.Prescribing information (including Authority Application forms and other relevant documentation as applicable) is available on the Services Australia website at www.servicesaustralia.gov.auApplications for authorisation under this restriction should be made in real time using the Online PBS Authorities system (see www.servicesaustralia.gov.au/hpos)Alternatively, applications for authority to prescribe can be submitted online using the form upload facility in Health Professional Online Services (HPOS) at www.servicesaustralia.gov.au/hposOr mailed to:Services AustraliaPBS AuthoritiesGPO Box 9826[Your capital city]
29448	An appropriate amount of drug (maximum quantity in units) may require prescribing both strengths. Note that the 60 mg pen is limited to dose increments of 0.5 mg and a maximum delivered dose of 30 mg, while the 24 mg pen is limited to 0.2 mg increments and a maximum delivered dose of 12 mg. Rounding (up or down) the weekly dose in mg is permitted to the nearest multiple of 0.5 or 0.2. Note that once opened, a pen is to be discarded after 28 days. Give consideration to strengths and combinations that minimise drug wastage.
29458	Prescribe an appropriate amount of drug (maximum quantity in units) that facilitates approximately 16 weeks of treatment per dispensing based on the Product Information recommended dosing of 0.66 mg/kg/week. Request up to 1 repeat prescription. With 1 repeat prescription, this treatment phase listing intends to provide approximately 32 weeks of treatment.See the table located on the following webpage which lists a range of patient weights (kg) and the corresponding number of units and combination of strengths to be sought in an authority application:https://www.pbs.gov.au/browse/section100-gh
29469	Prescribe an appropriate amount of drug (maximum quantity in units) that facilitates approximately 13 weeks of treatment per dispensing based on the Product Information recommended dosing of 0.66 mg/kg/week. Request up to 1 repeat prescription. With 1 repeat prescription, this treatment phase listing intends to provide approximately 26 weeks of treatment.See the table located on the following webpage which lists a range of patient weights (kg) and the corresponding number of units and combination of strengths to be sought in an authority application:https://www.pbs.gov.au/browse/section100-gh
29486	Pharmaceutical benefits that have the form oxybutynin chloride 5 mg tablet can be substituted for the form oxybutynin hydrochloride 5 mg tablet in the case of a shortage.
29528	Literature references for various instruments measuring motor function and quality of life in the context of spinal muscular atrophy are:Revised Upper Limb ModuleMazzone et al. 2017. Revised upper limb module for spinal muscular atrophy: Development of a new module. Muscle & Nerve 55(6):869-874Hammersmith Functional Motor Scale - ExpandedRamsey et al. 2017. Revised Hammersmith Scale for spinal muscular atrophy: A SMA specific clinical outcome assessment tool. PLoS ONE 12(2): e0172346. doi:10.1371/journal.pone.0172346.6-Minute Walk Test (6MWT)American Thoracic Society. 2002. ATS statement: Guidelines for the six-minute walk test. American Journal of Respiratory and Critical Care Medicine 166(1), pp 111-117The National Hearth Foundation of Australia has 6MWT test standardised instructions and recording forms located at: https://www.heartonline.org.au/resources/documents-and-links#exerciseSMA Health IndexZizzi et al. 2021. The Spinal Muscular Atrophy Health Index (SMA-HI): A Novel Outcome for Measuring How a Patient Feels and Functions. Muscle & Nerve 63(10), pp 837-844SMA Functional Rating ScaleElsheikh et al. 2018. Reliability of Spinal Muscular Atrophy Functional Rating Scale (SMAFRS) in Ambulatory Adults with Spinal Muscular Atrophy. Neurology April (15 Supplement) P4.452
29560	Pharmaceutical benefits that have the form fremanezumab 225 mg/1.5 mL syringes and pharmaceutical benefits that have the form fremanezumab 225 mg/1.5 mL pen devices are equivalent for the purposes of substitution.
29569	TREATMENT OF ADULT PATIENTS WITH ANKYLOSING SPONDYLITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, ixekizumab, secukinumab and upadacitinib for adult patients with ankylosing spondylitis.Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, ixekizumab, secukinumab and upadacitinib only.A patient is eligible for PBS-subsidised treatment with only 1 of the 8 biological medicines at any 1 time.Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a biological medicine while they continue to show a response to therapy.A patient who has been receiving PBS-subsidised adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, ixekizumab and secukinumab treatment prior to 1 October 2021 is considered to start their first cycle as of 1 October 2021.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once.Once a patient has either failed or ceased to respond to treatment 3 times, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 5-year break in PBS-subsidised biological medicine therapy before they are eligible to commence the next cycle. The 5-year break is measured from the date of the last prescription for PBS-subsidised biological medicine treatment in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new treatment cycle.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of less than 5 years may commence a further course of treatment within the same treatment cycle.A patient who has failed fewer than 3 biological medicines in a treatment cycle and who has a break in therapy of more than 5 years may commence a new treatment cycle.There is no limit to the number of treatment cycles a patient may undertake in their lifetime.(1) How to prescribe PBS-subsidised biological medicine treatment with adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, ixekizumab, secukinumab and upadacitinib.(a) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised biological medicine treatment in this treatment cycle and wishes to commence such therapy (Initial 1 - New patient)(ii) a patient has received prior PBS-subsidised (initial or continuing) biological medicine therapy and wishes to trial an alternate agent (Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to recommence treatment with a specific biological medicine following a break in PBS-subsidised therapy of less than 5 years with the same agent (Initial 2 - Change or Recommencement of treatment after a break in therapy of less than 5 years); or(iv) a patient wishes to recommence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 3 - Recommencement of treatment after a break in biological medicine of more than 5 years).A patient must be assessed for response to a course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy.(b) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine, a patient may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing biological medicine treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.Assessment of the patient's response to treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the cessation of the most recent course of biological medicine therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with that biological medicine, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.Infliximab, adalimumab and etanercept only:For the first continuing treatment course of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed for response following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment under the Initial 1, Initial 2 or Initial 3 treatment restrictions.For the second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised biological medicine is approved, a patient may swap to an alternate biological medicine within the same treatment cycle without having to requalify with respect to the indices of disease severity (i.e. the erythrocyte sedimentation rate (ESR), the C-reactive protein (CRP) levels and the BASDAI), or the prior NSAID therapy and exercise program requirements.A patient may trial an alternate biological medicine at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological medicine at the time of the application. However, they cannot swap to a particular biological medicine if they have failed to respond to prior treatment with that drug within the same treatment cycle.To ensure a patient receives the maximum treatment opportunities allowed under these arrangements, it is important that they are assessed for response to every course of treatment.A patient who is not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that biological medicine unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.(3) Baseline measurements to determine response.A response to treatment is to be determined by comparison of current disease activity measurements relative to the baseline measurements of the BASDAI, ESR and/or CRP submitted with the first authority application for a biological medicine.For a new patient, the BASDAI used to determine the baseline must be measured while the patient is receiving NSAID therapy and completing their exercise program.To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be used for all subsequent continuing treatment applications. Therefore, where only an ESR or CRP level is provided at baseline, an ESR or CRP level respectively must be used to determine response.Prescribers may provide new baseline measurements any time an 'Initial treatment' authority application is submitted within a treatment cycle and the eligibility for continuing treatment must be assessed according to these revised baseline measurements.(4) Recommencement of treatment after a 5-year break in PBS-subsidised therapy.A patient who wishes to trial a second or subsequent course of treatment following a break in PBS-subsidised biological medicine therapy of at least 5 years, must qualify under the Initial 3 treatment restriction. The same clinical criteria and indices of disease severity (i.e. the erythrocyte sedimentation rate (ESR), the C-reactive protein (CRP) levels and the BASDAI) as for the Initial 1 (New patient) restriction will need to be met, but a re-trial of NSAID therapy and exercise therapy is not required.
29611	Pharmaceutical benefits that have the brand Metalyse 50 mg injection [1 vial] (&) inert substance diluent [10 mL syringe], 1 pack and pharmaceutical benefits that have the brand TNKase 50 mg injection [1 vial] (&) inert substance diluent [10 mL syringe], 1 pack are equivalent for the purposes of substitution in the case of a shortage.
29612	Pharmaceutical benefits that have the form ethosuximide 250 mg capsule, 200, pharmaceutical benefits that have the form ethosuximide 250 mg capsule, 100, and pharmaceutical benefits that have the form ethosuximide 250 mg capsule, 56 are equivalent for the purposes of substitution.
29680	The PBS authority application administrator will approve a maximum quantity of vials in line with the following formula (based on the upper dose range of 0.12 mg/kg dosed twice daily, one vial containing 40 mg of drug and target supply duration of 30 days per dispensing):Number of vials equals 7.2 multiplied by weight (kg) divided by 40. For ease of reference, this equates to:Below 16 kg: up to 3 vials16 to 22 kg: up to 4 vials22 to 27 kg: up to 5 vials27 to 33 kg: up to 6 vials33 to 38 kg: up to 7 vials38 to 44 kg: up to 8 vialsBeyond 44 kg: refer to above formula
29759	Pharmaceutical benefits that have the form pyridostigmine bromide 180 mg modified release tablet in a pack size of 50 can be substituted for a pack size of 30 in the case of a shortage.
29786	Where both eyes are affected by the condition, a quantity of 2 units can be requested through the same authority application.
29790	Biosimilar prescribing policy Prescribing of the biosimilar brand Brenzys is encouraged for treatment naive patients.
29791	Encouraging biosimilar prescribing for treatment naive patients is Government policy. A viable biosimilar market is expected to result in reduced costs for biological medicines, allowing the Government to reinvest in new treatments. Further information can be found on the Medicines webpage (www.health.gov.au/health-topics/medicines).
29792	Biosimilar prescribing policyPrescribing of the biosimilar brand Pelgraz or Ziextenzo is encouraged for treatment naive patients.
29793	Biosimilar prescribing policyPrescribing of a biosimilar brand, Bemfola or Ovaleap, is encouraged for treatment naive patients.
29794	Biosimilar prescribing policyPrescribing of the biosimilar brand Amgevita, Hadlima, Hyrimoz or Idacio is encouraged for treatment naive patients.
29839	Prescribe an appropriate amount of drug (maximum quantity in units) that facilitates approximately 13 weeks of treatment per dispensing. Request up to 1 repeat prescription. With 1 repeat prescription, this treatment phase listing intends to provide approximately 26 weeks of treatment.An online calculator has been developed to assist in the determination of the quantity of drug to be sought. It is located in the following location:https://www.pbs.gov.au/browse/section100-gh
29864	Pharmaceutical benefits that have the form cefazolin 2 g injection, 5 vials, and pharmaceutical benefits that have the form cefazolin 2 g injection, 10 vials are equivalent for the purposes of substitution.
29914	The date of the decompensation event and date of initiation of treatment with this drug must be documented in the patient's medical records when PBS-subsidised treatment is initiated.
29916	Where a patient has had at least one PAH agent PBS-subsidised and the other(s) non-PBS-subsidised, apply under this 'Initial 2' treatment phase for the non-PBS-subsidised agent(s). Transitioning of the non-PBS to PBS-subsidised supply will be subject to restrictions in Initial 2. For the existing PBS-subsidised agent(s), the authority application(s) are to be through the Continuing treatment phase of that agent(s).
29920	Pharmaceutical benefits that have the form amoxicillin 250 mg/5 mL powder for oral liquid, 100 mL are equivalent for the purposes of substitution in the case of a shortage.
29921	Pharmaceutical benefits that have the form amoxicillin 875 mg + clavulanic acid 125 mg tablet in a pack size of 10 can be substituted for a pack size of 20 in the case of a shortage.
29960	Complement 5 (C5) inhibitors are defined as eculizumab or ravulizumab
30002	If patients have received non-PBS-subsidised treatment with pegcetacoplan for less than 4 weeks during initiation of therapy, the prescriber must contact the sponsor to receive the reminder of the non-PBS subsidised initial 4 weeks of therapy.
30047	Prior to prescribing this drug, the prescriber must contact the pharmaceutical company to confirm that the patient has received all relevant vaccinations. The prescriber will then be provided with a Controlled Distribution Reference Number (CDRN) and information about the pumps and consumables for use.
