0005	Authorities for increased maximum quantities and/or repeats will be granted only for severe disabling pain not responding to non-narcotic analgesics.
0014	Paper wasp venom is not European wasp venom.
0024	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.
0063	The spray should not be inhaled.
0069	The 5 mg strength tablet should be used in malabsorption states only.
0074	Each sachet contains sodium chloride 470 mg, potassium chloride 300 mg, sodium acid citrate 530 mg and glucose 3.56 g.
0099	The dose should be adjusted in accordance with renal function.
0101	Care must be taken to comply with the provisions of State/Territory law when prescribing dexamphetamine.
0102	Care must be taken to comply with the provisions of State/Territory law when prescribing isotretinoin.
0105	Care must be taken to comply with the provisions of State/Territory law when prescribing clomiphene citrate.
0114	Naproxen sodium 550 mg is approximately equivalent to 500 mg of naproxen acid.
0137	Except in cases of hypopituitarism or primary amenorrhoea, the patient should have been adequately treated with clomiphene citrate and/or gonadorelin and failed to have conceived.  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.  Oligomenorrhoea should have been present for at least twelve months or amenorrhoea for at least six months prior to treatment.  Patients with hyperprolactinaemia should have had appropriate surgical or medical treatment prior to treatment.
0138	Prescribing of drugs of addiction by dentists is not permitted in some States/Territories.
0153	Care must be taken to comply with the provisions of State/Territory law when prescribing acitretin.
0161	Studies have shown that successful therapy with this drug is enhanced by patient participation in a support and counselling program.
0172	Helicobacter pylori eradication therapy should be considered.
0177	Application to large areas of skin for longer than four weeks is not recommended.
0178	For patients who have failed to respond to simple moisturising agents.
0179	For patients with chronic renal failure.
0180	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.
0181	The enteric coated preparations are for patients with a significant risk of gastrointestinal bleeding.
0187	For short-term use and palliative care. This drug should not be used as the first line of treatment. Other PBS-listed benzodiazepines should have been adequately tried and found to be ineffective or inappropriate. 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.
0188	Treatment of varices and oedema associated with venous disease and lymphoedema; contraindicated in arterial disease.
0189	Used as an adjunct in the management of leg ulceration and associated eczema and skin conditions.
0190	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of oxazepam below.
0191	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of nitrazepam below.
0193	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.
0195	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.
0197	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.
0198	This dressing should remain in place until saturated or strike through occurs for a maximum of 7 days.
0199	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.
0202	Oestradiol should be used in conjunction with an oral progestogen in women with an intact uterus.
0215	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.
0218	No applications for increased maximum quantities and/or repeats will be authorised.
0227	Suitable for yellow sloughy infected and malodorous wounds.
0245	Treatment must be in accordance with the law of the relevant State or Territory.
0264	The use of meloxicam 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.
0278	No applications for increased repeats will be authorised.
0279	Not for use in the treatment of sclerosing cholangitis or cholelithiasis.
0280	Metronidazole has similar efficacy to vancomycin but may have less selective pressure to vancomycin resistant enterococci and is therefore the preferred treatment.
0283	Not for prophylaxis of DVT or peripheral arterial disease.
0284	This drug is not PBS-subsidised for primary prevention of breast cancer.
0286	Only one application per six months with no more than twice the maximum quantity will be authorised for the tablets.
0290	No applications for increased maximum quantities and/or repeats will be authorised. No more than 1 application per patient will be authorised.
0301	Cyproheptadine hydrochloride is not PBS-subsidised for use in hay fever or atopy.
0304	No applications for repeats will be authorised.
0321	Famciclovir 125 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.
0322	Famciclovir 250 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.
0323	Famciclovir is effective only if commenced within 72 hours of onset of rash. Famciclovir 250 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.
0324	Aciclovir is effective only if commenced within 72 hours of onset of rash. Aciclovir 800 mg is not PBS-subsidised for herpes simplex or chickenpox.
0325	Aciclovir 200 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes.
0326	Valaciclovir is effective only if commenced within 72 hours of onset of rash. Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.
0327	Valaciclovir 500 mg is not PBS-subsidised for chickenpox or herpes simplex infections other than genital herpes.
0337	The risk of serious muscle toxicity is increased if gemfibrozil 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.
0344	Authorities for increased maximum quantities and/or repeats will not be granted except as detailed under the 'Authority required' listing of temazepam below.
0345	The risk of serious muscle toxicity is increased if fenofibrate 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.
0352	The patient should be ideally enrolled in an exercise program and be receiving supplemental vitamins.
0367	Monotherapy for the treatment of osteoporosis does not exclude calcium supplementation.
0372	No applications for increased maximum quantities and/or repeats will be authorised.  Only 1 authority application per 6 months, per patient, will be authorised.
0387	Modafinil is not PBS-subsidised when used in combination with PBS-subsidised dexamphetamine sulfate.
0395	Care must be taken to comply with the provisions of State/Territory law when prescribing methylphenidate hydrochloride.
0435	Carmustine is not PBS-subsidised for use in conjunction with PBS-subsidised temozolomide.
0521	Any queries concerning the arrangements to prescribe modafinil may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). Written applications for authority to prescribe modafinil should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001 Further prescribing information is on the Medicare Australia website at www.medicareaustralia.gov.au.
0529	Famciclovir is effective only if commenced within 72 hours of onset of rash. Famciclovir 500 mg is not PBS-subsidised for chickenpox. Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.
0530	Famciclovir 500 mg is not PBS-subsidised for chickenpox. Famciclovir 500 mg is not PBS-subsidised for herpes zoster, genital herpes or other herpes simplex infections in immunocompetent patients.
0551	For immunisation of adults and children aged greater than or equal to 8 years.
0568	Allogeneic stem cell transplantation is the preferred therapy for eligible patients achieving a complete remission of Philadelphia positive acute lymphoblastic leukaemia.
0571	Dasatinib will only be subsidised for patients with acute lymphoblastic leukaemia who are not receiving concomitant PBS-subsidised imatinib mesylate and who are not appropriate for an allogeneic haemopoietic stem cell transplant.
0580	Only one course of PBS-subsidised bupropion hydrochloride will be authorised per 12 months.  The period between commencing a course of bupropion hydrochloride and varenicline tartrate must be at least 6 months.  A course of treatment with bupropion hydrochloride is 9 weeks.  No increased maximum quantities or repeats will be authorised.  Clinical review is recommended within 2 to 3 weeks of the original prescription being requested.
0583	To be used in conjunction with the scalp cleanser salicylic acid with coal tar solution and pine tar (code 4447C).
0649	Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.
0662	MCT Pro-Cal is not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet.
0663	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
0664	Not to be used in preference to enuresis alarms. Desmopressin nasal spray may be associated with an increased risk of hyponatraemia compared to the oral formulations.
0668	Special Pricing Arrangements apply.
0675	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
0676	Any queries concerning the arrangements to prescribe infliximab 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 infliximab should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
0677	Any queries concerning the arrangements to prescribe etanercept 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 etanercept should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
0680	Atovaquone with proguanil hydrochloride is not PBS-subsidised for the prophylaxis of malaria.
0703	The in-use shelf life of Optive is 6 months from the date of opening.
0706	No applications for increased maximum quantities and/or repeats will be authorised for the 320 mg tablet.
0710	Any queries concerning the arrangements to prescribe sunitinib malate 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. Any queries concerning patients who are enrolled on the Sunitinib Compassionate Program may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). Written applications for authority to prescribe sunitinib malate should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001 Sunitinib malate is not PBS-subsidised for the treatment of patients with resectable malignant gastrointestinal stromal tumours.
0711	Artemether with lumefantrine is not PBS-subsidised for prophylaxis of malaria.
0716	Care should be taken when treating patients with advanced age and significant cognitive impairment with dopamine agonists.
0717	Montelukast sodium 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. Montelukast sodium is not subsidised in a child aged 2 to 5 years for use in combination with other preventer medications. PBS subsidy for montelukast sodium will therefore cease for a child aged 2 to 5 years who requires a preventer medication in addition to montelukast sodium.
0718	Montelukast sodium 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.
0724	Maximum quantity of four tubes (original + 3 repeats) in 12 months.
0726	Any queries concerning the arrangements to prescribe ustekinumab 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 ustekinumab should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
0729	Helicobacter pylori eradication therapy should be considered. No applications for increased repeats will be authorised.
0735	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.
0738	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.
0740	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.
0758	No applications for increased maximum quantities and/or repeats will be approved for extended release pramipexole formulations.
0760	Patients receiving thalidomide under the PBS listing must be registered in the i-access risk management program.
0765	Any queries concerning the arrangements to prescribe tocilizumab may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). Further prescribing information (including Authority Application Forms) is available on the Medicare Australia website at www.medicareaustralia.gov.au. Written applications for authority to prescribe tocilizumab should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
0773	No applications for increased maximum quantities will be authorised.  Palonosetron is not PBS-subsidised for administration with oral 5-HT3 antagonists.
0774	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.
0778	Epoetin lambda should only be administered by the intravenous route.
0781	No applications for increased maximum quantities and/or repeats will be authorised for the 120 mg powder for injection.
0784	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.
0788	Written or telephone authority applications for increased repeats may be approved where consultation with a palliative care specialist or service has occurred.
0789	For first continuing supply, applications for increased repeats may be authorised. Where consultation with a palliative care specialist or service has occurred, applications for increased repeats may be authorised.
0790	Where consultation with a palliative care specialist or service has occurred, applications for increased repeats may be authorised.
0794	Any queries concerning the arrangements to prescribe azacitidine 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 azacitidine should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
0804	TREATMENT OF ADULT PATIENTS WITH SEVERE CHRONIC PLAQUE PSORIASIS The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological agents adalimumab, etanercept, infliximab and ustekinumab, for adult patients with severe chronic plaque psoriasis.  Therefore, where the term 'biological agents' appears in the following NOTES and restrictions, it only refers to adalimumab, etanercept, infliximab and ustekinumab. From 1 March 2010, all patients will be able to commence a 'Biological Treatment Cycle' (Cycle), where they may trial adalimumab, etanercept, infliximab or ustekinumab without having to meet the initial treatment criteria, that is they will not need to experience a disease flare when swapping to an 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. A patient who received PBS-subsidised biological agent treatment for chronic plaque psoriasis prior to 1 March 2010 is considered to be in their first Cycle as of 1 March 2010. Patients are eligible for PBS-subsidised treatment with only 1 biological agent at any 1 time. Within the same Treatment Cycle, a patient cannot trial and 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 a PBS-subsidised biological agent, they must change to an alternate agent if they wish to continue PBS-subsidised biological treatment.  A patient who, prior to 1 March 2010, was authorised to receive PBS-subsidised initial treatment for chronic plaque psoriasis with the same agent twice, is exempt from this condition in respect of applications approved prior to 1 March 2010. Patients must be assessed for response to each course of continuing treatment according to the criteria included in the relevant continuing treatment restriction. 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 agent 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 agent treatment in the most recent Cycle to the date of the first application for initial treatment with a biological agent under the new Treatment Cycle. Patients for whom a break in PBS-subsidised therapy of less than 5 years duration has occurred, and, who have failed therapy fewer than 3 times within a particular Cycle, as defined in the relevant restriction, may commence a further course of treatment within that Cycle. Patients for whom a break in PBS-subsidised therapy of 5 years or more has occurred, and, who have failed therapy fewer than 3 times within a particular Cycle, as defined in the relevant restriction, are eligible to commence a new Cycle. 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 chronic plaque psoriasis after 1 March 2010. 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)  Application for approval for initial treatment. Applications for a course of initial treatment should be made in the following situations: (i)  patients have received no prior PBS-subsidised biological treatment and wish to commence such therapy (Initial 1); or (ii)  patients have received prior PBS-subsidised biological therapy and wish to trial an alternate agent (Initial 2) [further details are under '(4)  Swapping therapy' below]; or (iii)  patients who wish to re-commence treatment following a break in PBS-subsidised therapy with that agent (Initial 2). All applications for initial treatment will be limited to provide for a maximum of 16 weeks of treatment in the case of adalimumab and etanercept, 22 weeks of treatment in the case of infliximab and 28 weeks of treatment in the case of ustekinumab. (2)  Assessment of response to initial treatment. When prescribing initial treatment with a biological agent, a PASI assessment must be conducted after at least 12 weeks of treatment.  This assessment must be submitted to Medicare Australia within 1 month of the completion of this initial treatment course.  Where a response assessment is not undertaken and submitted to Medicare Australia 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 Medicare Australia on 1800 700 270 to discuss. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. (3)  Application for continuing treatment. Following the completion of an initial treatment course of a biological agent to which an adequate response has been demonstrated, patients may qualify to receive up to 24 weeks of continuing treatment with that biological agent.  Patients are eligible to continue to receive continuous treatment with 24 week courses providing they continue to sustain a response. For second and subsequent courses of PBS-subsidised treatment with adalimumab, etanercept, infliximab or ustekinumab it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that an application is posted to Medicare Australia no later than 2 weeks prior to the patient completing their current treatment course. Where a response assessment is not submitted to Medicare Australia within these timeframes, patients will be deemed to have failed to sustain a response to treatment with that biological agent.  In circumstances where it is not possible to submit a response assessment within these timeframes, please call Medicare Australia on 1800 700 270 to discuss. (4)  Swapping therapy. Once an authority for initial treatment with the first PBS-subsidised biological agent is approved, patients may swap to an alternate agent within the same Treatment Cycle without having to requalify with respect to disease severity (i.e. a PASI score of greater than 15), or prior treatment requirements. 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. Patients may trial an alternate biological agent at any time, regardless of whether they are receiving therapy with a biological agent at the time of the application or not.  However, they cannot swap to a particular agent if they have failed to respond to treatment with that particular agent within the same Cycle. Patients who commenced treatment with adalimumab prior to 1 June 2009 or ustekinumab prior to 1 March 2010 access these interchangeability arrangements in the same way as patients who have not. 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 approved, 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 approved authority prescription or remaining repeats for the agent being ceased. (5)  Baseline measurements to determine response. Medicare Australia 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 agent. However, prescribers may provide new baseline measurements any time that an initial treatment authority is submitted within a Treatment Cycle 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 all continuing treatment applications. (6)  Re-commencement of treatment after a 5-year break in PBS-subsidised therapy. Patients who wish to trial a second or subsequent Biological Treatment Cycle, following a break in PBS-subsidised biological therapy of at least 5 years, must requalify for initial treatment according to the criteria of the relevant restriction and index of disease severity.  Patients 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.
0806	Citrulline with carbohydrate is not indicated for the treatment of arginase deficiency and other inborn errors of protein metabolism.
0812	TREATMENT OF COMPLEX REFRACTORY FISTULISING CROHN DISEASE The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab and infliximab for patients with complex refractory fistulising Crohn disease.  Where the term 'tumour necrosis factor (TNF) alfa antagonist' 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 2 TNF-alfa antagonists at any 1 time. From 1 April 2011, under the PBS, all patients will be able to commence a treatment cycle where they may trial each PBS-subsidised TNF-alfa antagonist without having to experience a disease flare when swapping to the alternate agent.  Under these interchangeability arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a TNF-alfa antagonist while they continue to show a response to therapy. A patient who received PBS-subsidised TNF-alfa antagonist treatment prior to 1 April 2011 is considered to be in their first 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 TNF-alfa antagonist 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 TNF-alfa antagonist 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 TNF-alfa antagonist treatment in the most recent cycle to the date of the first application for initial treatment with a TNF-alfa antagonist under the new treatment cycle. A patient who has failed fewer than 3 trials of TNF-alfa antagonists 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 TNF-alfa antagonists 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 TNF-alfa antagonist 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 TNF-alfa antagonist 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) TNF-alfa antagonist 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 TNF-alfa antagonist following a break 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 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 Medicare Australia no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to Medicare Australia within these timeframes, the patient will be deemed to have failed to respond to treatment with that TNF-alfa antagonist. For second and subsequent courses of PBS-subsidised TNF-alfa antagonist treatment, it is recommended that a patient is reviewed in the month prior to completing their current course of treatment and that an application is posted to Medicare Australia 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 a specific TNF-alfa antagonist, 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 TNF-alfa antagonist 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 TNF-alfa antagonist supply. Assessments of response to a course of PBS-subsidised therapy must be submitted to Medicare Australia no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to Medicare Australia within these timeframes, the patient will be deemed to have failed to respond to treatment with that TNF-alfa antagonist. (2) Swapping therapy. Once initial treatment with the first PBS-subsidised TNF-alfa antagonist is approved, a patient may swap if eligible to the alternate TNF-alfa antagonist within the same treatment cycle. A patient may trial the alternate TNF-alfa antagonist at any time, regardless of whether they are receiving therapy (initial or continuing) with a TNF-alfa antagonist at the time of the application.  However, they cannot swap to a particular TNF-alfa antagonist 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 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 the alternate TNF-alfa antagonist should be accompanied by the approved authority prescription or remaining repeats for the TNF-alfa antagonist the patient is ceasing. (3) Baseline measurements to determine response. Medicare Australia will determine whether a response to treatment has been demonstrated based on the baseline measurements submitted with the first authority application for a TNF-alfa antagonist.  However, prescribers may provide new baseline measurements any time that an initial treatment authority application is submitted within a treatment cycle and Medicare Australia 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 trial a second or subsequent treatment cycle following a break in PBS-subsidised TNF-alfa antagonist therapy of at least 5 years, must requalify for initial treatment with respect to the indices of disease severity. (5) Patients 'grandfathered' onto PBS-subsidised treatment with adalimumab or infliximab. A patient who commenced treatment with adalimumab for complex refractory fistulising Crohn disease prior to 4 November 2010 or infliximab prior to 1 March 2010 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 with adalimumab or infliximab will be authorised under this criterion. Following completion of the initial PBS-subsidised course, further applications for treatment with adalimumab or infliximab will be assessed under the continuing treatment restriction. 'Grandfather' arrangements will only apply for the first treatment cycle.  For the second and subsequent cycles, a 'grandfather' patient must requalify for initial 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.
0813	Romiplostim is not PBS-subsidised as an alternative to splenectomy. Any queries concerning the arrangements to prescribe romiplostim may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).  Written applications for authority to prescribe romiplostim should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001 Further prescribing information is on the Medicare Australia website at www.medicareaustralia.gov.au.
0814	Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump.
0815	Patients should have adequate cognitive function to manage administration with a portable continuous infusion pump. A positive clinical response to Duodopa administered via a temporary nasoduodenal tube should be confirmed before a permanent percutaneous endoscopic gastrostomy (PEG) tube is inserted.
0824	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.
0825	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.
0831	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.
0832	Pharmaceutical benefits that have the form methylprednisolone powder for injection 1 g (as sodium succinate) and pharmaceutical benefits that have the form methylprednisolone powder for injection 1 g (as sodium succinate) with diluent are equivalent for the purposes of substitution.
0833	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.
0839	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.
0841	Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals.  Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day.  Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater.  (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al.  N Engl J Med 2002; 347: 472-80.)
0842	Patients will be able to trial either eltrombopag and/or romiplostim within the initial 24 weeks treatment period.  Patients who fail to demonstrate a response to treatment with either eltrombopag and/or romiplostim under the initial restriction will not be eligible to receive further PBS-subsidised treatment with either of these drugs.
0843	Eltrombopag is not PBS-subsidised as an alternative to splenectomy. Any queries concerning the arrangements to prescribe eltrombopag may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). Written applications for authority to prescribe eltrombopag should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001 Further prescribing information is on the Medicare Australia website at www.medicareaustralia.gov.au.
0844	Patients will be able to trial either eltrombopag and/or romiplostim within the initial 24 weeks treatment period.  Patients who fail to demonstrate a response to treatment with either eltrombopag and/or romiplostim under the initial restriction will not be eligible to receive further PBS-subsidised treatment with either of these drugs. No applications for increased repeats will be authorised.
0845	Growth hormone (Somatropin) for adults is currently not subsidised through the Pharmaceutical Benefits Scheme. These guidelines may be obtained from the Department of Health and Ageing's internet site at http://www.health.gov.au/hGH, or from: Growth Hormone Program Access and Systems Branch Department of Health and Ageing GPO Box 9848 CANBERRA ACT 2601 Contact telephone number (02) 6289 7274
0856	Pharmaceutical benefits that have the form fludarabine phosphate powder for I.V. injection 50 mg (after reconstitution) and pharmaceutical benefits that have the form fludarabine phosphate solution for I.V. injection 50 mg are equivalent for the purposes of substitution.
0860	Pharmaceutical benefits that have the form paroxetine tablet 20 mg (as hydrochloride) and pharmaceutical benefits that have the form paroxetine tablet 20 mg (as mesilate) are equivalent for the purposes of substitution.
0870	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.
0871	Pharmaceutical benefits that have the form ondansetron tablet (orally disintegrating) 4 mg and pharmaceutical benefits that have the form ondansetron wafer 4 mg are equivalent for the purposes of substitution.
0874	Pharmaceutical benefits that have the form ondansetron tablet (orally disintegrating) 8 mg and pharmaceutical benefits that have the form ondansetron wafer 8 mg are equivalent for the purposes of substitution.
0879	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.
0880	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.
0887	Indacaterol is not PBS-subsidised for the treatment of asthma.
0894	Bandage can be left in situ for up to 7 days as per manufacturer's instructions.
0896	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 5 mL, 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.
0897	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 1 g (as hydrochloride) in 25 mL, 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.
0898	Pharmaceutical benefits that have the forms gemcitabine powder for I.V. infusion 2 g (as hydrochloride) (after reconstitution), gemcitabine solution concentrate for I.V. infusion 2 g (as hydrochloride) in 50 mL and gemcitabine solution for injection 2 g (as hydrochloride) in 52.6 mL are equivalent for the purposes of substitution.
0899	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.
0900	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.
0901	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.
0902	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.
0903	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.
0904	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.
0905	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.
0906	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.
0908	TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE RHEUMATOID ARTHRITIS The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological disease modifying anti-rheumatic 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) and the T-cell co-stimulation modulator (abatacept). Patients are eligible for PBS-subsidised treatment with only 1 of the above biological disease modifying anti-rheumatic drugs at any 1 time. PBS-subsidised abatacept, golimumab, infliximab and rituximab must be used in combination with methotrexate at a dose of at least 7.5 mg weekly.  Where a patient cannot tolerate 7.5 mg of methotrexate weekly, they are eligible to receive PBS-subsidised adalimumab, certolizumab pegol, etanercept and tocilizumab. 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 Medicare Australia 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 and tocilizumab, 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 Medicare Australia 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 Medicare Australia within 4 weeks. Where a response assessment is not submitted to Medicare Australia 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 an application is submitted to Medicare Australia 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 pre-filled syringes, 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 Medicare Australia 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 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 Medicare Australia no later than 4 weeks from the date that course was ceased. 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 Medicare Australia 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 (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: 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. 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 approved, within the timeframes specified in the relevant restriction. PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised biological agent 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 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 approved authority prescription or remaining repeats for the bDMARD the patient is ceasing.
0909	(3) Baseline measurements to determine response. Medicare Australia 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 Medicare Australia 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 provided 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 provided 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.
0910	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 mesylate 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 treatment  From 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 treatment Third-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 treatment All 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.
0911	Any queries concerning the arrangements to prescribe dasatinib 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. Applications for authority to prescribe dasatinib should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
0912	Any queries concerning the arrangements to prescribe nilotinib 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. Applications for authority to prescribe nilotinib should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
0913	Any queries concerning the arrangements to prescribe imatinib mesylate 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 imatinib mesylate should be forwarded to: Medicare Australia Prior Written Approval of Specialised Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001 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.
0914	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 mesylate, 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 treatment - imatinib mesylate, dasatinib and nilotinib From 1 April 2012, under the PBS, a patient will be able to be prescribed any of imatinib mesylate, 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 of response. 2. Continuing treatment with imatinib mesylate - first-line 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 with imatinib mesylate may be made on the telephone by contacting Medicare Australia on 1800 700 720 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday). Patients must maintain a major cytogenetic response or have a peripheral blood BCR-ABL of less than 1% to receive continuing therapy. 3. Continuing treatment with dasatinib or nilotinib - first-line All 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. 4. For imatinib mesylate, dasatinib and nilotinib 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 of response, switching may only occur through application for prescription of second-line agents. Where a patient has previously received PBS-subsidised treatment with imatinib mesylate, 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. 5. Authority approval requirements. Response criteria to initial treatment with imatinib mesylate, dasatinib or nilotinib: For the purposes of assessing response to PBS-subsidised treatment with imatinib mesylate, 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 mesylate, 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). 6. 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. 7. 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.
0918	TREATMENT OF PATIENTS WITH SEVERE ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS The 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: - continue to receive long-term treatment with PBS-subsidised tocilizumab while they continue to show a response to therapy, and - 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 re-commence 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  (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 Medicare Australia no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to Medicare Australia 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 Medicare Australia 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 Medicare Australia no later than 4 weeks from the date that course was ceased. Where a response assessment is not submitted to Medicare Australia 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. Medicare Australia 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.  Medicare Australia 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 Medicare Australia to assess response to the second course. (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 tocilizumab therapy of at least 12 months, must requalify for treatment under the Initial 1 treatment restriction. (5) Patients 'grandfathered' onto PBS-subsidised treatment with tocilizumab. A patient who commenced treatment with tocilizumab for severe active systemic juvenile idiopathic arthritis prior to 1 November 2011 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 with tocilizumab will be authorised under this criterion. Following completion of the initial PBS-subsidised course, further applications for treatment with tocilizumab will be assessed under the continuing treatment restriction. 'Grandfather' arrangements will only apply for the first treatment cycle. For the second and subsequent cycles, a 'grandfather' patient must qualify for initial treatment under the criteria that apply to a new patient.  See 'Re-commencement of treatment after a 12 month break in PBS-subsidised therapy' above for further details. (6) Withdrawal of treatment after sustained remission. Withdrawal of treatment with tocilizumab should be considered in a patient who has achieved and sustained complete remission of disease for 12 months.  A demonstration of response to the current treatment should be submitted to Medicare Australia at the time treatment is ceased.
0921	For item codes 1003T and 1555W, pharmaceutical benefits that have the form tablet 200 mg are equivalent for the purposes of substitution.
0922	Aciclovir 200 mg is not PBS-subsidised for chickenpox, herpes zoster or herpes simplex infections other than genital herpes. No applications for increased maximum quantities and/or repeats will be authorised.
0923	For item codes 2600W and 1557Y, pharmaceutical benefits that have the form tablet 100 mg are equivalent for the purposes of substitution.
0924	For item codes 1443Y and 1559C, pharmaceutical benefits that have the form tablet 2.5 mg (base) are equivalent for the purposes of substitution.
0926	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.
0928	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.
0929	For item codes 2419H and 1706T, pharmaceutical benefits that have the form tablet 200 mg are equivalent for the purposes of substitution.
0932	For item codes 5040G and 1724R, pharmaceutical benefits that have the form tablet 200 mg are equivalent for the purposes of substitution.
0933	For item codes 1085D and 1758M, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
0934	For item codes 1086E and 1759N, pharmaceutical benefits that have the form powder for injection 2 g are equivalent for the purposes of substitution.
0935	For item codes 5048Q and 1768C, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
0936	For item codes 5049R and 1769D, pharmaceutical benefits that have the form powder for injection 2 g are equivalent for the purposes of substitution.
0937	For item codes 1784X and 1788D, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
0938	For item codes 1257E and 1797N, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
0939	For item codes 5478H and 1799Q, pharmaceutical benefits that have the form powder for injection 1 g are equivalent for the purposes of substitution.
0940	For item codes 2414C and 1810G, pharmaceutical benefits that have the form tablet 20 mg are equivalent for the purposes of substitution.
0944	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.
0948	For item codes 6208R and 1837Q, pharmaceutical benefits that have the form capsule 250 mg are equivalent for the purposes of substitution.
0949	For item codes 9501C and 1839T, pharmaceutical benefits that have the form capsule 250 mg are equivalent for the purposes of substitution.
0950	For item codes 2642C and 1841X, pharmaceutical benefits that have the form tablet 600 mg (sustained release) are equivalent for the purposes of substitution.
0951	For item codes 8787L and 1842Y, pharmaceutical benefits that have the form tablet 0.5 mg are equivalent for the purposes of substitution.
0952	For item codes 8869T and 1846E, pharmaceutical benefits that have the form tablet 0.5 mg are equivalent for the purposes of substitution.
0953	For item codes 2110C and 1880Y, pharmaceutical benefits that have the form tablet 20 mg (base) 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 ServicesPrior Written Approval of Complex Drugs Reply Paid 9826 GPO Box 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.
7868	Written or telephone authority applications for increased repeats may be approved where consultation with a palliative care specialist or service has occurred. 
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 ServicesPrior Written Approval of Complex Drugs Reply Paid 9826 GPO Box 9826 HOBART TAS 7001
7938	Authority applications for continuing treatment may be faxed to the Department of Human Services on 1300 154 190 (hours of operation 8.a.m. to 5 p.m. EST Monday to Friday). The Department will then contact the prescriber by telephone.
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.
7991	Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride, strontium ranelate and zoledronic acid.
8009	Patients who have progressive disease on sunitinib are not eligible to receive PBS-subsidised pazopanib.
8016	Patients who have developed progressive disease on pazopanib are not eligible to receive PBS-subsidised sunitinib.
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 ServicesPrior Written Approval of Complex Drugs Reply Paid 9826 GPO Box 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.
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.
9161	Dornase alfa is not PBS-subsidised for use in combination with PBS-subsidised mannitol.
9162	It is highly desirable that all patients be included in the national cystic fibrosis patient database.
9196	Mannitol is not PBS-subsidised for use in combination with PBS-subsidised dornase alfa.
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-narcotic analgesics where the total duration of narcotic 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-narcotic 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 narcotic 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-narcotic 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. 
9872	This drug is not PBS-subsidised for use in combination with metformin and a sulfonylurea (triple oral therapy), as monotherapy 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.
10079	Pharmaceutical benefits that have the form disodium pamidronate powder for I.V. infusion 30 mg (after reconstitution) and pharmaceutical benefits that have the form disodium pamidronate concentrated injection 30 mg are equivalent for the purposes of substitution.
10084	Pharmaceutical benefits that have the form disodium pamidronate powder for I.V. infusion 90 mg (after reconstitution) and pharmaceutical benefits that have the form disodium pamidronate concentrated injection 90 mg 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.
10353	Panitumumab is not PBS-subsidised for use in combination with oxaliplatin-based therapies.
10370	In first-line usage, effectiveness and tolerance may be improved when irinotecan is combined with an infusional 5-fluorouracil regimen. 
10374	Pharmaceutical benefits that have the form oxaliplatin powder for I.V. infusion 50 mg (after reconstitution) and pharmaceutical benefits that have the form oxaliplatin solution concentrate for I.V. infusion 50 mg are equivalent for the purposes of substitution. 
10375	Pharmaceutical benefits that have the form oxaliplatin powder for I.V. infusion 100 mg (after reconstitution) and pharmaceutical benefits that have the form oxaliplatin solution concentrate for I.V. infusion 100 mg are equivalent for the purposes of substitution. 
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.
10492	Saxagliptin 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.
10494	Vildagliptin 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.
10496	Linagliptin 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.
10498	Sitagliptin 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.
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 ServicesPrior Written Approval of Complex DrugsReply Paid 9826GPO Box 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).
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.
10878	Pharmaceutical benefits that have the form metronidazole 500 mg/100 mL (0.5%) injection, 10 x 100 mL bags and pharmaceutical benefits that have the form metronidazole 500 mg/100 mL (0.5%) injection, 5 x 100 mL bags are equivalent for the purposes of substitution.
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 ServicesPrior Written Approval of Complex DrugsReply Paid 9826GPO Box 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.
11125	Pharmaceutical benefits that have the form epoprostenol sodium powder for I.V. infusion 1.5 mg (base) infusion administration set and pharmaceutical benefits that have the form epoprostenol 1.5 mg injection vial are equivalent for the purposes of substitution.
11126	Pharmaceutical benefits that have the form epoprostenol sodium powder for I.V. infusion 500 micrograms (base) infusion administration set and pharmaceutical benefits that have the form epoprostenol 500 microgram injection vial are equivalent for the purposes of substitution.
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
11179	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 and infliximab for adult patients with active ankylosing spondylitis. Where the term 'bDMARD' appears in notes and restrictions, it refers to adalimumab, certolizumab pegol, etanercept, golimumab and infliximab only. A patient is eligible for PBS-subsidised treatment with only 1 of the 5 bDMARDs at any 1 time.From 1 March 2007, under the PBS, all patients will be able to commence a treatment cycle where they may trial PBS-subsidised bDMARDs without having to experience a disease flare when swapping to the alternate agent. 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. A patient who received PBS-subsidised bDMARD treatment prior to 1 March 2007 is considered to be in their first cycle as of 1 March 2007. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised bDMARD more than once. A patient who, prior to 1 March 2007, was authorised to receive PBS-subsidised initial treatment for ankylosing spondylitis with the same agent twice, is exempt from this condition in respect of applications approved prior to 1 March 2007. 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 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 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 2). 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 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. (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 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 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 provided 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 provided 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. 
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
11214	Authority approval for sufficient therapy to complete a maximum of 18 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 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.
11428	The treatment must not be used in combination with an ICS/LABA, or LAMA or LABA monotherapy. 
11429	A LAMA includes tiotropium, glycopyrronium, aclidinium or umeclidinium.
11430	A LABA includes indacaterol, salmeterol, eformoterol or vilanterol.
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.
11480	Pharmaceutical benefits that have the forms docetaxel solution concentrate for I.V. infusion 20 mg in 1 mL, docetaxel solution concentrate for I.V. infusion 20 mg in 2 mL and docetaxel powder for I.V. infusion 20 mg (after reconstitution) are equivalent for the purposes of substitution.Pharmaceutical benefits that have the forms docetaxel solution concentrate for I.V. infusion 80 mg in 4 mL, docetaxel solution concentrate for I.V. infusion 80 mg in 8 mL and docetaxel powder for I.V. infusion 80 mg (after reconstitution) are equivalent for the purposes of substitution.
11491	Patient must not be on a concomitant single agent long-acting beta-2 agonist.
11513	This drug is not PBS subsidised for use in combination with metformin and a sulfonylurea (triple oral therapy), as monotherapy or in combination with an insulin, a thiazolidinedione (glitazone), a dipeptidyl peptidase 4 inhibitor (gliptin) or a glucagon-like peptide-1. 
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.
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.
11601	This drug is not PBS-subsidised for use as monotherapy.
11667	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). Written applications for authority approval for sufficient therapy to complete a maximum of 3 initial doses or 2 repeats should be forwarded to: Department of Human ServicesComplex Drugs Reply Paid 9826 HOBART TAS 7001
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
11699	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), thechimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-6 inhibitor (tocilizumab) and the T-cell co-stimulation modulator (abatacept).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) [furtherdetails 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 withthat 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 and tocilizumab, 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 Serviceswithin 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 themonth prior to completing their current course of treatment and 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.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 pre-filled syringes, with a maximum quantity of 4 and up to 3 repeats, must be submitted with the initialapplication.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 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.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.
11716	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) and the T-cell co-stimulation modulator (abatacept).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 and tocilizumab, 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 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 pre-filled syringes, 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 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.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 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 (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: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.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 approved, within the timeframes specified in the relevant restriction.PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised biological agent 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 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 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, 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 provided 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 provided 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.
11734	Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. This will assist DHS in the consideration of the patient s eligibility for further PBS subsidised treatment 
11735	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) 
11736	Applications for treatment with eculizumab where the dose and dosing frequency exceeds that specified in the approved PI will not be approved. 
11737	WARNING: Eculizumab increases the risk of meningococcal infections (septicaemia and/or meningitis)> Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of eculizumab; revaccinate according to current medical guidelines for vaccine use> Patients less than 2 years of age and those who are treated with eculizumab less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary. 
11742	No increase in the maximum quantity or number of units may be authorised.No increase in the maximum number of repeats may be authorised.Applications for treatment with this drug where the dosing frequency exceeds 40 mg per fortnight will not be approved.Special Pricing Arrangements apply 
11757	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). 
11770	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).
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.
11853	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) and the T-cell co-stimulation modulator (abatacept).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 and tocilizumab, 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 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 pre-filled syringes, 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 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.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 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 (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: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.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 approved, within the timeframes specified in the relevant restriction.PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised biological agent 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 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 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, 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 provided 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 provided 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.
11866	(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 (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: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.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 approved, within the timeframes specified in the relevant restriction.PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised biological agent 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 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 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, 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 provided 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 provided 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 ceasingDMARD therapy.
11896	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 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.(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) and oral corticosteroid dose, 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 (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.
11908	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), thechimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-6 inhibitor (tocilizumab) and the T-cell co-stimulation modulator (abatacept).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, andonce 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 and tocilizumab, 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 Serviceswithin 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 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 pre-filled syringes, 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 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.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 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 (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: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.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 approved, within the timeframes specified in the relevant restriction.PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised biological agent 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 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 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, 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 provided 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 provided 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.
11918	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).Written application for authority approval for sufficient therapy to complete a maximum of 22 weeks of treatment should be forwarded to: Department of Human ServicesPrior Written Approval of Complex DrugsReply Paid 9826HOBART TAS 7001
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.
12774	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 and infliximab 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 and infliximab 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 restriction 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 approval for PBS-subsidised treatment was granted 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.Patients for whom a break in PBS-subsidised therapy of 5 years or more has occurred, and, who have failed therapy fewer than 3 times within a particular treatment Cycle, as defined in the relevant restriction, are eligible to commence a new Cycle.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 2).All applications for initial treatment for non-grandfather patients will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, etanercept and golimumab, 18 to 20 weeks of therapy for certolizumab pegol (depending upon the dosing regimen), and 22 weeks of therapy for infliximab. 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.Grandfather patients - certolizumab pegol only.For patients who commenced treatment with certolizumab pegol for psoriatic arthritis prior to 1 April 2015, applications for initial PBS-subsidised treatment as continuing therapy may be made under the relevant initial treatment restriction (Initial 3). These patients access the PBS interchangeability arrangements in the same way as new patients who have not been treated with any biological agent prior to PBS listing of that agent.Applications for initial PBS-subsidised treatment for grandfather patients will provide for a maximum of 24 weeks of treatment for all agents. Approval will be based on the criteria included in the relevant restriction. (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 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.(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 approved, 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 approved authority prescription or remaining repeats for the biological agent the patient is ceasing.(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 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 provided 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 provided 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 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.
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.
12858	This drug is not PBS subsidised for use as monotherapy or in combination with a thiazolidinedione (glitazone), a dipeptidyl peptidase 4 inhibitor (gliptin) or a glucagon-like peptide-1. 
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.
12963	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). Written application for authority approval for sufficient therapy to complete a maximum of 22 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
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.
13147	Anti-resorptive agents in osteoporosis include alendronate sodium, risedronate sodium, denosumab, raloxifene hydrochloride, strontium ranelate and zoledronic acid.
13287	No applications for repeats will be authorised.
13290	No applications for increased repeats will be authorised. 
13404	The maximum quantities for salcatonin shown represent the number of individual ampoules and NOT multiples of the manufacturer's packs. The pack size for both strengths is five ampoules.
13555	This drug is not PBS-subsidised for conditions other than CAPS.
13615	No applications for increased maximum quantities will be authorised.
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-narcotic analgesics where the total duration of narcotic 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-narcotic 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 narcotic 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-narcotic analgesics where a PBS authority prescription for treatment beyond 12 months has previously been issued for this patient.
13892	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). Written application for authority approval for sufficient therapy to complete a maximum of 28 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
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.
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.
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.)
14063	Authority approvals will be limited to a maximum quantity of 2 auto-injectors (Anapen or EpiPen) at any one time.
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.
14292	This drug is not PBS-subsidised for use in combination with another anti-EGFR antibody or in combination with an anti-VEGF antibody.
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.
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.
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). 
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.
14807	 For prescribing in accordance with Optometry Board of Australia guidelines.
14966	TREATMENT OF PAEDIATRIC PATIENTS WITH REFRACTORY CROHN DISEASEThe 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 'tumour necrosis factor (TNF) alfa antagonist' 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 2 TNF-alfa antagonists 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 TNF-alfa antagonist 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 TNF-alfa antagonist 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 TNF-alfa antagonist while they continue to show a response to therapy. A patient who received PBS-subsidised TNF-alfa antagonist treatment prior to 1 August 2015 is considered to be in their first cycle as of 1 August 2015. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised TNF-alfa antagonist 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 TNF-alfa antagonist 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 TNF-alfa antagonist treatment in the most recent cycle to the date of the first application for initial treatment with a TNF-alfa antagonist under the new treatment cycle.A patient who has failed fewer than 3 trials of TNF-alfa antagonists 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 TNF-alfa antagonists 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 TNF-alfa antagonist 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 TNF-alfa antagonist 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) TNF-alfa antagonist 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 TNF-alfa antagonist following a break 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 for adalimumab and 14 weeks of therapy for infliximab.From 1 August 2015, a patient must be assessed for response to a 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 theDepartment 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 TNF-alfa antagonist.For second and subsequent courses of PBS-subsidised TNF-alfa antagonist treatment, it is recommended that a patient is reviewed in the month 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.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 TNF-alfa antagonist, 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 TNF-alfa antagonist 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 TNF-alfa antagonist supply.Assessments of response to a course of PBS-subsidised therapy must be submitted 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 TNF-alfa antagonist.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised TNF-alfa antagonist is approved, a patient with severe disease may swap if eligible to the alternate TNF-alfa antagonist 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 particular TNF-alfa antagonist 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 swapping 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 the alternate TNF-alfa antagonist (where eligible in terms of disease severity) should be accompanied by the approved authority prescription or remaining repeats for the TNF-alfa antagonist 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 PCDAI submitted with the first authority application for a TNF-alfa antagonist. 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 provided for all subsequent continuing treatment applications.(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 TNF-alfa antagonist 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.(5) Patients 'grandfathered' onto PBS-subsidised treatment with adalimumab.A patient who commenced treatment with adalimumab for severe refractory 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 with adalimumab will be authorised under this criterion.Following completion of the initial PBS-subsidised course, further applications for treatment with adalimumab will be assessed under the continuing treatment restriction.'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 continuing patient. 
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
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.
15440	This product contains higher vitamin A levels than other PBS-listed glycomacropeptide products.
15938	Prescribers must provide the patient's unique identifier (in form XALK XXX, where XXX is a numerical value) when requesting PBS Authority approval. The patient's unique identifier is received upon registering the patient with the sponsor's crizotinib (Xalkori) Managed Entry Scheme website.Please visit www.xalkorimes.com.au
15939	Prescribers must provide the patient's unique identifier (in form XALK XXX, where XXX is a numerical value) when requesting PBS Authority approval. The patient's unique identifier was received upon registering the patient with the sponsor's crizotinib (Xalkori) Managed Entry Scheme website at the time of initiation.
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.
16749	MANAGED ENTRY SCHEMEThis medicine has been listed on the PBS via a Managed Entry Scheme (MES). This MES provides a mechanism to address the uncertainty over the size of the additional clinical benefit of this medicine while providing early access to those patients for whom there is a high clinical need. Information about the benefits of this medicine in clinical practice will be collected, analysed and presented to the Pharmaceutical Benefits Advisory Committee (PBAC) for consideration in the near future. Prescribers and patients must be aware that if a drug listed via a MES does not prove as beneficial in clinical practice as appeared in the clinical data presented to the PBAC, it may subsequently have its restriction modified, or may be removed from the PBS by the Commonwealth or at the request of the sponsor. The relevant information for crizotinib is being collected about selected patients from their prescribing doctor. Patients are being selected on the grounds that they are crizotinib-naive when initiating PBS supply. Selection will stop when there are enough patients providing the relevant information.Details of these arrangements are included in an information sheet that must be provided by the prescribing doctor to each selected patient receiving PBS-subsidy for this medicine.For more information on Managed Entry Schemes, please visit http://www.pbs.gov.au/info/publication/factsheets/shared/framework-for-introduction-of-managed-entry-scheme-for-PBAC-submissions.For more information on the PBAC's consideration of this medicine and its MES, please visit http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2014-11/crizotinib-psd-11-2014
16834	MANAGED ENTRY SCHEMEThis medicine has been listed on the PBS via a Managed Entry Scheme (MES). This MES provides a mechanism to address the uncertainty over the size of the additional clinical benefit of this medicine while providing early access to those patients for whom there is a high clinical need. Information about the benefits of this medicine in clinical practice will be collected, analysed and presented to the Pharmaceutical Benefits Advisory Committee (PBAC) for consideration in the near future. Prescribers and patients must be aware that if a drug listed via a MES does not prove as beneficial in clinical practice as appeared in the clinical data presented to the PBAC, it may subsequently have its restriction modified, or may be removed from the PBS by the Commonwealth or at the request of the sponsor. In the case of trametinib, the relevant information is being collected from an ongoing clinical trial outside the PBS. Details of these arrangements are included in an information sheet that must be provided by the prescribing doctor to each patient receiving PBS-subsidy for this medicine.For more information on Managed Entry Schemes, please visit http://www.pbs.gov.au/info/publication/factsheets/shared/framework-for-introduction-of-managed-entry-scheme-for-PBAC-submissions.For more information on the PBAC's consideration of this medicine and its MES, please visit http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2014-11/trametinib-psd-11-2014
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
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
17017	TREATMENT OF ADULT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of infliximab and vedolizumab for adult patients with ulcerative colitis. Patients are eligible for PBS-subsidised treatment with either infliximab or vedolizumab at any one time. From 1 August 2015, under the PBS, all patients will be able to commence a treatment cycle where they may trial each PBS-subsidised infliximab or vedolizumab 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 infliximab or vedolizumab while they continue to show a response to therapy. A patient who received PBS-subsidised infliximab or vedolizumab treatment prior to 1 August 2015 is considered to be in their first cycle as of 1 August 2015. Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised infliximab or vedolizumab 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 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 infliximab or vedolizumab treatment in the most recent cycle to the date of the first application for initial treatment with infliximab or vedolizumab under the new treatment cycle.A patient who has failed fewer than 3 trials of either infliximab or vedolizumab 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 either 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 infliximab or vedolizumab 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 treatment with infliximab or vedolizumab in this treatment cycle and wishes to commence such therapy (Initial 1); or (ii) a patient has received prior PBS-subsidised (initial or continuing) infliximab or vedolizumab 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 infliximab or vedolizumab following a break in PBS-subsidised therapy with the same agent (Initial 2). Initial treatment authorisations will be limited to provide for a maximum of 14 weeks of therapy. From 1 August 2015, a patient must be assessed for response to any course of initial PBS-subsidised treatment up to 12 weeks after the first dose (6 weeks following the third dose), 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 drug. For second and subsequent courses of PBS-subsidised infliximab or vedolizumab treatment, it is recommended that a patient is reviewed in the month 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 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 to ensure uninterrupted supply of treatment. 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 drug. (2) Swapping therapy.Once initial treatment with the first PBS-subsidised treatment is approved, a patient may swap if eligible to the alternate 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 the alternate treatment at any time, regardless of whether they are receiving therapy (initial or continuing) with 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 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 approved, within the timeframes specified in the relevant restriction. To avoid confusion, an application for a patient who wishes to swap to the alternate infliximab or vedolizumab therapy should be accompanied by the approved authority prescription or remaining repeats for the therapy 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 Mayo clinic score or partial Mayo clinic score submitted with the first authority application for infliximab or vedolizumab. 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 provided for all subsequent continuing treatment applications. (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 infliximab or vedolizumab therapy of at least 5 years, must requalify for initial treatment with respect to the scores of disease severity. Patients 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, 6-mercaptopurine or tapered course of oral steroids (unless intolerance develops necessitating permanent treatment withdrawal) for a minimum of 3 consecutive months immediately prior to the time the Mayo score or PUCAI score is measured.(5) Patients 'grandfathered' onto PBS-subsidised treatment with vedolizumab or infliximab. A patient who commenced treatment with vedolizumab for moderate to severe ulcerative colitis prior to 1 August 2015 or infliximab prior to 1 December 2014 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 initial 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. 
17033	Written applications for authority approval for sufficient therapy to complete the balance of supply should be forwarded to:Department of Human ServicesPrior Written Approval of Complex DrugsReply Paid 9826 HOBART TAS 7001
17039	TREATMENT OF ADULT PATIENTS WITH SEVERE CROHN DISEASEThe following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological disease modifying drugs (bDMDs) for adult patients with severe Crohn disease. Where the term bDMDs 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). Patients are eligible for PBS-subsidised treatment with only 1 of the above PBS-subsidised biological disease modifying drugs at any one time.From 1 August 2015, under the PBS, all patients will be able to commence a treatment cycle where they may trial PBS-subsidised TNF-alfa antagonist or vedolizumab without having to experience a disease flare when swapping to the alternate agent. Under these arrangements, within a single treatment cycle, a patient may continue to receive long-term treatment with a TNF-alfa antagonist or vedolizumab while they continue to show a response to therapy.A patient who received PBS-subsidised TNF-alfa antagonist or vedolizumab treatment prior to 1 August 2015 is considered to be in their first cycle as of 1 August 2015.Within the same treatment cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised TNF-alfa antagonist or vedolizumab 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 bDMD 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 TNF-alfa antagonist or vedolizumab treatment in the most recent cycle to the date of the first application for initial treatment with a TNF-alfa antagonist or vedolizumab under the new treatment cycle. A patient who has failed fewer than 3 trials of bDMD 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 bDMD 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 TNF-alfa antagonist or vedolizumab 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 therapy with TNF-alfa antagonist or vedolizumab in this treatment cycle and wishes to commence such therapy (new patients); or(ii) a patient has received prior PBS-subsidised (initial or continuing) TNF-alfa antagonist therapy or vedolizumab and wishes to trial an alternate agent (recommencement) [further details are under 'Swapping therapy' below]; or(iii) a patient wishes to re-commence treatment with a specific TNF-alfa antagonist or vedolizumab following a break in PBS-subsidised therapy with that agent (change or re-commencement).Initial treatment authorisations will be limited to provide for a maximum of 16 weeks of therapy for adalimumab, 14 weeks of therapy for infliximab and 14 weeks of therapy for vedolizumab.From 1 August 2015, 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 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 bDMD therapy.For second and subsequent courses of PBS-subsidised TNF-alfa antagonist or vedolizumab treatment, it is recommended that a patient is reviewed in the month 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.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 TNF-alfa antagonist 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 to ensure uninterrupted supply of treatment.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 drug.(2) Swapping therapy.Once initial treatment with the first PBS-subsidised bDMD therapy is approved, a patient may swap if eligible to the alternate TNF-alfa antagonist or vedolizumab 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 the alternate bDMD therapy at any time, regardless of whether they are receiving therapy (initial or continuing) with a TNF-alfa antagonist or vedolizumab at the time of the application. However, they cannot swap to a particular bDMD therapy 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 approved, within the timeframes specified in the relevant restriction.To avoid confusion, an application for a patient who wishes to swap to the alternate TNF-alfa antagonist or vedolizumab (where eligible in terms of disease severity) should be accompanied by the approved authority prescription or remaining repeats for the therapy 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 CDAI or evidence of intestinal inflammation submitted with the first authority application for a TNF-alfa antagonist or vedolizumab. 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 provided for all subsequent continuing treatment applications.(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 bDMD 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.
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 posted 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. 
17187	The patient or guardian (required if patient is aged 6 to 17 years) must have signed a patient acknowledgement indicating that he or she understands and acknowledges that the PBS-subsidised treatment will cease if he or she does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment.
