6134	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of oxazepam below.
6135	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of nitrazepam below.
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.
6161	No applications for increased maximum quantities and/or repeats will be authorised.
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
6683	Any queries concerning the arrangements to prescribe adalimumab may be directed to Medicare 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) is available on the Medicare Australia website at www.medicareaustralia.gov.au. Written applications for authority to prescribe adalimumab should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
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.
6853	For item codes 5886T and 1904F, pharmaceutical benefits that have the form injection equivalent to 100 mg folinic acid in 10 mL are equivalent for the purposes of substitution.
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.
7668	Patients who have initiated treatment with thalidomide within the last month do not have to experience failure after a trial of at least 4 weeks of thalidomide or to have failed to achieve at least a minimal response after at least 8 weeks of thalidomide treatment.
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.
7734	Details of accepted toxicities including severity can be found on the Department of Human Services website at www.humanservices.gov.au.
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 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 Reply Paid 9826 HOBART TAS 7001
7766	Authority applications for new loading doses 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).
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.
7812	Helicobacter pylori eradication therapy should be considered.
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. 
7887	The first authority application may be faxed to the Department of Human Services on 1300 093 177 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). The Department will then contact the prescriber by telephone.
7888	Authority approvals will be administered by the Complex Drugs Unit of the Department of Human Services.
7894	Authority applications for continuing treatment in the same eye may be made by telephone on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
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.
7936	Written applications for authority to prescribe should be forwarded to: Department of Human ServicesComplex Drugs Reply Paid 9826 HOBART TAS 7001
7958	Patients who fail to demonstrate at least a partial response after 8 cycles will not be eligible to receive further PBS-subsidised treatment with bortezomib.
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.
8084	Details of acceptable toxicities including severity, associated with phototherapy, methotrexate and acitretin, can be found on the Department of Human Services website at www.humanservices.gov.au
8087	TREATMENT OF PATIENTS UNDER 18 YEARS WITH SEVERE CHRONIC PLAQUE PSORIASIS The following information applies to the prescribing of etanercept under the Pharmaceutical Benefits Scheme (PBS) for patients under 18 years with severe chronic plaque psoriasis. Applications for treatment of this condition will be limited to provide patients with a maximum of 24 weeks of therapy per course of treatment. A maximum of 16 weeks treatment with etanercept will be authorised for the primary application. The balance, a further 8 weeks treatment, will be authorised if the submitted Psoriasis Area and Severity Index (PASI) assessment demonstrates an adequate response to treatment. Where fewer than 3 repeats are requested at the time of the authority application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment may be requested by telephone.Once a patient has failed to respond to treatment 2 times, they must have, at a minimum, a 12 month break. The length of a treatment break is measured from the date the most recent treatment was stopped to the date of the first application for initial treatment. There are separate restrictions for treatment for psoriasis affecting the whole body, versus psoriasis affecting the face, hands and feet. (1) Application for approval for initial treatment. Applications for a course of initial treatment should be made for patients who have received no prior PBS-subsidised biological treatment and wish to commence such therapy. (2) Applications for approval for re-treatment. Applications for re-treatment with etanercept should be made in the following situations: (i) a patient who has received prior PBS-subsidised etanercept and experiences a disease flare, and wishes to start a second or subsequent treatment course with etanercept following a break of less than 12 months in PBS-subsidised therapy; or (ii) a patient who has received and failed to respond to prior PBS-subsidised etanercept and wishes to start a second or subsequent treatment course following a break of less than 12 months in PBS-subsidised therapy. For psoriasis affecting the whole body:Patients are eligible for re-treatment due to disease flare if there is a 50% or greater change in the patients PASI score or the patient has a current PASI score of greater than 15, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept.For psoriasis affecting the face, hand or foot:Patients are eligible for re-treatment due to disease flare if:(i) all subscores are rated moderate to severe or 2 of the three subscores are rated severe to very severe; OR(ii) the skin area affected is a 50% or greater change or the area affected is 30% or more of the face, palm of a hand or sole of a foot, compared to the most recent response assessment following cessation of the most recent 24 weeks of PBS-subsidised etanercept.(3) Applications for approval for completion of a courseApplications for a further 8 weeks of treatment to allow for completion of 24 weeks of therapy should be submitted with a PASI assessment.The PASI assessment must be conducted after at least 12 weeks of treatment. This assessment must be submitted to Department of Human Services (the Department) within 1 month of the completion of 12 weeks of treatment. Where a response assessment is not undertaken and submitted to the Department within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological agent. In circumstances where it is not possible to submit a response assessment within these timeframes, please call the Department on 1800 700 270 to discuss. (4) Baseline measurements to determine response. The Department will determine whether a response to treatment has been demonstrated, based on the baseline PASI assessment submitted with the first authority application for etanercept. However, prescribers may provide new baseline measurements any time that an initial or re-treatment authority is submitted and subsequent response will be assessed according to this revised PASI score. 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 gaining approval for the remainder of 24 weeks treatment. (5) Re-commencement of treatment after a 12 month break in PBS-subsidised therapy. A patient who wishes to start a second or subsequent treatment course with etanercept following a break in PBS-subsidised etanercept therapy of at least 12 months , must requalify for treatment under the initial treatment restriction. The most recent PASI assessment must be no more than 1 month old at the time of application. 
8094	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). Written application for authority approval for sufficient therapy to complete a maximum of 16 weeks of treatment should be forwarded to: Department of Human ServicesComplex Drugs Reply Paid 9826 HOBART TAS 7001
8110	It is recommended that an application is posted to the Department of Human Services no later than 2 weeks prior to the patient completing their initial 16 week treatment course to ensure continuity of treatment for those patients who meet the eligibility criterion for a further 8 weeks of PBS-subsidised etanercept treatment. 
8111	In circumstances where it is not possible to submit a response assessment after 12 weeks of treatment, please call the Department of Human Services on 1800 700 270 to discuss.
8112	The Department of Human Services will determine whether a response to treatment has been demonstrated, based on the baseline PASI assessment submitted with the first authority application for etanercept.
8175	Not for prophylaxis of deep vein thrombosis or peripheral arterial disease.
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.
8231	Pharmaceutical benefits that have the form macrogol-3350 1 g/g oral liquid: powder for, 510 g and pharmaceutical benefits that have the form macrogol-3350 1 g/g oral liquid: powder for, 30 x 17 g sachets are equivalent for the purposes of substitution.
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.
8668	No applications for increased maximum quantities will be authorised for the 56 tablet packs of the 150 mg and 200 mg strengths.
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.
8782	Any queries concerning patients who are enrolled on the Imatinib Compassionate Program may be directed to the Department of Human Services on 1800 700 270.
8786	Authority approval for continuing 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). 
9077	Subsequent 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).
9085	Contact the Department of Human Services before commencing PBS-subsidised treatment in cerebral palsy patients who have been treated for moderate to severe spasticity of the upper limb with non-PBS-subsidised botulinum toxin prior to the age of 18.
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.
9217	Pharmaceutical benefits that have the form olanzapine tablet 2.5 mg and pharmaceutical benefits that have the form olanzapine tablet 2.5 mg (as benzoate) are equivalent for the purposes of substitution.
9218	Pharmaceutical benefits that have the form olanzapine tablet 5 mg and pharmaceutical benefits that have the form olanzapine tablet 5 mg (as benzoate) are equivalent for the purposes of substitution.
9219	Pharmaceutical benefits that have the form olanzapine tablet 7.5 mg and pharmaceutical benefits that have the form olanzapine tablet 7.5 mg (as benzoate) are equivalent for the purposes of substitution.
9220	Pharmaceutical benefits that have the form olanzapine tablet 10 mg and pharmaceutical benefits that have the form olanzapine tablet 10 mg (as benzoate) are equivalent for the purposes of substitution.
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. 
9479	No more than 1 application per patient will 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. 
9733	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 not responding to non-opioid analgesics where the total duration of opioid analgesic treatment is less than 12 months; or(iii) first application for treatment beyond 12 months of chronic severe disabling pain not responding to non-opioid analgesics where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner, and the clinical need for continuing opioid analgesic treatment has been confirmed. The date of the consultation must be no more than 3 months prior to the application for a PBS authority. The full name of the medical practitioner consulted and the date of consultation are to be provided at the time of application; or (iv) subsequent application for treatment of chronic severe disabling pain not responding to non-opioid analgesics where a PBS authority prescription for treatment beyond 12 months has previously been issued for this patient.
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.
9854	This drug is not PBS-subsidised for use as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), an insulin or an SGLT2 inhibitor.
9871	This fixed dose combination tablet is not PBS-subsidised for use in combination with a sulfonylurea (triple oral therapy), or in combination with a dipeptidyl peptidase 4 inhibitor (gliptin), a glucagon-like peptide-1, an insulin or an SGLT2 inhibitor. 
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 hydrochloride), doxycycline tablet 100 mg (as monohydrate) and doxycycline capsule: modified release 100 mg (as 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 hydrochloride), doxycycline tablet 50 mg (as monohydrate) and doxycycline capsule: modified release 50 mg (as hydrochloride) are equivalent for the purposes of substitution.
10148	If the same physician cannot assess the patient please call the Department of Human Services on 1800 700 270.
10166	Carbzero is not nutritionally complete and is not intended for use as a sole source of nutrition.
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. 
10423	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 bDMARD 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 bDMARDs at any one time.From 1 April 2014, a patient receiving PBS-subsidised bDMARD therapy is considered to be in a treatment cycle where they may swap to an alternate bDMARD 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 bDMARD while they continue to show a response to therapy; and (ii) fail to respond or to sustain a response to each PBS-subsidised bDMARD once only.Once a patient has either failed or ceased to respond to PBS-subsidised bDMARD 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 therapy before they are eligible to receive further PBS-subsidised bDMARD therapy. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised bDMARD treatment was stopped to the date of the first application for initial treatment with a bDMARD under the new treatment cycle. A patient who was receiving PBS-subsidised bDMARD 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 bDMARD 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. A patient who has failed fewer than 3 trials of a bDMARD 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. A patient who has failed fewer than 3 trials of a bDMARD in a treatment cycle and who has a break in therapy of more than 12 months must commence a new treatment cycle. There is no limit to the number of treatment cycles a patient may undertake.(1) How to prescribe PBS-subsidised bDMARD therapy after 1 April 2014.(a) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised bDMARD treatment in this treatment cycle and wishes to commence such therapy (Initial 1); or (ii) a patient wishes to re-commence treatment with a bDMARD following a break in PBS-subsidised therapy of more than 12 months (Initial 1); or (iii) a patient has received prior PBS-subsidised (initial or continuing) bDMARD therapy and wishes to trial an alternate agent (Initial 2) [further details are under 'Swapping therapy' below]; or (iv) a patient wishes to re-commence treatment with a specific bDMARD following a break of less than 12 months in PBS-subsidised therapy with that agent (Initial 2). 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 this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD. For second and subsequent courses of PBS-subsidised bDMARD, it is recommended that a patient is reviewed in the 4 weeks prior to completing their current course of treatment and that an application is posted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course. (b) Continuing treatment.Following the completion of an initial treatment course with a specific bDMARD, 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 bDMARD 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 month prior to completing their current course of treatment to ensure uninterrupted bDMARD supply. Assessments of response to a course of PBS-subsidised therapy must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD. (2) Swapping therapy.Once initial treatment with the first PBS-subsidised bDMARD is approved, a patient may swap to an alternate bDMARD without having to requalify with respect to the indices of disease severity (joint count) or the prior non-bDMARD therapy requirements, except if the patient has had a break in therapy of more than 12 months. A patient may trial an alternate bDMARD at any time, regardless of whether they are receiving therapy (initial or continuing) with a bDMARD at the time of the application. However, they cannot swap to a particular bDMARD if they have failed to respond to prior treatment with that drug within the current 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 bDMARD should be accompanied by the approved authority prescription or remaining repeats for the bDMARD the patient is ceasing.(3) 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 joint count submitted with the first authority application for a bDMARD. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is submitted within a treatment cycle and the Department of Human Services will assess response according to the revised baseline measurement. (4) Re-commencement 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 bDMARD therapy of at least 12 months, must requalify for treatment under the Initial 1 treatment restriction.(5) Withdrawal of treatment after sustained remission.Withdrawal of treatment with bDMARDs 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 the Department of Human Services at the time treatment is ceased.
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. 
10500	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 bDMARD 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 bDMARDs at any one time.From 1 April 2014, a patient receiving PBS-subsidised bDMARD therapy is considered to be in a treatment cycle where they may swap to an alternate bDMARD 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 bDMARD while they continue to show a response to therapy; and (ii) fail to respond or to sustain a response to each PBS-subsidised bDMARD once only.Once a patient has either failed or ceased to respond to PBS-subsidised bDMARD 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 bDMARD therapy before they are eligible to receive further PBS-subsidised bDMARD therapy. The length of a treatment break is measured from the date of the last approval for PBS-subsidised bDMARD therapy in the last treatment cycle to the date of the first application for initial treatment with a bDMARD under the new treatment cycle. A patient who was receiving PBS-subsidised bDMARD 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 bDMARD 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.A patient who has failed fewer than 3 trials of a bDMARD 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. A patient who has failed fewer than 3 trials of a bDMARD in a treatment cycle and who has a break in therapy of more than 24 months must commence a new treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with PBS-subsidised bDMARD treatment was stopped to the date of the first application for initial treatment with a bDMARD under the new treatment cycle. There is no limit to the number of treatment cycles a patient may undertake.(1) How to prescribe PBS-subsidised bDMARD therapy after 1 April 2014.(a) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised bDMARD treatment in this treatment cycle and wishes to commence such therapy (Initial 1); or (ii) a patient wishes to re-commence treatment with a bDMARD following a break in PBS-subsidised therapy of more than 24 months (Initial 1); or (iii) a patient has received prior PBS-subsidised (initial or continuing) bDMARD therapy and wishes to trial an alternate agent (Initial 2) [further details are under 'Swapping therapy' below]; or (iv) a patient wishes to re-commence treatment with a specific bDMARD following a break of less than 24 months in PBS-subsidised therapy with that agent (Initial 2). 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 this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD. For second and subsequent courses of PBS-subsidised bDMARD, it is recommended that a patient is reviewed in the 4 weeks prior to completing their current course of treatment and that an application is posted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course. (b) Continuing treatment.Following the completion of an initial treatment course with a specific bDMARD, 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. A patient remains eligible to receive continuing bDMARD 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 month prior to completing their current course of treatment to ensure uninterrupted bDMARD supply. Assessments of response to a course of PBS-subsidised therapy must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised bDMARD is approved, a patient may swap to an alternate bDMARD without having to requalify with respect to the indices of disease severity (joint count and ESR/CRP) or the prior non-bDMARD therapy requirements, except if the patient has had a break in therapy of more than 24 months. A patient may trial an alternate bDMARD at any time, regardless of whether they are receiving therapy (initial or continuing) with a bDMARD at the time of the application. However, they cannot swap to a particular bDMARD if they have failed to respond to prior treatment with that drug within the current 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 bDMARD should be accompanied by the approved authority prescription or remaining repeats for the bDMARD the patient is ceasing. (3) 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 joint count submitted with the first authority application for a bDMARD. However, prescribers may provide a new baseline measurement any time that an initial treatment authority application is submitted within a treatment cycle and the Department of Human Services will assess response according to the revised baseline measurement. (4) Re-commencement of treatment after a 24 month break in PBS-subsidised therapy.A patient who wishes to start a second or subsequent treatment cycle following a break in PBS-subsidised bDMARD therapy of at least 24 months, must requalify for treatment under the Initial 1 treatment restriction. 
10511	Authority approval for sufficient therapy to complete a maximum of 24 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).Written application for authority approval for sufficient therapy to complete a maximum of 24 weeks of treatment should be forwarded to: Department of Human ServicesComplex DrugsReply Paid 9826HOBART TAS 7001
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).
10626	Authority approval for sufficient therapy to complete a maximum of 24 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). Written application for authority approval for sufficient therapy to complete a maximum of 24 weeks of treatment should be forwarded to: Department of Human Services Prior Written Approval of Complex Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001 
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.
11010	Refer to the Department of Human Services website at www.humanservices.gov.au for a list of designated hospitals. 
11030	Applications for patients who wish to swap to an alternate PAH agent should be accompanied by the previously approved authority prescription, or remaining repeats, for the treatment the patient is ceasing.
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
11101	Where the 62.5 mg tablet strength is required for the second authority prescription, please contact the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) for further advice.The approved second authority prescription will be returned to the prescriber by the Department of Human Services two weeks after the date of the approval of the first authority prescription, to allow for the uninterrupted completion of the six months initial treatment course. The Department of Human Services will contact prescribers prior to dispatch of the second authority prescription to confirm the tablet strength required for the patient.
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
11205	Authority approval for sufficient therapy to complete a maximum of 18 to 20 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). Written application for authority approval for sufficient therapy to complete a maximum of 18 to 20 weeks of treatment should be forwarded to: Department of Human ServicesPrior Written Approval of Complex Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
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.
11698	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 Services Prior Written Approval of Complex DrugsReply Paid 9826HOBART TAS 7001
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.
11951	No increase in the maximum quantity or number of units may be authorised.No increase in the maximum number of repeats may be authorised.Special Pricing Arrangements apply.
11970	Authority approval for sufficient therapy to complete a maximum of 18-20 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).Written application for authority approval for sufficient therapy to complete a maximum of 18-20 weeks of treatment should be forwarded to: Department of Human ServicesPrior Written Approval of Complex DrugsReply Paid 9826HOBART TAS 7001
11971	Authority approval for sufficient therapy to complete a maximum of 24 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).Written application for authority approval for sufficient therapy to complete a maximum of 24 weeks of treatment should be forwarded to: Department of Human ServicesPrior Written Approval of Complex DrugsReply Paid 9826HOBART TAS 7001
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.
12367	For item codes 8740B and 1610R, pharmaceutical benefits that have the form injection equivalent to 50 mg folinic acid in 5 mL are equivalent for the purposes of substitution.
12368	For item codes 5890B and 1899Y, pharmaceutical benefits that have the form injection equivalent to 50 mg folinic acid in 5 mL are equivalent for the purposes of substitution.
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.
12449	An initial dose of 1300 mg of PBS-subsidised ofatumumab must be made up of 3 vials of 100 mg and 1 vial of 1000 mg.
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.
12871	Patients who fail to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this Treatment Cycle. Patients may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological agent was approved in this Cycle and the date of the first application under the new Cycle.
12912	This medicine is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.
12958	Risk of end-organ damage or mortality includes a minimum of one of the following:Glomerulonephritis with risk of progression Risk to sight including scleritis/episcleritis, sudden visual loss, uveitis, retinal changes (vasculitis/thrombosis/exudates/haemorrhage) Bronchial/subglottic obstruction Pulmonary haemorrhage Parenchymal lung disease Sensory neural hearing loss Recurrent sinonasal disease requiring recurrent surgical interventions Meningitis, organic confusion, seizures, stroke, cord lesion, cranial nerve palsy, sensory peripheral neuropathy, motor mononeuritis multiplex 
12959	At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug for four weeks of treatment.
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.
13077	The in-use shelf life of Optive is 6 months from the date of opening. 
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.
13122	For item codes 1257E and 1797N, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
13124	For item codes 5478H and 1799Q, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
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.
13531	Pharmaceutical benefits that have the forms clopidogrel tablet 75 mg, clopidogrel tablet 75 mg (as besilate) and clopidogrel tablet 75 mg (as hydrogen sulfate) are equivalent for the purposes of substitution.
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.
13610	For item codes 1784X and 1788D, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
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)
13847	Authorities for increased maximum quantities and/or repeats will be granted only for:(i) severe disabling pain associated with proven malignant neoplasia; or(ii) chronic severe disabling pain not responding to non-opioid analgesics where the total duration of opioid analgesic treatment is less than 12 months; or(iii) first application for treatment beyond 12 months of chronic severe disabling pain not responding to non-opioid analgesics where the patient's pain management has been reviewed through consultation by the patient with another medical practitioner, and the clinical need for continuing opioid analgesic treatment has been confirmed. The date of the consultation must be no more than 3 months prior to the application for a PBS authority. The full name of the medical practitioner consulted and the date of consultation are to be provided at the time of application; or (iv) subsequent application for treatment of chronic severe disabling pain not responding to non-opioid analgesics where a PBS authority prescription for treatment beyond 12 months has previously been issued for this patient.
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.
13946	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of codeine phosphate with paracetamol.
13947	Each authority approval will be limited to no more than 240 tablets per month for no more than 6 months.
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.
14042	Authorities for increased maximum quantities and/or repeats will be granted only for severe disabling pain not responding to non-opioid analgesics.
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 Department of Human Services website (www.humanservices.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.
14330	Sunitinib malate is not PBS-subsidised for the treatment of patients with resectable malignant gastrointestinal stromal tumours.
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.
14397	This drug is not PBS-subsidised for use in combination with an anti-EGFR antibody.
14399	Bevacizumab is not PBS-subsidised when chemotherapy partners are switched whilst maintaining a bevacizumab backbone in the face of progressive disease.
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.
14545	Treatment of this indication is limited to 6 months. See Australian Product Information
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.
14706	No more than 15 treatments (1 initial and 14 continuing) per eye will be authorised.
14707	The Department of Human Services should be notified if treatment is abandoned prior to completion of the laser activation step but after infusion of verteporfin. Telephone 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). The reason treatment is abandoned must be provided. Where such notification has been made, the treatment so affected will not count towards the maximum.
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). 
14736	A patient is eligible for a total of 15 subsidised treatments per eye. This maximum includes treatments administered under the MBS Visudyne Therapy Program and the PBS.
14763	Patients will be eligible for a maximum of one script as initial therapy to enable their response to treatment with sapropterin to be assessed.
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.
15090	For item codes 6208R and 1837Q, pharmaceutical benefits that have the form capsule 250 mg are equivalent for the purposes of substitution.
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.
15116	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).Written applications for authority approval for sufficient therapy to complete the balance of supply should be forwarded to:Department of Human ServicesComplex DrugsReply Paid 9826 HOBART TAS 7001
15124	The period between commencing a course of bupropion hydrochloride and varenicline tartrate must be at least 6 months. 
15212	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) or Hospira Clopineconnect.
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.
15682	Patients will be able to trial either eltrombopag or romiplostim within the initial 24 weeks treatment period. Patients who fail to demonstrate a response to treatment with eltrombopag and/or romiplostim under the initial restriction will not be eligible to receive further PBS-subsidised treatment with either of these drugs.
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.
16056	Obinutuzumab is not to be used as monotherapy or in combination with anti-cancer drugs other than chlorambucil.
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.
16646	Any queries concerning the arrangements to prescribe this drug 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.auWritten applications for authority to prescribe this drug should be forwarded to:Department of Human ServicesComplex DrugsReply Paid 9826 HOBART TAS 7001
16668	For item codes 2414C and 1810G, pharmaceutical benefits that have the form tablet 20 mg are equivalent for the purposes of substitution.
16669	For item codes 2642C and 1841X, pharmaceutical benefits that have the form tablet 600 mg (sustained release) 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.
16714	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, cyclosporin or acitretin can be found on the Department of Human Services website (www.humanservices.gov.au)
16725	For item codes 9501C and 1839T, pharmaceutical benefits that have the form capsule 250 mg are equivalent for the purposes of substitution
16727	For item codes 2600W and 1557Y, pharmaceutical benefits that have the form tablet 100 mg are equivalent for the purposes of substitution.
16728	The dose should be adjusted in accordance with renal function.
16731	Oestradiol 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.
16797	Assessment of a patient's response to an initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 4 weeks from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab.
16800	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 a 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 respond 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 receive further PBS-subsidised tocilizumab therapy. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised tocilizumab treatment was stopped to the date of the first application for initial treatment with tocilizumab under the new treatment cycle.A patient who was receiving PBS-subsidised tocilizumab treatment immediately prior to 1 May 2012 is considered to be in their first cycle as of 1 May 2012. A patient who has had a break in tocilizumab treatment of at least 12 months immediately prior to making a new application, on or after 1 May 2012, will commence a new treatment cycle. A patient who has failed their first course of tocilizumab in a treatment cycle and who has a break in therapy of less than 12 months may commence a second course of treatment within the same treatment cycle.A patient who has failed their first course of tocilizumab in a treatment cycle and who has a break in therapy of more than 12 months must commence a new treatment cycle. (1) How to prescribe PBS-subsidised tocilizumab therapy after 1 May 2012. (a) Initial treatment. Applications for initial treatment should be made where: (i) a patient has received no prior PBS-subsidised tocilizumab treatment in this treatment cycle and wishes to commence such therapy (Initial 1); or (ii) a patient wishes to recommence treatment with tocilizumab following a break in PBS-subsidised therapy of more than 12 months (Initial 1); or (iii) 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 a response and the treating physician wishes to trial a second course, provided any break in therapy is less than 12 months (Initial 2); or(iv) a patient wishes to recommence treatment with tocilizumab following a break in PBS-subsidised therapy of less than 12 months (Initial 2). 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 this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab for that course. For second and subsequent courses of PBS-subsidised tocilizumab, it is recommended that a patient is reviewed in the 4 weeks prior to completing their current course of treatment and that an application is posted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course. (b) 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 tocilizumab providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing tocilizumab treatment in courses of up to 24 weeks providing they continue to sustain the response. It is recommended that a patient be reviewed in the month 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 submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with tocilizumab. (2) 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) or the prior therapy requirements, 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. (3) Baseline measurements to determine response. The Department of Human Services will determine whether a response to treatment has been demonstrated based on the 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 a 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. The Department of Human Services will assess response according to these revised baseline measurements. 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 by the Department of Human Services to assess response to the second course. (4) 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 1 treatment restriction. (5) 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 the Department of Human Services at the time treatment is ceased.
16841	Written applications for authority to prescribe should be forwarded to: Department of Human ServicesPrior Written Approval of Complex Drugs Reply Paid 9826 HOBART TAS 7001
16851	For item codes 8812T and 1704Q, pharmaceutical benefits that have the form injection equivalent to 100 mg folinic acid in 10 mL are equivalent for the purposes of substitution.
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.
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.
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.
16875	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.
16876	Up to six months' treatment (i.e. one month's treatment with five repeats) may be requested.
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.
16972	For the following diseases, written authority is required at initiation and for continuation:Dermatofibrosarcoma protuberans;Hypereosinophilic syndrome;Chronic eosinophilic leukaemia;Myelodysplastic or myeloproliferative disorder;Aggressive systemic mastocytosis with eosinophilia.
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
17050	Authority approval for sufficient therapy to complete a maximum of 24 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).Written application for authority approval should be forwarded to: Department of Human ServicesComplex DrugsReply Paid 9826HOBART TAS 7001
17097	The patient must have signed a patient acknowledgement indicating they understand and acknowledge that the PBS-subsidised treatment will cease if they do not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
17123	Authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats 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).
17135	This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
17136	It is recommended that an application for 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 continuation criterion for PBS-subsidised treatment with this drug.
17183	Details of the accepted toxicities including severity can be found on the Department of Human Services website.
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
17369	A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.In circumstances where it is not possible to submit a response assessment within these timeframes, please call the Department of Human Services on 1800 700 270 to discuss.
17373	It is recommended that an application is posted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug.
17376	Patients who fail to demonstrate a response to treatment with 3 biological agents are deemed to have completed this Treatment Cycle and must cease PBS-subsidised therapy. These patients may recommence a new Biological Treatment Cycle after a minimum of 5 years has elapsed between the date the last prescription for a PBS-subsidised biological agent was approved in this Cycle and the date of the first application under the new Cycle.
17377	A PASI assessment of the patient's response to this initial course of treatment must be made after at least 12 weeks of treatment so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. In circumstances where it is not possible to submit a response assessment within these timeframes, please call the Department of Human Services on 1800 700 270 to discuss.
17382	A PASI assessment of the patient's response must be conducted within 4 weeks prior to completion of this course of treatment. This assessment, which will be used to determine eligibility for further continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug. In circumstances where it is not possible to submit a response assessment within these timeframes, please call the Department of Human Services on 1800 700 270 to discuss.
17581	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. 1. Continuing treatmentAll continuing applications are to be written and must include a pathology report demonstrating the patient has responded 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% 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. 2. Authority approval requirements.Response criteria to initial 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 submitted. 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 submitted. The cytogenetic or peripheral blood quantitative PCR analyses must be submitted within 18 months of the commencement of treatment with dasatinib, nilotinib or 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 continuing treatment with that agent). 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) also indicates a response, at least the biological equivalent of a major cytogenetic response. 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.
17698	It is recommended that an application is submitted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug.
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.
17796	Patients could be considered contraindicated, refractory, or unable to tolerate cyclophosphamide for one of the following reasons: Cyclophosphamide is contraindicated as per the TGA approved Product Information; Cyclophosphamide is not recommended due to the need to preserve gonad function; Patient experiences severe toxicity to cyclophosphamide that warrants cessation of treatment; Patient has life- or organ-threatening deterioration at any time during treatment with cyclophosphamide, where the deterioration is thought to be due to severe uncontrolled active vasculitis; Commencing a further treatment cycle with cyclophosphamide would exceed the maximum cumulative dose of cyclophosphamide of 25g; or Patient's condition with this indication is persistent despite at least 3 months therapy with cyclophosphamide. 
17861	To ensure consistency in determining response, the same indices of disease severity used to establish baseline must be provided for all subsequent continuing treatment applications. 
17883	An assessment of the patient's response to a continuing course of therapy should be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criteria. 
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. 
17937	The authority application must be made in writing and must include: (1) A completed authority prescription form; and(2) A completed Myelofibrosis Authority Application Supporting Information Form, which includes all of the following: (a) A copy of the bone marrow biopsy report confirming diagnosis of myelofibrosis; and(b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS. 
17938	Written applications for authority to prescribe should be forwarded to: Department of Human ServicesComplex Programs Reply Paid 9826 HOBART TAS 7001
17939	No increase in the maximum quantity may be authorised for the 15 mg and 20 mg dose strengths.
17940	The authority application must be made in writing and must include: (1) A completed authority prescription form; and(2) A completed Myelofibrosis Authority Application Supporting Information Form, which includes all of the following:a) A copy of the bone marrow biopsy report confirming diagnosis of myelofibrosis;b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS; and c) A confirmation that the patient's disease related symptoms are resistant, refractory or intolerant to available therapy. 
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
18152	No increase in the maximum quantity or number of units may be authorised with one exception: where a patient has a break in therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose up to a maximum of 1000 mg.
18195	Pharmaceutical benefits that have the form flucloxacillin 1 g injection in a pack size of 5 can be substituted for a pack size of 10 in the case of a shortage.
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 amoxycillin 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 amoxycillin 500 mg (as trihydrate) are equivalent for the purposes of substitution.
18707	Pharmaceutical benefits that have the form ranitidine tablet 150 mg (as hydrochloride) and pharmaceutical benefits that have the form ranitidine tablet, effervescent, 150 mg (as hydrochloride) 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 tablet: modified release, 96 and pharmaceutical benefits that have the form paracetamol 665 mg tablet: modified release, 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.
19030	The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
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.
19407	This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamphetamine sulphate or modafinil.
19408	This drug is not PBS-subsidised when used in combination with PBS-subsidised dexamphetamine sulphate or armodafinil.
19460	Patient must be registered in the i-access risk management program.
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.
19604	Authority approval for sufficient therapy to complete a maximum of 24 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).
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.
20025	The 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. 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 treatment From 1 April 2012, under the PBS, a 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 respond2. Continuing First-line treatmentPatients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% to receive continuing therapy.First continuing applications are to be written and must include a pathology report demonstrating the patient has responded to the initial course of treatment.Second and subsequent authority applications for continuing therapy may be made by telephoning the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).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 requirements.Response 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 submitted. 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 submitted. The cytogenetic or peripheral blood quantitative PCR analyses must be submitted within 18 months of the commencement of treatment with imatinib mesilate, 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.
20056	The 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. Where the term TKI agent appears in the following notes and restrictions it refers to dasatinib or nilotinib. Imatinib mesilate is not approved for use in second or third line treatment.Patients are eligible for PBS-subsidised treatment with only one of 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.Nilotinib is not approved for patients in blast crisis.1. Initial second line treatmentFrom 1 April 2012, under the PBS, a 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. Initial third line treatmentThird-line treatment with a TKI can only be approved when imatinib is used for first-line treatment. Patients will only be approved for PBS-subsidised treatment with one third-line agent.From 1 April 2012, under the PBS, a patient will be able to be prescribed either dasatinib or nilotinib providing the patient did not fail that drug as first or second line therapy and for nilotinib the patient is not in blast crisis.3. Continuing treatment for second and third line treatmentAll continuing applications are to be written and must include a pathology report demonstrating the patient has responded 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% 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.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.4. Authority approval requirements.Response 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 submitted. 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 submitted. The cytogenetic or peripheral blood quantitative PCR analyses must be submitted 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).5. 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) also indicates a response, at least the biological equivalent of a major cytogenetic response.6. 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 (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.
20096	Authority applications for second and subsequent continuing 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).
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).
20187	Authority approval for sufficient therapy to complete a maximum of 28 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).
20188	Authority approval for sufficient therapy to complete a maximum of 22 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).
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.
20373	TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE RHEUMATOID ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological disease modifying antirheumatic drugs (bDMARDs) for adults with severe active rheumatoid arthritis. Where the term bDMARD appears in the following notes and restrictions it 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).Patients are eligible for PBS-subsidised treatment with only 1 of the above biological disease modifying anti-rheumatic drugs at any 1 time.In order to be eligible to receive PBS-subsidised treatment with rituximab, a patient must have already failed to demonstrate a response to at least 1 course of treatment with a PBS-subsidised TNF-alfa antagonist.A patient receiving PBS-subsidised bDMARD therapy may swap to an alternate bDMARD without having to experience a disease flare. Under these interchangeability arrangements:- a patient may continue to receive long-term treatment with a PBS-subsidised bDMARD while they continue to show a response to therapy,- a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised bDMARD more than once, and- once a patient has either failed or ceased to respond to treatment 5 times, they will not be eligible to receive further PBS-subsidised bDMARDs for the treatment of rheumatoid arthritis.For patients who have failed PBS-subsidised treatment with 2 or 3 TNF-alfa antagonists prior to 1 August 2010 please contact the Department of Human Services on 1800 700 270. A patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, may apply for a further course of rituximab under the Continuing treatment restriction. A patient who has failed fewer than 5 bDMARDs and who has a break in therapy of less than 24 months may commence a further course of treatment with a bDMARD without having to requalify under the Initial 1 treatment restriction. A patient who has failed fewer than 5 bDMARDs and who has had a break in therapy of longer than 24 months must requalify for treatment under the Initial 1 treatment restriction. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised bDMARD treatment is stopped to the date of the new application for treatment with a bDMARD.(1) How to prescribe PBS-subsidised bDMARD therapy after 1 August 2010.(a) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised bDMARD treatment and wishes to commence such therapy, excluding rituximab (Initial 1); or(ii) a patient wishes to re-commence treatment with a bDMARD following a break in PBS-subsidised therapy of more than 24 months (Initial 1); or(iii) a patient has received prior PBS-subsidised (initial or continuing) bDMARD therapy and wishes to trial an alternate agent (Initial 2) [further details are under 'Swapping therapy' below]; or(iv) a patient wishes to re-commence treatment with a specific bDMARD following a break of less than 24 months in PBS-subsidised therapy with that agent (Initial 2).Initial applications for new or re-commencing patients (Initial 1) 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.Initial treatment authorisations will be limited to provide a maximum of 16 weeks of therapy for abatacept, adalimumab, baricitinib, etanercept, golimumab, tocilizumab and tofacitinib, 18 to 20 weeks of therapy with certolizumab pegol (depending upon the dosing regimen), 22 weeks of therapy for infliximab and 2 infusions of rituximab.A patient must be assessed for response to any course of initial PBS-subsidised treatment (excluding rituximab) following a minimum of 12 weeks of therapy and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Rituximab patients must be assessed following a minimum of 12 weeks after the first infusion, and this assessment must be submitted to the Department of Human Services within 4 weeks.Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD. For second and subsequent courses of PBS-subsidised bDMARD (excluding rituximab) treatment it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that where required an application is submitted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course.Abatacept patients:Patients are eligible to receive one I.V. loading dose when commencing treatment with the subcutaneous formulation. For these patients two prescriptions are required, the first prescription for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats, must be submitted with the initial application.Rituximab patients:A further application may be submitted to the Department of Human Services 24 weeks after the first infusion. New baselines may be submitted with this application if appropriate.(b) Continuing treatment.Following the completion of an initial treatment course with a specific bDMARD (excluding rituximab), 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 bDMARD 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 bDMARD supply.Rituximab patients:A patient may qualify to receive a further course of treatment (every 24 weeks) with this agent providing they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with rituximab. The patient remains eligible to receive a course of rituximab every 24 weeks providing they continue to demonstrate a response as specified in the restriction. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD.(2) Swapping therapyOnce initial treatment with the first PBS-subsidised bDMARD is approved, a patient may swap to an alternate bDMARD 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 joint count) or the prior non- bDMARD therapy requirements, except if the patient has had a break in therapy of more than 24 months. However the requirement for concomitant treatment with methotrexate, where it applies, must be met for each bDMARD trialled.Patients who are not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that agent.A patient may trial an alternate bDMARD at any time, regardless of whether they are receiving therapy (initial or continuing) with a bDMARD at the time of the application. However, they cannot swap to a particular bDMARD if they have failed to respond to prior treatment with that drug.Abatacept:Patients swapping from I.V. abatacept to subcutaneous abatacept will not be eligible for an I.V. loading dose when commencing treatment with the subcutaneous formulation.Rituximab:In order to trial rituximab, a patient must have trialled and failed to demonstrate a response to at least 1 PBS-subsidised TNF-alfa antagonist treatment.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, within the timeframes specified in the relevant restriction.PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised bDMARD during the required treatment-free period applying to patients who have demonstrated a response to their most recent course of rituximab. This means that patients who have demonstrated a response to a course of rituximab must have a PBS-subsidised bDMARD therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD. Patients who fail to respond to rituximab and who qualify and wish to trial a course of an alternate bDMARD may do so without having to have any treatment-free period.To avoid confusion, an application for a patient who wishes to swap to an alternate bDMARD should be accompanied by the prescription or remaining repeats for the bDMARD the patient is ceasing.(3) 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 joint count, ESR and/or CRP submitted with the first authority application for a bDMARD. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted and the Department of Human Services will assess response according to these revised baseline measurements.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 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 will 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 demonstrated on the total number of major joints.Except as specified under the Initial 1 treatment restriction, a baseline joint count and ESR and/or CRP should be performed whilst the patient is still on treatment or within 1 month of ceasing prior treatment. Applications under the Initial 1 treatment restriction for new or re-commencing patients 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.
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.
20554	An increase in maximum number of repeats of up to 2 will be allowed for completion of consolidation therapy.
20555	No increase in the maximum number of repeats will be authorised for completion of induction therapy.
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.
20639	Authority applications for continuing treatment may be made by telephone on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).
20652	Applications for treatment with this drug where the dosing frequency exceeds 40 mg per fortnight will not be approved.
20812	Pharmaceutical benefits that have the forms gemcitabine powder for I.V. infusion 200 mg (as hydrochloride) (after reconstitution), gemcitabine solution concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL and gemcitabine solution for injection 200 mg (as hydrochloride) in 5.3 mL are equivalent for the purposes of substitution.
20813	Pharmaceutical benefits that have the forms gemcitabine powder for I.V. infusion 1 g (as hydrochloride) (after reconstitution), gemcitabine solution concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL and gemcitabine solution for injection 1 g (as hydrochloride) in 26.3 mL are equivalent for the purposes of substitution.
20814	Pharmaceutical benefits that have the form gemcitabine powder for I.V. infusion 2 g (as hydrochloride) (after reconstitution), and pharmaceutical benefits that have the form gemcitabine solution for injection 2 g (as hydrochloride) in 52.6 mL are equivalent for the purposes of substitution.
20959	Pharmaceutical benefits that have the forms fluconazole 200 mg/100 mL injection, 100 mL vial and fluconazole 200 mg/100 mL injection, 100 mL bag are equivalent for the purposes of substitution.
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.
20996	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, and tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg tablet are equivalent for the purposes of substitution.
21092	Pharmaceutical benefits that have the form ceftriaxone 2 g injection, 1 vial and pharmaceutical benefits that have the form ceftriaxone 2 g injection, 5 vials 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.
21202	Increase in the maximum number of repeats of up to two may be authorised in patients whose dosing frequency is every 8 weeks.
21221	OxyContin and Novacodone modified release tablets are intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse.
21226	Pharmaceutical benefits that have the form alprazolam tablet 500 micrograms are equivalent for the purposes of substitution.
21230	Pharmaceutical benefits that have the form alprazolam tablet 1 mg are equivalent for the purposes of substitution.
21233	Applications for authority to prescribe may be made by phone to the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday)
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.
21302	Biosimilar prescribing policy Prescribing of the biosimilar brand Brenzys is encouraged for treatment naive patients.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 Biosimilar Awareness Initiative webpage (www.health.gov.au/biosimilars).
21307	TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE RHEUMATOID ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological disease modifying antirheumatic drugs (bDMARDs) for adults with severe active rheumatoid arthritis. Where the term bDMARD appears in the following notes and restrictions it 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-associated kinase (JAK) inhibitor (tofacitinib).Patients are eligible for PBS-subsidised treatment with only 1 of the above biological disease modifying anti-rheumatic drugs at any 1 time.In order to be eligible to receive PBS-subsidised treatment with rituximab, a patient must have already failed to demonstrate a response to at least 1 course of treatment with a PBS-subsidised TNF-alfa antagonist.A patient receiving PBS-subsidised bDMARD therapy may swap to an alternate bDMARD without having to experience a disease flare. Under these interchangeability arrangements: - a patient may continue to receive long-term treatment with a PBS-subsidised bDMARD while they continue to show a response to therapy,- a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised bDMARD more than once, and - once a patient has either failed or ceased to respond to treatment 5 times, they will not be eligible to receive further PBS-subsidised bDMARDs for the treatment of rheumatoid arthritis.For patients who have failed PBS-subsidised treatment with 2 or 3 TNF-alfa antagonists prior to 1 August 2010 please contact the Department of Human Services on 1800 700 270. A patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, may apply for a further course of rituximab under the Continuing treatment restriction. A patient who has failed fewer than 5 bDMARDs and who has a break in therapy of less than 24 months may commence a further course of treatment with a bDMARD without having to requalify under the Initial 1 treatment restriction. A patient who has failed fewer than 5 bDMARDs and who has had a break in therapy of longer than 24 months must requalify for treatment under the Initial 1 treatment restriction. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised bDMARD treatment is stopped to the date of the new application for treatment with a bDMARD.(1) How to prescribe PBS-subsidised bDMARD therapy after 1 August 2010.(a) Initial treatment. Applications for initial treatment should be made where: (i) a patient has received no prior PBS-subsidised bDMARD treatment and wishes to commence such therapy, excluding rituximab (Initial 1); or (ii) a patient wishes to re-commence treatment with a bDMARD following a break in PBS-subsidised therapy of more than 24 months (Initial 1); or (iii) a patient has received prior PBS-subsidised (initial or continuing) bDMARD therapy and wishes to trial an alternate agent (Initial 2) [further details are under 'Swapping therapy' below]; or (iv) a patient wishes to re-commence treatment with a specific bDMARD following a break of less than 24 months in PBS-subsidised therapy with that agent (Initial 2).Initial applications for new or re-commencing patients (Initial 1) 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.Initial treatment authorisations will be limited to provide a maximum of 16 weeks of therapy for abatacept, adalimumab, etanercept, golimumab, tocilizumab and tofacitinib, 18 to 20 weeks of therapy with certolizumab pegol (depending upon the dosing regimen), 22 weeks of therapy for infliximab and 2 infusions of rituximab.A patient must be assessed for response to any course of initial PBS-subsidised treatment (excluding rituximab) following a minimum of 12 weeks of therapy and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Rituximab patients must be assessed following a minimum of 12 weeks after the first infusion, and this assessment must be submitted to the Department of Human Services within 4 weeks.Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD. For second and subsequent courses of PBS-subsidised bDMARD (excluding rituximab) treatment it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that where required an application is submitted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course.Abatacept patients: Patients are eligible to receive one I.V. loading dose when commencing treatment with the subcutaneous formulation. For these patients two prescriptions are required, the first prescription for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats, must be submitted with the initial application.Rituximab patients: A further application may be submitted to the Department of Human Services 24 weeks after the first infusion. New baselines may be submitted with this application if appropriate.(b) Continuing treatment. Following the completion of an initial treatment course with a specific bDMARD (excluding rituximab), 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 bDMARD 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 bDMARD supply.Rituximab patients: A patient may qualify to receive a further course of treatment (every 24 weeks) with this agent providing they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with rituximab. The patient remains eligible to receive a course of rituximab every 24 weeks providing they continue to demonstrate a response as specified in the restriction. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD.(2) Swapping therapyOnce initial treatment with the first PBS-subsidised bDMARD is approved, a patient may swap to an alternate bDMARD 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 joint count) or the prior non- bDMARD therapy requirements, except if the patient has had a break in therapy of more than 24 months. However the requirement for concomitant treatment with methotrexate, where it applies, must be met for each bDMARD trialled.Patients who are not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that agent.A patient may trial an alternate bDMARD at any time, regardless of whether they are receiving therapy (initial or continuing) with a bDMARD at the time of the application. However, they cannot swap to a particular bDMARD if they have failed to respond to prior treatment with that drug.Abatacept: Patients swapping from I.V. abatacept to subcutaneous abatacept will not be eligible for an I.V. loading dose when commencing treatment with the subcutaneous formulation.Rituximab:In order to trial rituximab, a patient must have trialled and failed to demonstrate a response to at least 1 PBS-subsidised TNF-alfa antagonist treatment.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, within the timeframes specified in the relevant restriction.PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised bDMARD during the required treatment-free period applying to patients who have demonstrated a response to their most recent course of rituximab. This means that patients who have demonstrated a response to a course of rituximab must have a PBS-subsidised bDMARD therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate bDMARD. Patients who fail to respond to rituximab and who qualify and wish to trial a course of an alternate bDMARD may do so without having to have any treatment-free period.To avoid confusion, an application for a patient who wishes to swap to an alternate bDMARD should be accompanied by the prescription or remaining repeats for the bDMARD the patient is ceasing.(3) 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 joint count, ESR and/or CRP submitted with the first authority application for a bDMARD. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted and the Department of Human Services will assess response according to these revised baseline measurements.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 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 will 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 demonstrated on the total number of major joints.Except as specified under the Initial 1 treatment restriction, a baseline joint count and ESR and/or CRP should be performed whilst the patient is still on treatment or within 1 month of ceasing prior treatment. Applications under the Initial 1 treatment restriction for new or re-commencing patients 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.
21347	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).
21351	TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, certolizumab pegol, etanercept, golimumab, infliximab and secukinumab for adult patients with active ankylosing spondylitis.Where the term bDMARD appears in notes and restrictions, it refers to adalimumab, certolizumab pegol, etanercept, golimumab, infliximab and secukinumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the 6 bDMARDs at any 1 time.Under these interchangeability arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a bDMARD while they continue to show a response to therapy.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised bDMARD 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 bDMARD 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 bDMARD treatment in the most recent cycle to the date of the first application for initial treatment with a bDMARD under the new treatment cycle.A patient who has failed fewer than 3 bDMARDs 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 bDMARDs 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 bDMARD therapy (a) Initial treatment. Applications for initial treatment should be made where: (i) a patient has received no prior PBS-subsidised bDMARD treatment in this treatment cycle and wishes to commence such therapy (Initial 1); or(ii) a patient has received prior PBS-subsidised (initial or continuing) bDMARD therapy and wishes to trial an alternate agent (Initial 2) [further details are under 'Swapping therapy' below]; or (iii) a patient wishes to re-commence treatment with a specific bDMARD following a break in PBS-subsidised therapy with that agent (Initial 1 for recommencement after 5 years or more and initial 2 for recommencement after a break of less than 5 years).A patient must be assessed for response to any course of initial PBS-subsidised treatment following a minimum of 12 weeks of therapy and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that bDMARD.For second and subsequent courses of PBS-subsidised bDMARD treatment, it is recommended that a patient is reviewed in the month prior to completing their current course of treatment.(b) Continuing treatment. Following the completion of an initial treatment course with a specific bDMARD, 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 bDMARD 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 month prior to completing their current course of treatment to ensure uninterrupted bDMARD supply.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised bDMARD is approved, a patient may swap to an alternate bDMARD 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 bDMARD at any time, regardless of whether they are receiving therapy (initial or continuing) with a bDMARD at the time of the application. However, they cannot swap to a particular bDMARD 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.To avoid confusion, an application for a patient who wishes to swap to an alternate bDMARD should be accompanied by the prescription or remaining repeats for the bDMARD the patient is ceasing.(3) 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 BASDAI, ESR and/or CRP submitted with the first authority application for a bDMARD.However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and the Department of Human Services will assess response according to these revised baseline measurements.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 at the commencement of treatment with each initial treatment application 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.(4) Re-commencement 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 bDMARD therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity. Patients must have received treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months immediately prior to the time the BASDAI, ESR and/or CRP levels are measured.
21373	Pharmaceutical benefits that have the form alprazolam tablet 250 micrograms are equivalent for the purposes of substitution.
21391	TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE PSORIATIC ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological agents adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab and ustekinumab for adult patients with severe active psoriatic arthritis.Patients are eligible for PBS-subsidised treatment with only 1 of the above biological agents at any 1 time.Where the term 'biological agents' appears in notes and restrictions, it refers to adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab and ustekinumab only.Patients receiving PBS-subsidised treatment for psoriatic arthritis are able to commence a 'Biological Treatment Cycle' (Cycle), where they may trial biological agents without having to experience a disease flare when swapping to the alternate agent. Under these interchangeability arrangements, within a single Cycle, patients may receive long-term treatment with a biological agent as long as they sustain a response to therapy.Following demonstration of response to initial treatment, these biological agents are available under the PBS for continuing treatment as set out in the continuing treatment restrictions for each agent.Once patients have 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 therapy before they are eligible to commence another Cycle [further details are under '(5) Re-commencement 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 issued in the most recent Cycle to the date of the first application for initial treatment with a biological agent under the new Cycle.Within the same Cycle, patients are not allowed to fail, or cease to respond to, the same PBS-subsidised biological agent more than once. Therefore once a patient fails to meet the response criteria for any biological agent, they must change to an alternate agent which they have not previously failed, if they wish to continue PBS-subsidised biological treatment.Patients for whom a break in PBS-subsidised therapy of less than 5 years has occurred, and, who have failed therapy fewer than 3 times within a particular treatment Cycle, as defined in the relevant restriction, may commence a further course of treatment within that Cycle (Initial 2).Patients for whom a break in PBS-subsidised therapy of 5 years or more has occurred are eligible to commence a new Cycle (Initial 1).There is no limit to the number of Biological Treatment Cycles a patient may undertake in their lifetime.How to prescribe biological agents for the treatment of severe active psoriatic arthritis.(1) Initial treatment.Applications for initial treatment should be made where:(i) patients have received no prior PBS-subsidised biological treatment and wish to commence such therapy (Initial 1); and(ii) patients have received prior PBS-subsidised biological therapy and wish to trial an alternate agent (Initial 2) [further details are under 'Swapping therapy' below]; and(iii) patients wish to re-commence treatment with a specific biological agent following a break in PBS-subsidised therapy with that specific agent (Initial 1 or Initial 2).All applications for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, etanercept, golimumab and secukinumab, 18 to 20 weeks of therapy for certolizumab pegol (depending upon the dosing regimen), 22 weeks of therapy for infliximab, and 28 weeks of therapy for ustekinumab. It is recommended that patients be reviewed in the month prior to completing their course of initial treatment to ensure uninterrupted biological agent supply.Patients must be assessed for response to any course of PBS-subsidised initial treatment following a minimum of 12 weeks of therapy and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted within these timeframes, patients will be deemed to have failed to respond to treatment with that biological agent.(2) Continuing treatment.Following the completion of an initial treatment course with a specific biological agent, patients may qualify to receive up to 24 weeks of continuing treatment with that drug providing they have demonstrated an adequate response to treatment.Patients are eligible to receive continuing biological treatment with the same drug in courses of up to 24 weeks providing they continue to sustain the response.Patients must be assessed for response to a course of continuing therapy, and the assessment must be submitted to the Department of Human Services where applicable. Where a response assessment is not submitted where applicable, patients will be deemed to have failed to respond to treatment with that biological agent.(3) Swapping therapy.Once an authority for initial treatment with the first PBS-subsidised biological agent is approved, patients may swap to an alternate biological agent 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.Patients may swap to an alternate biological agent at any time, regardless of whether they are receiving therapy (initial or continuing) with a biological agent at the time of the application or not.Within a Treatment Cycle patients may alternate between therapy with any biological agent of their choice (1 at a time) providing:(i) they have not received PBS-subsidised treatment with that particular biological agent previously; or(ii) they have demonstrated an adequate response to that particular biological agent 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.To ensure patients receive the maximum treatment opportunities allowed under the interchangeability arrangements, it is important that they are assessed for response to every course of treatment within the timeframes specified in the relevant restriction.To avoid confusion, applications for patients who wish to swap to an alternate biological agent should be accompanied by the authority prescription or remaining repeats for the biological agent the patient is ceasing.(4) Baseline measurements to determine response.Determination of whether a response to treatment has been demonstrated will be based on the baseline measurements of the indices of disease severity submitted with the first authority application for a biological agent. However, prescribers may provide new baseline measurements any time that an initial treatment application is submitted within a treatment Cycle and these revised baseline measurements will be used to assess response.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.Patients who wish to trial a second or subsequent treatment Cycle following a break in PBS-subsidised biological therapy of at least 5 years must requalify for initial treatment with respect to both the indices of disease severity. Patients must have re-trialled treatment with methotrexate and sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months at the time the ESR or CRP levels and the active joint counts are measured.
21431	Authority approvals will be limited to a maximum quantity of 2 auto-injectors at any one time.
21439	A PASI assessment of the patient's response must be conducted within 4 weeks prior to completion of this course of treatment. This assessment, which will be used to determine eligibility for continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this course of treatment. Where a response assessment is not undertaken and submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.In circumstances where it is not possible to submit a response assessment within these timeframes, please call the Department of Human Services on 1800 700 270 to discuss.
21501	No increase in the maximum amount or number of units may be authorised.
21554	Pharmaceutical benefits that have the form tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg and pharmaceutical benefits that have the form tablet containing abacavir 600 mg (as hydrochloride) with lamivudine 300 mg are equivalent for the purposes of substitution.
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.
21975	Diagnosis of COPD should be confirmed with spirometry.
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, beclomethasone 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.
22064	This product is not PBS-subsidised for the treatment of asthma or the initiation of bronchodilator therapy in COPD.
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).
22081	This drug is not PBS-subsidised for use as monotherapy or in combination with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), an SGLT2 inhibitor, an insulin or a sulfonylurea as dual therapy.
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.
22215	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 criterion for PBS-subsidised treatment with this drug.
22216	Biosimilar preferred prescribing policyPrescribing of the biosimilar brand Inflectra or Renflexis is encouraged for treatment naive patients.
22217	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 Biosimilar Awareness Initiative webpage (www.health.gov.au/biosimilars).
22240	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 adalimumab, infliximab, vedolizumab or ustekinumab 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, infliximab, vedolizumab or ustekinumab while they continue to show a response to therapy.A patient who received PBS-subsidised adalimumab, infliximab, or vedolizumab treatment 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 adalimumab, infliximab, vedolizumab or ustekinumab 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 adalimumab, infliximab, vedolizumab or ustekinumab treatment in the most recent cycle to the date of the first application for initial treatment with adalimumab, infliximab, vedolizumab or ustekinumab 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 therapy with adalimumab, infliximab, vedolizumab or ustekinumab in this treatment cycle and wishes to commence such therapy (Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1)); or(ii) a patient has received prior PBS-subsidised (initial or continuing) adalimumab, infliximab, vedolizumab or ustekinumab and wishes to trial an alternate agent (Initial 2 - Change or recommencement) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to re-commence treatment with adalimumab, infliximab, vedolizumab or ustekinumab following a break in PBS-subsidised therapy with that agent (Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)).Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, 14 weeks of therapy for infliximab, 14 weeks of therapy for vedolizumab and 16 weeks for ustekinumab.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 for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab or vedolizumab, and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine.For subsequent courses of PBS-subsidised adalimumab, infliximab, vedolizumab or ustekinumab treatment, it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that where required an application is submitted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course.Adalimumab only: Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be for the induction pack 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 40 kg or greater. 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.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.(b) Continuing treatment.Following the completion of an initial treatment course with adalimumab, infliximab, vedolizumab or ustekinumab, 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 month prior to completing their current course of treatment to ensure uninterrupted supply 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 adalimumab, infliximab, vedolizumab or ustekinumab 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 adalimumab, infliximab, vedolizumab or ustekinumab 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.(3) 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 CDAI or evidence of intestinal inflammation submitted with the first authority application for adalimumab, infliximab, vedolizumab or ustekinumab. However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and the Department of Human Services will assess response according to these revised baseline measurements.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 assess response to all subsequent treatments.(4) Re-commencement 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. Patients must have received treatment with a corticosteroid and at least 1 immunosuppressive agent, at an adequate dose, for a minimum of 3 consecutive months immediately prior to the time the CDAI score or the indices of intestinal inflammation are measured.(5) Patients 'grandfathered' onto PBS-subsidised treatment with vedolizumab.A patient who commenced treatment with vedolizumab for severe Crohn disease prior to 1 August 2015 and who continues to receive treatment at the time of application may qualify for treatment under the initial 'grandfather' treatment restriction.A patient may only qualify for PBS-subsidised treatment under this criterion once. A maximum of 24 weeks of treatment will be authorised under this criterion.Following completion of the initial PBS-subsidised course, further applications for treatment will be assessed under the continuing treatment restriction of the relevant drug.'Grandfather' arrangements will only apply for the first treatment cycle. For the second and subsequent cycles, a 'grandfather' patient must requalify for continuing treatment under the criteria that apply to a new patient. See 'Re-commencement of treatment after a 5-year break in PBS-subsidised therapy' above for further details.(6) Patients 'grandfathered' onto PBS-subsidised treatment with ustekinumab.A patient who commenced treatment with ustekinumab for severe Crohn disease prior to 1 September 2017 and who continues to receive treatment at the time of application may qualify for treatment under the initial 'grandfather' treatment restriction.A patient may only qualify for PBS-subsidised treatment under this criterion once. A maximum of 24 weeks of treatment will be authorised under this criterion.Following completion of the initial PBS-subsidised course, further applications for treatment will be assessed under the continuing treatment restriction of the relevant drug.'Grandfather' arrangements will only apply for the first treatment cycle. For the second and subsequent cycles, a 'grandfather' patient must requalify for continuing treatment under the criteria that apply to a new patient. See 'Re-commencement of treatment after a 5-year break in PBS-subsidised therapy' above for further details.
22271	Biosimilar prescribing policy Prescribing of the biosimilar brand, Bemfola, is encouraged for treatment naive patients.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 Biosimilar Awareness Initiative webpage (www.health.gov.au/biosimilars).
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.
22343	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 treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1); 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) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to re-commence treatment with adalimumab or infliximab following a break in PBS-subsidised therapy with that agent (Change or Re-commencement of treatment after a break in therapy of less than 5 years (Initial 2)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 submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine.For subsequent courses of PBS-subsidised adalimumab or infliximab treatment, it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that where required an application is submitted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course.Adalimumab only: Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.(b) Continuing treatment.Following the completion of an initial treatment course with adalimumab or infliximab, 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 month prior to completing their current course of treatment to ensure uninterrupted supply 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.(3) 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 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 Department of Human Services will assess response according to these revised baseline measurements.(4) Re-commencement 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.
22351	A maximum number of repeats of up to 2 may be authorised for patients requiring loading doses for days 14, 28 and 63.
22352	A maximum number of repeats of up to 1 may be authorised for patients requiring loading doses for days 28 and 63.
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.
22437	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. For paediatric patients with Crohn disease, infliximab is PBS-subsidised for moderate to severe disease while adalimumab is PBS-subsidised for severe disease.From 1 August 2015, under the PBS, patients commencing on adalimumab 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 infliximab. Patients on infliximab will be able to commence a treatment cycle where they may trial each PBS-subsidised biological medicine but will need to meet a PCDAI score of greater than or equal to 40 when swapping to adalimumab. 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 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.(1) How to prescribe PBS-subsidised biological medicine therapy after 1 August 2015.(a) 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 treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ); or(ii) a patient has received prior PBS-subsidised (initial or continuing) biological medicine therapy and wishes to trial an alternate agent - Initial 2 treatment (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 treatment (Change or Re-commencement of treatment after a break in therapy 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 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 submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine.For first and subsequent continuing courses of PBS-subsidised biological medicine therapy, it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that where required an application is submitted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course.Adalimumab only: Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be for the induction pack 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 40 kg or greater. 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.(b) 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 be reviewed in the month prior to completing their current course of treatment to ensure uninterrupted supply of treatment.(2) 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. Patients on infliximab may swap to adalimumab within the same treatment cycle provided that their disease severity has progressed to severe disease (i.e. they have a current PCDAI score of 40 or more).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.(3) 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 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 the Department of Human Services will assess response according to these revised baseline measurements.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 assess response to all subsequent treatments.(4) Re-commencement 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.Patients must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months immediately prior to the time the PCDAI score is measured.
22470	Not for use in vulvovaginal candida infections.
22506	The Australian Absolute Cardiovascular Disease Risk Calculator is available at www.cvdcheck.org.au
22570	TREATMENT OF ADULT AND ADOLESCENT PATIENTS WITH UNCONTROLLED SEVERE EOSINOPHILIC ASTHMAPatients are eligible to commence a 'benralizumab 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 benralizumab, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 6 month break in PBS-subsidised benralizumab therapy before they are eligible to commence the next 'benralizumab treatment cycle', or if eligible, a 'mepolizumab treatment cycle' or an 'omalizumab treatment cycle'. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised benralizumab is stopped to the date of the first application for initial treatment with benralizumab, mepolizumab or 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 benralizumab therapy:(a) Initial treatment:Applications for initial treatment should be made where:i) A patient has received no prior PBS-subsidised benralizumab treatment and wishes to commence such therapy; orii) A patient wishes to recommence treatment with benralizumab following a break in PBS-subsidised therapy of more than 6 months; oriii) A patient has received prior PBS-subsidised mepolizumab or omalizumab and wishes to commence treatment with benralizumab after a treatment break of 6 months.All applications for initial treatment for non-grandfather patients will be limited to provide for a maximum of up to 32 weeks of therapy for benralizumab.(b) Grandfather patients:For patients who commenced treatment with non-PBS subsidised benralizumab for uncontrolled severe eosinophilic asthma prior to 1 December 2018 and who continue to receive treatment at the time of application, may qualify for treatment under the initial 'grandfather' treatment restriction. A patient may only qualify for PBS-subsidised treatment under this restriction once. A maximum of 24 weeks of treatment with benralizumab will be authorised under this criterion. Approval will be based on the criteria included in the relevant restriction. Following completion of the Initial PBS-subsidised course, further applications for treatment with benralizumab will be assessed under the continuing treatment restriction.'Grandfather' arrangements will only apply for the first treatment cycle (initial treatment course with or without continuing treatment course/s). If a 'Grandfathered' patient recommences on second and subsequent cycles after a treatment break, the 'Grandfathered' patient must re-qualify for Initial treatment under the criteria that apply to a new patient. See 'Re-commencement of treatment after a 6 month break in PBS-subsidised therapy' below for further details.(c) Continuing treatment:Following the completion of the initial treatment course with benralizumab, a patient may qualify to receive up to a further 24 weeks of continuing treatment with benralizumab providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing benralizumab 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 oral corticosteroid dose, submitted with the Initial authority application for benralizumab. 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 benralizumab treatment cycle, or an initial mepolizumab or omalizumab treatment cycle, following a break in PBS-subsidised therapy of at least 6 months, must re-qualify for initial treatment with respect to the indices of disease severity (oral corticosteroid dose, Asthma Control Questionnaire (ACQ-5) score, 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.
22579	For copies of the ACQ, please contact AstraZeneca Medical Information on 1800 805 342.
22584	Authority approval for sufficient therapy to complete a maximum of 32 weeks of treatment under the initial 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).
22602	TREATMENT OF ADULT AND ADOLESCENT PATIENTS WITH UNCONTROLLED SEVERE EOSINOPHILIC ASTHMAPatients are eligible to commence a 'mepolizumab 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 mepolizumab, they are deemed to have completed a treatment cycle and they must have, at a minimum, a 6 month break in PBS-subsidised mepolizumab therapy before they are eligible to commence the next mepolizumab treatment cycle, or if eligible, a 'benralizumab treatment cycle' or an 'omalizumab treatment cycle'. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised mepolizumab is stopped to the date of the first application for initial treatment with benralizumab, mepolizumab or 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 mepolizumab therapy:(a) Initial treatment:Applications for initial treatment should be made where:i) A patient has received no prior PBS-subsidised mepolizumab treatment and wishes to commence such therapy; orii) A patient wishes to recommence treatment with mepolizumab following a break in PBS-subsidised therapy of more than 6 months; oriii) A patient has received prior PBS-subsidised benralizumab or omalizumab and wishes to commence treatment with mepolizumab after a treatment break of 6 months.All applications for initial treatment will be limited to provide for a maximum of up to 32 weeks of therapy for mepolizumab.(b) Continuing treatment:Following the completion of the initial treatment course with mepolizumab, a patient may qualify to receive up to a further 24 weeks of continuing treatment with mepolizumab providing they have demonstrated an adequate response to treatment. The patient remains eligible to receive continuing mepolizumab 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 oral corticosteroid dose, submitted with the Initial authority application for mepolizumab. 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 mepolizumab treatment cycle, or an initial benralizumab or omalizumab treatment cycle, following a break in PBS-subsidised therapy of at least 6 months, must re-qualify for initial treatment with respect to the indices of disease severity (oral corticosteroid dose, Asthma Control Questionnaire (ACQ-5) score, 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.
22606	TREATMENT OF ADULT AND ADOLESCENT 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 omalizumab treatment cycle or, if eligible, a 'benralizumab treatment cycle' or a 'mepolizumab treatment cycle'. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised omalizumab is stopped to the date of the first application for initial treatment with benralizumab, omalizumab or mepolizumab 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:i) A patient has received no prior PBS-subsidised omalizumab treatment and wishes to commence such therapy; orii) A patient wishes to recommence treatment with omalizumab following a break in PBS-subsidised therapy of at least 6 months; oriii) A patient has received prior PBS-subsidised benralizumab or mepolizumab and wishes to commence treatment with omalizumab after a treatment break of at least 6 months.All applications for initial treatment will be limited to provide for a maximum of up to 28 weeks of therapy of 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 oral corticosteroid dose submitted with the Initial authority application for omalizumab. 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 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 omalizumab treatment cycle, or an initial benralizumab or mepolizumab treatment cycle, following a break in PBS-subsidised therapy of at least 6 months, must re-qualify for initial treatment with respect to the indices of disease severity (oral corticosteroid dose, Asthma Control Questionnaire (ACQ-5) score, 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.
22705	Patient must be aged 18 years or older.
22706	Patient must be aged 12 years or over.
22714	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. Infliximab and adalimumab are PBS-subsidised for moderate to severe disease while only infliximab is PBS-subsidised for acute severe disease.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.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. 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. 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 therapy after 1 June 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 treatment (new patient or Recommencement of treatment after more than 5 years break in therapy); or(ii) a patient has received prior PBS-subsidised (initial or continuing) treatment with a biological medicine and wishes to trial an alternate agent - Initial 2 treatment (Change or Re-commencement of treatment after a break in therapy of less than 5 years ) [further details are under 'Swapping treatment' 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 treatment (Change or Re-commencement of treatment after a break in therapy of less than 5 years ).Treatment authorisations under Initial 1 and Initial 2 treatment 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. For second and subsequent courses of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed in the month prior to completing their current course of treatment.Adalimumab only: Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater, one prescription should be for the induction pack 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.(b) 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 continuing treatment restriction providing they continue to sustain the response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment to ensure PBS subsidy criteria are met.(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 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) with infliximab or adalimumab 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.(3) Re-commencement 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. A patient must have received treatment with a 5-aminosalicylate oral preparation in a standard dose for induction of remission for a minimum of 3 consecutive months, and, either azathioprine or 6-mercaptopurine for a minimum of 3 consecutive months or a tapered course of oral steroids over a 6 week period followed by an appropriately dosed thiopurine agent for a minimum of 3 consecutive months (unless intolerance develops necessitating permanent treatment withdrawal to these agents) immediately prior to the time the PUCAI score is measured.
22741	Managed Access Program:This medicine has been listed on the PBS via a Managed Access Program (MAP). The Pharmaceutical Benefits Advisory Committee (PBAC) made its recommendation on the basis of 24 weeks of data in children aged 6 - 11 years and 96 weeks of data in patients aged 12 years and over. Information about the long term benefits of this medicine will be collected and analysed under this MAP.For more information on Managed Access Programs, please visit http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes/2015-03/march-2015-other-matters-managed-access-programme-framewk.
22756	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 and vedolizumab for adult patients with ulcerative colitis. Patients are eligible for PBS-subsidised treatment with either adalimumab, golimumab, infliximab or vedolizumab at any one time.Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, golimumab, infliximab and vedolizumab only.From 1 June 2018, under the PBS, all adult patients will be able to commence a treatment cycle where they may trial PBS-subsidised adalimumab, golimumab, infliximab or vedolizumab 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 adalimumab, golimumab, infliximab or vedolizumab while they continue to show a response to therapy.A patient who received PBS-subsidised adalimumab, infliximab, vedolizumab treatment prior to 1 June 2018 is considered to start their first cycle as of 1 June 2018. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised adalimumab, golimumab, infliximab or vedolizumab 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 adalimumab, golimumab, infliximab or vedolizumab treatment in the most recent cycle to the date of the first application for initial treatment with adalimumab, golimumab, infliximab or vedolizumab under the new treatment cycle.A patient who has failed fewer than 3 trials of either adalimumab, golimumab, infliximab or vedolizumab in a treatment cycle and who has a break in therapy of more than 5 years, may commence a new treatment cycle.(1) How to prescribe PBS-subsidised treatment with adalimumab, golimumab, infliximab and vedolizumab after 1 June 2018.(a) Initial treatment. Applications for initial treatment should be made where:(i) an adult patient has received no prior PBS-subsidised treatment with adalimumab, golimumab, infliximab or vedolizumab in this treatment cycle and wishes to commence such therapy (Initial 1 - New patient or recommencement of treatment after more than 5 years break in therapy); or(ii) an adult patient has received prior PBS-subsidised (initial or continuing) adalimumab, golimumab, infliximab or vedolizumab 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) an adult patient wishes to re-commence treatment with adalimumab, golimumab, infliximab or vedolizumab following a break in PBS-subsidised therapy with the same agent (Initial 2 - Change or Re-commencement of treatment after a break in therapy of less than 5 years).Treatment authorisations under Initial 1 and Initial 2 will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, 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 and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab. For second and subsequent courses of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed in the month prior to completing their current course of treatment.(b) Continuing treatment.Following the completion of an initial treatment course with adalimumab, golimumab, infliximab or vedolizumab 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 month prior to completing their current course of treatment.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised treatment is approved, a patient may swap if eligible to the alternate adalimumab, golimumab, infliximab or vedolizumab 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 treatment at any time, regardless of whether they are receiving therapy (initial or continuing) with adalimumab, golimumab, infliximab or vedolizumab at the time of the application. However, they cannot swap to a particular therapy 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.(3) 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 adalimumab, golimumab, infliximab or vedolizumab therapy of at least 5 years, must requalify for initial 1 treatment with respect to the scores of disease severity. A patient must have received treatment with a 5-aminosalicylate oral preparation in a standard dose for induction of remission for a minimum of 3 consecutive months, and, either azathioprine or 6-mercaptopurine for a minimum of 3 consecutive months or a tapered course of oral steroids over a 6 week period followed by an appropriately dosed thiopurine agent for a minimum of 3 consecutive months (unless intolerance develops necessitating permanent treatment withdrawal to these agents). These above prior treatments must have been received immediately prior to the time the scores of disease severity being used to trial a second or subsequent course are measured.(4) Patients 'grandfathered' onto PBS-subsidised treatment with golimumab.A patient who commenced treatment with golimumab for moderate to severe ulcerative colitis prior to 1 June 2018 and who continues to receive treatment at the time of application, may qualify for treatment under the initial 3 'grandfather' treatment restriction.A patient may only qualify for PBS-subsidised treatment under this criterion once. A maximum of 24 weeks of treatment will be authorised under this criterion. Following completion of the initial PBS-subsidised course, further subsidised treatment must be prescribed under the continuing treatment restriction of the relevant drug. 'Grandfather' arrangements will only apply for the first treatment cycle.For the second and subsequent cycles, a 'grandfather' patient must qualify for continuing treatment under the criteria that apply to a continuing patient.
22813	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 and secukinumab 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 and secukinumab only.A patient is eligible for PBS-subsidised treatment with only 1 of the 6 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.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 and secukinumab.(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 recommencement of treatment after more than 5 years break in therapy); or(ii) a patient wishes to re-commence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 1 - New patient or recommencement of treatment after more than 5 years break in therapy); or(iii) 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(iv) a patient wishes to re-commence 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 Re-commencement of treatment after a break in therapy of less 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.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 in the month prior to completing their current course of 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.(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.(3) 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 BASDAI, 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 within a treatment cycle and the Department of Human Services will assess response according to these revised baseline measurements.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 at the commencement of treatment with each initial treatment application 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.(4) 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 medicine therapy of at least 5 years, must requalify for initial 1 treatment with respect to the indices of disease severity. A patient must have received treatment with at least 1 NSAID, at an adequate dose, for a minimum of 3 consecutive months immediately prior to the time the BASDAI, ESR and/or CRP levels are measured.
22835	TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE RHEUMATOID ARTHRITISThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) 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 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).Patients are eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.In order to be eligible to receive PBS-subsidised treatment with rituximab, a patient must have already failed to demonstrate a response to at least 1 course of treatment with a PBS-subsidised TNF-alfa antagonist.A patient receiving PBS-subsidised biological medicine therapy may swap to an alternate biological medicine without having to experience a disease flare. Under these interchangeability arrangements:- 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 cannot trial and fail, or cease to respond to, the same PBS-subsidised biological medicine more than once, and- once a patient has either failed or ceased to respond to treatment 5 times, they will not be eligible to receive further PBS-subsidised biological medicines for the treatment of rheumatoid arthritis.For patients who have failed PBS-subsidised treatment with 2 or 3 TNF-alfa antagonists prior to 1 August 2010 please contact the Department of Human Services on 1800 700 270. A patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, may apply for a further course of rituximab under the Continuing treatment restriction. A patient who has failed fewer than 5 biological medicines and who has a break in therapy of less than 24 months may commence a further course of treatment with a biological medicine without having to requalify under the Initial 1 treatment restriction. A patient who has failed fewer than 5 biological medicines and who has had a break in therapy of longer than 24 months must requalify for treatment under the Initial 1 treatment restriction. The length of a treatment break is measured from the date the most recent treatment with PBS-subsidised biological medicine treatment is stopped to the date of the new application for treatment with a biological medicine.(1) How to prescribe PBS-subsidised biological medicine therapy after 1 August 2010.(a) Initial treatment.Applications for initial treatment should be made where:(i) a patient has received no prior PBS-subsidised biological medicine treatment and wishes to commence such therapy, excluding rituximab (Initial 1 - new patient or patient recommencing treatment after a break of more than 24 months); or(ii) a patient wishes to re-commence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 24 months (Initial 1 - new patient or patient recommencing treatment after a break of more than 24 months); or(iii) 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 of less than 24 months) [further details are under 'Swapping therapy' below]; or(iv) a patient wishes to re-commence treatment with a specific biological medicine following a break of less than 24 months in PBS-subsidised therapy with that agent (Initial 2 - change or re-commencement of treatment after a break of less than 24 months).Initial applications for new or re-commencing patients (Initial 1 - new patient or patient recommencing treatment after a break of more than 24 months) 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.Initial treatment authorisations will be limited to provide a maximum of 16 weeks of therapy for abatacept, adalimumab, baricitinib, etanercept, golimumab, tocilizumab and tofacitinib, 18 to 20 weeks of therapy with certolizumab pegol (depending upon the dosing regimen), 22 weeks of therapy for infliximab and 2 infusions of rituximab.A patient must be assessed for response to any course of initial PBS-subsidised treatment (excluding rituximab) following a minimum of 12 weeks of therapy and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased. Rituximab patients must be assessed following a minimum of 12 weeks after the first infusion, and this assessment must be submitted to the Department of Human Services within 4 weeks.Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine. For second and subsequent courses of PBS-subsidised biological medicine (excluding rituximab) treatment it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that where required an application is submitted to the Department of Human Services no later than 2 weeks prior to the patient completing their current treatment course.Abatacept patients:Patients are eligible to receive one I.V. loading dose when commencing treatment with the subcutaneous formulation. For these patients two prescriptions are required, the first prescription for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats, must be submitted with the initial application.Rituximab patients:A further application may be submitted to the Department of Human Services 24 weeks after the first infusion. New baselines may be submitted with this application if appropriate.(b) Continuing treatment.Following the completion of an initial treatment course with a specific biological medicine (excluding rituximab), 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 the month prior to completing their current course of treatment to ensure uninterrupted biological medicine supply.Rituximab patients:A patient may qualify to receive a further course of treatment (every 24 weeks) with this agent providing they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with rituximab. The patient remains eligible to receive a course of rituximab every 24 weeks providing they continue to demonstrate a response as specified in the restriction. Where a response assessment is not submitted to the Department of Human Services within these timeframes, the patient will be deemed to have failed to respond to treatment with that biological medicine.(2) Swapping therapyOnce 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. the erythrocyte sedimentation rate (ESR), the C-reactive protein (CRP) levels and the joint count) or the prior non- biological medicine therapy requirements, except if the patient has had a break in therapy of more than 24 months. However the requirement for concomitant treatment with methotrexate, where it applies, must be met for each biological medicine trialled.Patients who are not able to complete a minimum of 12 weeks of an initial treatment course will be deemed to have failed treatment with that agent.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.Abatacept:Patients swapping from I.V. abatacept to subcutaneous abatacept will not be eligible for an I.V. loading dose when commencing treatment with the subcutaneous formulation.Rituximab:In order to trial rituximab, a patient must have trialled and failed to demonstrate a response to at least 1 PBS-subsidised TNF-alfa antagonist treatment.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, within the timeframes specified in the relevant restriction.PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised biological medicine during the required treatment-free period applying to patients who have demonstrated a response to their most recent course of rituximab. This means that patients who have demonstrated a response to a course of rituximab must have a PBS-subsidised biological medicine therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. Patients who fail to respond to rituximab and who qualify and wish to trial a course of an alternate biological medicine may do so without having to have any treatment-free period.(3) 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 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 Department of Human Services will assess response according to these revised baseline measurements.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 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 will 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 demonstrated on the total number of major joints.Except as specified under the Initial 1 treatment restriction, a baseline joint count and ESR and/or CRP should be performed whilst the patient is still on treatment or within 1 month of ceasing prior treatment. Applications under the Initial 1 treatment restriction for new or re-commencing patients 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.
22905	Following completion of the initial PBS subsidised course, further applications for treatment will be assessed under the continuing treatment restriction.
22951	Pharmaceutical benefits that have the form methotrexate Injection 7.5 mg/0.15 mL pre-filled syringe and pharmaceutical benefits that have the form methotrexate Injection 7.5 mg/0.3 mL pre-filled syringe are equivalent for the purposes of substitution.
22952	Pharmaceutical benefits that have the form methotrexate Injection 10 mg/0.2 mL pre-filled syringe and pharmaceutical benefits that have the form methotrexate Injection 10 mg/0.4 mL pre-filled syringe are equivalent for the purposes of substitution.
22953	Pharmaceutical benefits that have the form methotrexate Injection 15 mg/0.3 mL pre-filled syringe and pharmaceutical benefits that have the form methotrexate Injection 15 mg/0.6 mL pre-filled syringe are equivalent for the purposes of substitution.
22954	Pharmaceutical benefits that have the form methotrexate Injection 20 mg/0.4 mL pre-filled syringe and pharmaceutical benefits that have the form methotrexate Injection 20 mg/0.8 mL pre-filled syringe are equivalent for the purposes of substitution.
22955	Pharmaceutical benefits that have the form methotrexate Injection 25 mg/0.5 mL pre-filled syringe and pharmaceutical benefits that have the form methotrexate Injection 25 mg/mL pre-filled syringe are equivalent for the purposes of substitution.
22996	Pharmaceutical benefits that have the form deferasirox 250 mg dispersible tablet and pharmaceutical benefits that have the form deferasirox 180 mg film coated tablet are equivalent for the purposes of substitution.
22997	Pharmaceutical benefits that have the form deferasirox 500 mg dispersible tablet and pharmaceutical benefits that have the form deferasirox 360 mg film coated tablet are equivalent for the purposes of substitution.
23000	Pharmaceutical benefits that have the form deferasirox 125 mg dispersible tablet and pharmaceutical benefits that have the form deferasirox 90 mg film coated tablet are equivalent for the purposes of substitution.
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.
23085	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, infliximab, secukinumab and ustekinumab for adult patients with severe active psoriatic arthritis.A patient is eligible for PBS-subsidised treatment with only 1 of the above biological medicines at any 1 time.Where the term 'biological medicine' appears in notes and restrictions, it refers to adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, secukinumab and ustekinumab only.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 may continue to receive long-term treatment with a PBS-subsidised biological medicine while they continue to show a response to therapy,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) Re-commencement 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 issued in the most recent cycle to the date of the first application for initial treatment with a biological medicine under the new cycle.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.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.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.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 recommencement of treatment after more than 5 years break in therapy); or(ii) a patient wishes to re-commence treatment with a biological medicine following a break in PBS-subsidised therapy of more than 5 years (Initial 1 - New patient or recommencement of treatment after more than 5 years break in therapy): or(iii) a patient has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate medicine (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(iv) a patient wishes to re-commence 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 Re-commencement of treatment after a break in therapy of less than 5 years).An application for initial treatment will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, etanercept and golimumab and secukinumab, 18 to 20 weeks of therapy for certolizumab pegol (depending upon the dosing regimen), 22 weeks of therapy for infliximab, and 28 weeks of therapy for ustekinumab. 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.A patient must be assessed for response to a course of PBS-subsidised initial treatment following a minimum of 12 weeks of therapy.(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.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.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to the Department of Human Services 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.For second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed in the month prior to completing their current 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.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 a biological medicine.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.The Department of Human Services will determine whether a response to treatment has been demonstrated based on 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 treatment application is submitted within a treatment cycle and these revised baseline measurements will be used to assess response.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 requalify for Initial 1 treatment with respect to both the indices of disease severity. A patient must have received treatment with methotrexate and sulfasalazine or leflunomide, at an adequate dose, for a minimum of 3 months at the time the ESR or CRP levels and the active joint counts are measured.
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.
23214	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, infliximab, ixekizumab, secukinumab, 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, infliximab, ixekizumab, secukinumab, 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 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.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 issued 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.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.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 and wishes to commence such therapy (Initial 1 - New patient or recommencement of treatment after more than 5 years break in therapy); 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 1 - New patient or recommencement of treatment after more than 5 years break in therapy); or(iii) a patient who has received prior PBS-subsidised biological medicine therapy (initial or continuing) and wishes to trial an alternate biological medicine (Initial 2 - Change or Re-commencement of treatment after a break in therapy 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 Re-commencement of treatment after a break in therapy of less 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, 22 weeks of therapy for infliximab and 28 weeks of therapy for ustekinumab.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) Assessment of response to initial treatment.When prescribing initial treatment with a biological medicine a PASI assessment must be conducted after at least 12 weeks of treatment. This assessment must be conducted within 1 month of 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.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.A patient must be assessed for response to a course of continuing therapy, and the assessment must be submitted to the Department of Human Services 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.For second and subsequent continuing courses of PBS-subsidised biological medicine treatment, it is recommended that a patient is reviewed in the month prior to completing their current 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.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.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.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.The Department of Human Services will determine whether a response to treatment has been 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/recommencement treatment application is submitted within a treatment cycle and this revised baseline PASI score will be used to assess subsequent responses.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 course of treatment following a break in PBS-subsidised biological therapy of at least 5 years, must requalify for Initial 1 treatment according to the criteria of the relevant restriction and index of disease severity. A patient must have had at least 1 prior treatment, as listed in the criteria, for a minimum of 6 weeks, and must have a PASI assessment conducted preferably whilst still on treatment, but no later than 1 month following cessation of treatment. The PASI assessment must be no older than 1 month at the time of application.
