0005	Authorities for increased maximum quantities and/or repeats will be granted only for severe disabling pain not responding to non-narcotic analgesics.
0013	One injection of hydroxocobalamin 1 mg every three months provides appropriate maintenance therapy in vitamin B12 deficiencies.
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.
0028	The recommended maximum dose is 600 mg per day.
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.
0122	This dressing should remain in place on wounds with odour 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.
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.
0228	These prices are based on special supply arrangements - see Pharmaceutical Benefits Pricing Authority relativity sheet for full details.
0232	It is highly desirable that all patients be included in the national cystic fibrosis patient data-base.
0235	The units used to express the potency of botulinum toxin preparations currently available for PBS subsidy are not equivalent.
0245	Treatment must be in accordance with the law of the relevant State or Territory.
0250	For use with Amino Acid Formula without Phenylalanine.
0255	Not to be used in preference to enuresis alarms.
0257	Medical practitioners should request the appropriate quantity of vials at the time of the authority application, according to the weight of the patient, to achieve a dose of 24 micrograms per kg per hour over a maximum of 96 hours.
0263	The use of celecoxib 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.
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.
0267	Monogen is not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet.
0268	Caprilon is not indicated for the treatment of intractable childhood epilepsy or cerebrospinal fluid glucose transporter defect requiring a ketogenic diet, long chain fatty acid oxidation disorders or hyperlipoproteinaemia type 1.
0270	Montelukast sodium is not PBS-subsidised for use in children with moderate or severe asthma. It is not intended as an alternative for children who require a corticosteroid as a preventer medication. Montelukast sodium is not PBS-subsidised for use in combination with other preventer medications. PBS subsidy for montelukast sodium will therefore cease for patients who require a preventer medication in addition to montelukast sodium.
0271	Any queries concerning the arrangements to prescribe infliximab may be directed to the Veterans' Affairs Pharmaceutical Approvals Centre (VAPAC) on 1800 552 580.   Written applications for authority to prescribe infliximab should be forwarded to:   Reply Paid 372  Veterans' Affairs Pharmaceutical Approvals Centre (VAPAC)  GPO Box 9998  BRISBANE QLD 4001
0276	Helicobacter pylori eradication therapy should be considered prior to commencing initial treatment of peptic ulcer with this drug.
0277	Authorities for increased maximum quantities, up to a maximum of 20, may be authorised.
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.
0281	Not for the treatment of Crohn's disease.
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.
0289	Any queries concerning the arrangements to prescribe imatinib mesylate may be directed to the Health Insurance Commission on 1800 242 679.   Written applications for authority to prescribe imatinib mesylate should be forwarded to:   Health Insurance Commission  Prior Written Approval of Specialised Drugs  Reply Paid 76335  GPO Box 9826  MELBOURNE VIC 3001
0290	No applications for increased maximum quantities and/or repeats will be authorised. No more than 1 application per patient will be authorised.
0293	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.)
0294	Authorities for increased maximum quantities, up to a maximum of 2, may be authorised for children aged less than 17 years where 2 auto-injectors are necessary to ensure 1 is on hand at all times. No increased maximum quantities will be authorised for patients aged 17 years or older.   No repeats will be issued.
0300	This price is based on special supply arrangements - see Pharmaceutical Benefits Pricing Authority relativity sheet for full details.
0301	Cyproheptadine hydrochloride is not PBS-subsidised for use in hay fever or atopy.
0304	No applications for repeats will be authorised.
0314	Care should be taken when changing <I>Allevyn Adhesive dressings to avoid skin tears.
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.
0338	No applications for increased maximum quantities will be authorised.
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.
0353	No applications for increased maximum quantities will be authorised. Up to 2 repeats may be authorised for item 6440Y or 6441B.
0354	Up to 5 repeats may be authorised for item 6444E or 6445F.
0355	Up to 2 repeats may be authorised for item 6446G or 6447H.
0363	Imatinib mesylate is not PBS-subsidised for the treatment of patients with resectable malignant gastrointestinal stromal tumours.
0364	Patients 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.)
0367	Monotherapy for the treatment of osteoporosis does not exclude calcium supplementation.
0368	In first-line usage, effectiveness and tolerance may be improved when irinotecan is combined with an infusional 5-fluorouracil regimen.
0369	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; and  (d) facilities for safe liver biopsy.
0371	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.
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.
0373	Each authority approval will be limited to no more than 240 tablets per month for no more than 6 months.
0374	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 below.
0377	Aprepitant is not PBS-subsidised for nausea and vomiting associated with radiotherapy being used to treat malignancy.
0378	No applications for increased maximum quantities and/or repeats will be authorised.  Applications for treatment with adalimumab where the dosing frequency exceeds 40 mg per fortnight will not be approved.
0387	Modafinil is not PBS-subsidised when used in combination with PBS-subsidised dexamphetamine sulfate.
0392	Applications for doses above 150 mg per day will not be authorised. No applications for increased repeats will be authorised.
0395	Care must be taken to comply with the provisions of State/Territory law when prescribing methylphenidate hydrochloride.
0396	Bivalirudin trifluoroacetate has not been evaluated in patients undergoing emergency percutaneous coronary intervention, i.e. as primary or salvage therapy for myocardial infarction.
0398	Hartmann products are not available through pharmacy wholesalers. To order please contact the Hartmann Alliance (refer to 'Ordering Hartmann Products' at the foot of the 'Wound Assessment and Dressing Identification' chart at the beginning of this section).
0400	This price is based on special supply arrangements - see Pharmaceutical Benefits Pricing Authority relativity sheet for full details. Relativity sheets are available on the Department of Health and Ageing's internet site (visit www.health.gov.au and search for 'relativity sheets').
0401	Oxaliplatin is not PBS-subsidised for the treatment of patients with stage II (Dukes B) colon cancer.  Oxaliplatin is not PBS-subsidised for the adjuvant treatment of patients with rectal cancer.
0404	Imatinib mesylate in the chronic phase of chronic myeloid leukaemia will only be subsidised for patients who are not receiving concomitant PBS-subsidised interferon alfa therapy.   Patients should be commenced on a dose of imatinib mesylate of 400 mg (base) daily and maintained on a minimum dose of imatinib mesylate of 400 mg (base) daily.  Prescribing of lower doses should be carefully considered.  Continuing therapy is dependent on patients demonstrating a response to imatinib mesylate therapy following the initial 18 months of treatment and at 12 monthly intervals thereafter, irrespective of the daily imatinib mesylate dose received.
0410	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. 
0411	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. 
0415	Any queries concerning the arrangements to prescribe bosentan monohydrate 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 bosentan monohydrate should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
0418	Any queries concerning the arrangements to prescribe iloprost trometamol 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 iloprost trometamol should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
0422	Arrangements to prescribe this item should be made by medical practitioners with Medicare Australia, contact telephone number 1800 700 270.
0425	Patients receiving thalidomide under the PBS listing must be registered in the Pharmion Risk Management Program.
0432	In the adjuvant setting, the recommended treatment duration is 24 weeks.  Capecitabine is not PBS-subsidised for the treatment of patients with stage II (Dukes B) colon cancer.  Capecitabine is not PBS-subsidised for the adjuvant treatment of patients with rectal cancer.
0433	Temozolomide is not PBS-subsidised for use in conjunction with PBS-subsidised carmustine.
0435	Carmustine is not PBS-subsidised for use in conjunction with PBS-subsidised temozolomide.
0451	This drug is not PBS-subsidised for primary prevention of breast cancer.  This drug is not PBS-subsidised for adjuvant hormonal treatment of early breast cancer extended beyond 5 years.
0452	The base-priced drugs in this therapeutic group are cimetidine, famotidine, nizatidine and ranitidine hydrochloride (except ranitidine hydrochloride effervescent tablet 150 mg (base) and syrup 150 mg (base) per 10 mL, 300 mL).
0453	Telephone approvals are limited to 1 month's therapy.
0454	Durogesic is 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).
0459	Any queries concerning the arrangements to prescribe epoprostenol sodium 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 epoprostenol sodium should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
0462	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.
0475	Any queries concerning the arrangements to prescribe trastuzumab 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 trastuzumab 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.
0476	Bioequivalence has been demonstrated between perindopril erbumine 2 mg and perindopril arginine 2.5 mg.
0477	Bioequivalence has been demonstrated between perindopril erbumine 4 mg and perindopril arginine 5 mg.
0478	Bioequivalence has been demonstrated between perindopril erbumine 8 mg and perindopril arginine 10 mg.
0489	The patient or carer must be able to understand and administer the imiquimod dosing regimen.  No applications for increased maximum quantities and/or repeats will be authorised.  Treatment of recurrent (previously treated) lesions will not be authorised.
0490	PBS-subsidised entecavir monohydrate must be used as monotherapy.
0491	Patients should have undergone a liver biopsy at some point since initial diagnosis to obtain histological evidence of chronic hepatitis.  PBS-subsidised entecavir monohydrate must be used as monotherapy.
0493	This drug is not PBS-subsidised for primary prevention of breast cancer.  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.
0498	Rosiglitazone with metformin fixed dose combination tablet is not PBS-subsidised when used in combination with insulin.
0500	The solution concentrate for I.V. infusion 50 mg and powder for I.V. infusion 50 mg (after reconstitution) are bioequivalent.
0501	The solution concentrate for I.V. infusion 100 mg and powder for I.V. infusion 100 mg (after reconstitution) are bioequivalent.
0503	The concentrated injection 15 mg and powder for I.V. infusion 15 mg (after reconstitution) are bioequivalent.
0504	The concentrated injection 30 mg and powder for I.V. infusion 30 mg (after reconstitution) are bioequivalent.
0505	The concentrated injection 90 mg and powder for I.V. infusion 90 mg (after reconstitution) are bioequivalent.
0507	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.   Authority approval requirements.  For the purposes of assessing response to PBS-subsidised treatment with imatinib mesylate, 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 as follows:  (i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, 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) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response or peripheral blood bcr-abl level of less than 1% at between 10 and 12 months (patients in whom a major cytogenetic response or peripheral blood bcr-abl level of less than 1% is demonstrable by 18 months may also receive authorisation for a further 12 months of treatment); and  (iii) 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.   For each authority application where eligibility for continuing PBS-subsidised treatment is to be demonstrated, a copy of the cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or a copy of the quantitative PCR indicating the relative level of bcr-abl transcript in the peripheral blood using the international scale, must be submitted as described in (i) to (iii) above.  For bone marrow analyses, where the standard karyotyping conducted at the time of application is not informative, a copy of a cytogenetic analysis conducted on the bone marrow using FISH with bcr-abl specific probe must be submitted with the authority application.  A copy of the non-informative standard karyotype analysis must be included with the authority application.   Where a patient has previously received PBS-subsidised treatment with imatinib mesylate, 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 criteria for continuing treatment.
0508	Any queries concerning the arrangements to prescribe sildenafil citrate 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 sildenafil citrate should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
0511	TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS   The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and infliximab for adult patients with active ankylosing spondylitis. Where the term 'tumour necrosis factor (TNF) alfa antagonist' appears in the following NOTES and restrictions, it refers to adalimumab, etanercept and infliximab only.   A patient is eligible for PBS-subsidised treatment with only 1 of the 3 TNF-alfa antagonists 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 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 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 TNF-alfa antagonist 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 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 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 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 March 2007.   (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 etanercept and adalimumab and 18 weeks of treatment for infliximab.   From 1 March 2007, 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 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.   (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 to an alternate TNF-alfa antagonist 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 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 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 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 of the BASDAI, ESR and/or CRP 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.   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.  However, this is not required for any subsequent BASDAI results for these patients, nor for patients who were 'grandfathered' on to TNF-alfa antagonist treatment.   To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be 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 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 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.   (5)  Patients 'grandfathered' onto PBS-subsidised treatment with adalimumab.   A patient who commenced treatment with adalimumab for active ankylosing spondylitis prior to 1 November 2006 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.   Where pre-TNF-alfa antagonist treatment baselines cannot be provided, the following criteria must be met to demonstrate a response to treatment:  The BASDAI score must be either:  (i) no more than 20% greater than the score included in the initial application for PBS-subsidised treatment; or  (ii) no greater than 2.  AND  One of the following:  (a) an ESR measurement no greater than 25 mm per hour; or  (b) a CRP measurement no greater than 10 mg per L.   '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.
0512	TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS   The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and infliximab for adult patients with active ankylosing spondylitis. Where the term 'tumour necrosis factor (TNF) alfa antagonist' appears in the following NOTES and restrictions, it refers to adalimumab, etanercept and infliximab only.   A patient is eligible for PBS-subsidised treatment with only 1 of the 3 TNF-alfa antagonists 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 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 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 TNF-alfa antagonist 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 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 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 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 March 2007.   (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 etanercept and adalimumab and 18 weeks of treatment for infliximab.   From 1 March 2007, 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 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.   (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 to an alternate TNF-alfa antagonist 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 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 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 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 of the BASDAI, ESR and/or CRP 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.   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.  However, this is not required for any subsequent BASDAI results for these patients, nor for patients who were 'grandfathered' on to TNF-alfa antagonist treatment.   To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be 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 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 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.   (5)  Patients 'grandfathered' onto PBS-subsidised treatment with etanercept.   From 1 March 2007, a patient who commenced treatment with etanercept for active ankylosing spondylitis prior to 1 July 2004 and who was 'grandfathered' onto PBS-subsidised therapy, and who continues to receive treatment in the same treatment cycle, will have further applications for treatment with etanercept assessed under the continuing treatment restriction.   Where pre-TNF-alfa antagonist treatment baselines were not provided, the following criteria must be met to demonstrate a response to treatment:  The BASDAI score must be either:  (i) no more than 20% greater than the score included in the initial application for PBS-subsidised treatment; or  (ii) no greater than 2.  AND  One of the following:  (a) an ESR measurement no greater than 25 mm per hour; or  (b) a CRP measurement no greater than 10 mg per L.   '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.
0513	TREATMENT OF ADULT PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS   The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab, etanercept and infliximab for adult patients with active ankylosing spondylitis. Where the term 'tumour necrosis factor (TNF) alfa antagonist' appears in the following NOTES and restrictions, it refers to adalimumab, etanercept and infliximab only.   A patient is eligible for PBS-subsidised treatment with only 1 of the 3 TNF-alfa antagonists 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 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 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 TNF-alfa antagonist 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 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 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 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 March 2007.   (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 etanercept and adalimumab and 18 weeks of treatment for infliximab.   From 1 March 2007, 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 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.   (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 to an alternate TNF-alfa antagonist 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 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 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 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 of the BASDAI, ESR and/or CRP 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.   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.  However, this is not required for any subsequent BASDAI results for these patients, nor for patients who were 'grandfathered' on to TNF-alfa antagonist treatment.   To ensure consistency in determining response, the same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be 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 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 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.   (5)  Patients 'grandfathered' onto PBS-subsidised treatment with infliximab.   From 1 March 2007, a patient who commenced treatment with infliximab for active ankylosing spondylitis prior to 1 March 2004 and who was 'grandfathered' onto PBS-subsidised therapy, and who continues to receive treatment in the same treatment cycle, will have further applications for treatment with infliximab assessed under the continuing treatment restriction.   Where pre-TNF-alfa antagonist treatment baselines were not provided, the following criteria must be met to demonstrate a response to treatment:  The BASDAI score must be either:  (i) no more than 20% greater than the score included in the initial application for PBS-subsidised treatment; or  (ii) no greater than 2.  AND  One of the following:  (a) an ESR measurement no greater than 25 mm per hour; or  (b) a CRP measurement no greater than 10 mg per L.   '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.
0520	Any queries concerning the arrangements to prescribe gefitinib may be directed to Medicare Australia on 1800 700 270.   Written applications for authority to prescribe gefitinib should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
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.
0522	Arrangements to prescribe this item should be made by medical practitioners with Medicare Australia, contact telephone number 1800 700 270.
0524	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).   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   Further prescribing information is on the Medicare Australia website at www.medicareaustralia.gov.au.
0525	Any queries concerning the arrangements to prescribe anakinra 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 anakinra 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.
0526	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).   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   Further prescribing information is on the Medicare Australia website at www.medicareaustralia.gov.au.
0527	Any queries concerning the arrangements to prescribe efalizumab 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 efalizumab should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
0528	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).   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   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.
0536	No applications for increased maximum quantities will be authorised. Prescribers should advise Medicare Australia of the number of cycles planned when requesting approval for repeats.
0537	Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:  (a) clinical conditions with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or  (b) red cell transfusion within the previous 3 months.  A patient in these circumstances will be eligible for treatment where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests.  The results of this blood glucose monitoring, which must be no more than 4 months old at the time of initiation of glitazone therapy, must be documented in the patient's medical records.
0539	Pioglitazone hydrochloride is not PBS-subsidised as monotherapy.   Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:  (a) clinical conditions with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or  (b) red cell transfusion within the previous 3 months.  A patient in these circumstances will be eligible for treatment where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests.  The results of this blood glucose monitoring, which must be no more than 4 months old at the time of initiation of glitazone therapy, must be documented in the patient's medical records.
0541	Rosiglitazone maleate is not PBS-subsidised as monotherapy.   Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:  (a) clinical conditions with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or  (b) red cell transfusion within the previous 3 months.  A patient in these circumstances will be eligible for treatment where blood glucose monitoring over a 2 week period shows blood glucose levels greater than 10 mmol per L in more than 20% of tests.  The results of this blood glucose monitoring, which must be no more than 4 months old at the time of initiation of glitazone therapy, must be documented in the patient's medical records.
0543	The base-priced drugs in this therapeutic group are amlodipine, felodipine and nifedipine (except nifedipine controlled release tablet 20 mg).
0544	Symbicort 400/12 is not recommended nor PBS-subsidised for use as 'maintenance and reliever' therapy.
0545	Seretide is not indicated for the initiation of bronchodilator therapy in COPD.
0546	Bioequivalence has been demonstrated between the tablet containing 5 mg amlodipine (as besylate) and the tablet containing 5 mg amlodipine (as maleate).
0547	Bioequivalence has been demonstrated between the tablet containing 10 mg amlodipine (as besylate) and the tablet containing 10 mg amlodipine (as maleate).
0548	Any queries concerning the arrangements to prescribe rituximab 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 rituximab 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.
0551	For immunisation of adults and children aged greater than or equal to 8 years.
0552	This drug is not PBS-subsidised for primary prevention of breast cancer.  This drug is not PBS-subsidised for adjuvant hormonal treatment of early breast cancer extended beyond 5 years.  This drug is not PBS-subsidised for extended adjuvant early breast cancer treatment where the total duration of letrozole (or any other aromatase inhibitor) treatment extends beyond 5 years.
0556	Bioequivalence has been demonstrated between perindopril erbumine/indapamide hemihydrate tablet 4 mg-1.25 mg and perindopril arginine/indapamide hemihydrate tablet 5 mg-1.25 mg.
0559	Bioequivalence has been demonstrated between omeprazole tablet 20 mg and omeprazole tablet 20 mg (as magnesium).
0560	Helicobacter pylori eradication therapy should be considered.   No applications for increased repeats will be authorised.
0561	Bioequivalence has been demonstrated between doxycycline tablet 100 mg (as hydrochloride) and doxycycline tablet 100 mg (as monohydrate).
0562	Bioequivalence has been demonstrated between doxycycline tablet 50 mg (as hydrochloride) and doxycycline tablet 50 mg (as monohydrate).
0564	A maximum of 10 cycles of treatment with docetaxel will be authorised under this restriction.
0566	Any queries concerning the arrangements to prescribe bortezomib 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 bortezomib should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
0567	Authorities for increased maximum quantities, up to a maximum of 52, may be authorised.
0568	Allogeneic stem cell transplantation is the preferred therapy for eligible patients achieving a complete remission of Philadelphia positive acute lymphoblastic leukaemia.
0570	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.   Any queries concerning patients who are enrolled on the Dasatinib 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 dasatinib should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
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.
0572	Ramipril 1.25 mg tablets and capsules are bioequivalent.
0573	Ramipril 10 mg tablets and capsules are bioequivalent.
0574	Ramipril 2.5 mg tablets and capsules are bioequivalent.
0575	Ramipril 5 mg tablets and capsules are bioequivalent.
0576	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 efalizumab, etanercept and infliximab, 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 efalizumab, etanercept and infliximab.   From 1 December 2007, all patients will be able to commence a 'Biological Treatment Cycle' (Cycle), where they may trial efalizumab, etanercept or infliximab 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 December 2007 is considered to be in their first Cycle as of 1 December 2007.   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 December 2007, 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 December 2007.   Initial treatment with efalizumab consists of 16 weeks of therapy, with infliximab consists of 22 weeks of therapy, and with etanercept consists of 12 weeks of active therapy followed by a biological treatment-free period of at least 12 weeks.  Response to treatment for all 3 agents must be assessed after 12 weeks of treatment.   Following demonstration of response to initial treatment, these biological agents are available as continuing therapy.  Ongoing access to continuing treatment is available for as long as the response to therapy is sustained.  In the case of efalizumab and infliximab, continuing treatment consists of 24 weeks of continuous active treatment.  In the case of etanercept, continuing treatment consists of 12 weeks of active therapy followed by a biological treatment-free period of at least 12 weeks.   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 December 2007.   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); and  (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]; and  (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 for non-grandfather patients will be limited to provide for a maximum of 16 weeks of therapy in the case of efalizumab, 12 weeks of therapy in the case of etanercept, and 22 weeks of treatment in the case of infliximab.  Approval will be based on the criteria included in the relevant initial treatment restriction.   Grandfather patients (Infliximab only).   Applications for patients who commenced treatment with infliximab prior to 7 March 2007, may apply for initial PBS-subsidised treatment as continuing therapy 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 a 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.  Approval will be based on the criteria included in the relevant restriction.   (2)  Assessment of response to initial treatment.   When prescribing efalizumab or infliximab, where the initial treatment course is for 16 or 22 weeks respectively, 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 efalizumab or infliximab.  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.   Applications for continuing treatment with efalizumab or infliximab must also be submitted to Medicare Australia prior to the completion of this initial course of therapy to ensure continuity of treatment for those patients who meet the continuation criterion and wish to continue on treatment with either efalizumab or infliximab.   When prescribing etanercept, a PASI assessment must be conducted at the completion of the 12 week initial treatment course.  This assessment, which will be used to determine eligibility for future treatment according to the criterion included in the relevant continuing treatment restriction, must be submitted to Medicare Australia 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 Medicare Australia within these timeframes, the patient will be deemed to have failed to respond to treatment with etanercept.  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.   As stated above, following the completion of an initial treatment course of efalizumab or infliximab to which an adequate response has been demonstrated, patients may qualify to receive up to 24 weeks of continuing treatment with efalizumab or infliximab.  Patients are eligible to continue to receive continuous treatment with efalizumab or infliximab in 24 week courses providing they continue to sustain a response.   For second and subsequent courses of PBS-subsidised treatment with efalizumab or infliximab 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.   At the completion of an initial 12 week treatment course of etanercept to which an adequate response has been demonstrated, followed by a biological treatment-free period of at least 12 weeks, patients may qualify to receive continuing treatment with etanercept.  Continuing treatment is available in the form of 12 weeks of active etanercept treatment followed by a biological treatment-free period of at least 12 weeks.  Patients are eligible to receive continuing treatment with etanercept on this cyclical basis, for as long as they continue to sustain a response.  Continuing applications must be submitted at least 12 weeks after cessation of the most recent course of etanercept treatment.   A PASI assessment must be conducted for each course of continuing treatment for each biological agent, according to the requirements set out in the relevant restriction.  Assessment of response to a course of PBS-subsidised therapy must be submitted to Medicare Australia no later than 1 month from the date that course was completed or treatment was ceased.   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.
0577	(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 in the same Cycle.   Patients who commenced treatment with infliximab prior to 7 March 2007 access these interchangeability arrangements in the same way as patients who have not.   PBS subsidy does not allow for patients to receive treatment with another PBS-subsidised biological agent during the required 12 week biological treatment-free period applying to patients who have demonstrated a response to their most recent course of etanercept.  This means that patients who have demonstrated a response to a 12 week course of etanercept must have a PBS-subsidised biological therapy treatment-free period of at least 12 weeks, immediately following this course of treatment, before swapping to efalizumab or infliximab.  Patients who fail to respond to etanercept and who qualify and wish to try a course of efalizumab or infliximab, may do so without having to have any treatment-free period.   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.   For new patients and patients commencing a new Cycle, the first baseline PASI assessment must be conducted, preferably while the patient is still receiving their most recent prior therapy, but no later than 1 month following cessation of such therapy, as outlined in the relevant restriction.  This is not required for any subsequent PASI scores provided for these patients within the same Cycle, nor for patients who received initial PBS-subsidised therapy under a 'grandfather' restriction.   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.
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.
0581	TREATMENT OF ADULT PATIENTS WITH SEVERE ACTIVE PSORIATIC ARTHRITIS   The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of the biological agents (adalimumab, etanercept 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 the following NOTES and restrictions, it only refers to adalimumab, etanercept and infliximab.   From 1 August 2006, all patients will be able to commence a 'Biological Treatment Cycle' (Cycle), where they may trial adalimumab, etanercept or infliximab without having to meet the initial treatment criteria, that is they will not need 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 5-year 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 after 1 August 2006.   (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 all agents except for infliximab, for which a maximum of 22 weeks will be authorised.  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 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, patients will be deemed to have failed to respond to treatment with that biological agent.   Grandfather patients.   Applications for patients who commenced treatment with etanercept prior to 17 March 2005 or adalimumab and infliximab prior to 16 March 2006, may apply for initial PBS-subsidised treatment as continuing therapy 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 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, 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.   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.   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.   Medicare Australia 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 authority is submitted within a treatment Cycle 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. 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 re-qualify for initial treatment with respect to both the indices of disease severity.  Patients must have received treatment with methotrexate or 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.
0583	To be used in conjunction with the scalp cleanser salicylic acid with coal tar solution and pine tar (code 4447C).
0584	Only one course of PBS-subsidised varenicline tartrate will be authorised per year.  The period between commencing a course of varenicline tartrate and bupropion hydrochloride must be at least 6 months.  A course of treatment with varenicline tartrate is 12 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.
0585	Patients should have undergone a liver biopsy at some point since initial diagnosis to obtain histological evidence of chronic hepatitis.  Patients may receive treatment in combination with lamivudine but not with other PBS-subsidised antihepadnaviral therapy.
0586	Any queries concerning the arrangements to prescribe abatacept 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 abatacept 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.
0587	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, etanercept, infliximab), the chimeric anti-CD20 monoclonal antibody (rituximab), the interleukin-1 inhibitor (anakinra) 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 infliximab, anakinra, rituximab and abatacept 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 only eligible to receive PBS-subsidised etanercept and adalimumab.   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.   From 1 March 2008, under the PBS, all patients will be able to commence a Treatment Cycle where they may trial PBS-subsidised bDMARD agents without having to experience a disease flare when swapping to an 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 2008 is considered to be in their first Cycle as of 1 March 2008.   Within the same Treatment Cycle, a patient cannot trial and fail, or cease to respond to, the same PBS-subsidised bDMARD more than once.   Once a patient has either failed or ceased to respond to treatment 3 times, they are deemed to have completed a Treatment Cycle and they must have, at a minimum, a 5-year break in PBS-subsidised bDMARD therapy before they are eligible to commence the next Cycle.   For patients who have failed PBS-subsidised treatment with 3 bDMARDs prior to 1 March 2008 please contact Medicare Australia on 1800 700 270.   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.   If patients fail to respond to a particular bDMARD within a single Treatment Cycle, they are not eligible to receive further PBS-subsidised treatment with that drug until they commence the next Cycle.   (1) How to prescribe PBS-subsidised bDMARD therapy after 1 March 2008.   (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, excluding rituximab (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).   Initial treatment authorisations will be limited to provide a maximum of 16 weeks of therapy for etanercept, adalimumab, anakinra and abatacept, 22 weeks of therapy for infliximab and 2 infusions of rituximab.   From 1 March 2008, 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.   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 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 joint count) or the prior non-bDMARD therapy requirements.  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 within the same Treatment Cycle.   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.  
0588	(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 within a Treatment Cycle 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.   The baseline joint and blood counts should be performed whilst the patient is still on treatment or within 1 month of ceasing prior treatment.   (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 non-biological DMARD, at an adequate dose, for a minimum of 3 months at the time the ESR and/or CRP levels and the active joint count are measured.   (5)  Patients 'grandfathered' onto PBS-subsidised treatment with rituximab or abatacept.   From 1 March 2008, a patient who commenced treatment with rituximab for severe rheumatoid arthritis prior to 7 March 2007 or abatacept for severe rheumatoid arthritis prior to 1 November 2007 and who was 'grandfathered' on to PBS-subsidised therapy, and who continues to receive treatment in the same Treatment Cycle, will have further applications for treatment with rituximab or abatacept assessed under the continuing treatment restriction.   A patient may only qualify for PBS-subsidised treatment under this criterion once.  A maximum of 24 weeks of treatment with abatacept will be authorised under this criterion.   '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 applies to a new patient.  See 'Re-commencement of treatment after a 5-year break in PBS-subsidised therapy' above for further details.
0589	Any queries concerning the arrangements to prescribe sitaxentan sodium 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 sitaxentan sodium should be forwarded to:   Medicare Australia  Prior Written Approval of Specialised Drugs  Reply Paid 9826  GPO Box 9826  HOBART TAS 7001
0592	No applications for increased repeats will be authorised.  Telephone approvals are limited to 1 month's therapy.
0602	Any queries concerning the arrangements to prescribe lapatinib may be directed to Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).   Lapatinib should not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% or with symptomatic heart failure.  Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, prior to seeking the initial authority approval and then at 3 monthly intervals during treatment.   Lapatinib is not PBS-subsidised when used in combination with Commonwealth-subsidised trastuzumab.  Once PBS-subsidised lapatinib has been commenced, a patient cannot subsequently receive Commonwealth-subsidised trastuzumab.   If disease progression occurs, the prescribing doctor must contact Medicare Australia within one week on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) and lapatinib treatment must be ceased immediately.
0603	Treatment with trastuzumab for metastatic disease is defined as trastuzumab administered alone or in combination with chemotherapy for at least 6 weeks at standard doses.
0604	These guidelines may be obtained from the Department of Health and Ageing's internet site at http://www.health.gov.au/internet/main/publishing.nsf/Content/ pbs-hghguidelines-contents, 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
0605	During the titration phase, intact PTH should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.  During the titration phase, approval will be limited to sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.   During the maintenance phase, approval will be limited to provide sufficient quantity for 4 weeks treatment up to a maximum of 6 months supply for doses between 30 and 180 mg per day according to the patient's response and tolerability.  Intact PTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.   "Sustained" means the abnormality was detected on at least 2 blood samples collected over a period of 2 to 4 months.
0606	During the titration phase, intact PTH should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.  During the titration phase, approval will be limited to sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.   During the maintenance phase, approval will be limited to provide sufficient quantity for 4 weeks treatment up to a maximum of 6 months supply for doses between 30 and 180 mg per day according to the patient's response and tolerability.  Intact PTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
0607	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.
0618	No applications for increased maximum quantities for the 500 mg vial will be authorised.
0620	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.   Any queries concerning patients who are enrolled on the Nilotinib 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).   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
0623	Bosentan monohydrate is not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70% of that predicted.   Bosentan monohydrate is not PBS-subsidised when used in combination with PBS-subsidised iloprost trometamol, PBS-subsidised epoprostenol sodium, PBS-subsidised sildenafil citrate or PBS-subsidised sitaxentan sodium.   The following provides some explanatory notes regarding the availability of PBS-subsidised treatment with:  (a) bosentan monohydrate, of primary pulmonary hypertension, pulmonary arterial hypertension secondary to scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology), in patients with disease of WHO Functional Class III or IV severity; AND  (b) iloprost trometamol, of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III or IV severity; AND  (c) epoprostenol sodium, of primary pulmonary hypertension, in patients with disease of WHO Functional Class III or IV severity; AND  (d) sildenafil citrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity; AND  (e) sitaxentan sodium, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity.   Adult patients:  From 1 April 2008, adult patients with primary pulmonary hypertension will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to scleroderma will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 4 drugs, they may swap between bosentan monohydrate, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to connective tissue disease other than scleroderma will be able to access, through the PBS, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 3 drugs, they may swap between iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Patients with drug-induced pulmonary arterial hypertension are only eligible for treatment with iloprost trometamol.  They may not swap to bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium.   Patients with pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are only eligible for treatment with bosentan monohydrate. They may not swap to epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium.   Patients under 18 years of age:  From 1 April 2008, patients aged less than 18 years with primary pulmonary hypertension are eligible to receive PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   1. Definition of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology).   Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension, pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, or pulmonary arterial hypertension associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger's physiology) are defined as follows:  (i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or  (ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or  (iii) where a right heart catheter cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.   2. Definition of WHO Functional Class III or IV disease severity.   (a) WHO Functional Class III disease severity is defined as follows:  Patients with pulmonary hypertension resulting in marked limitation of physical activity who are comfortable at rest and on ordinary physical activity experience dyspnoea or fatigue, chest pain or near syncope.  (b) WHO Functional Class IV disease severity is defined as follows:  Patients with the inability to carry out any physical activity without symptoms.  These patients manifest signs of right heart failure. Dyspnoea and/or fatigue may even be present at rest.  Discomfort is increased by any physical activity.   3. Designated hospitals.   Refer to the Medicare Australia website at www.medicareaustralia.gov.au for a list of designated hospitals.   4. Test requirements to establish baseline for initiation of treatment and response to treatment for continuation of treatment.   (a) Initiation of treatment.  The first written application for PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium should be accompanied by the results of a right heart catheter (RHC) composite assessment, plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.   Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments;  (2) RHC composite assessment plus 6MWT;  (3) RHC composite assessment only.   In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to Medicare Australia for consideration based on the results of the following test combinations, which are listed in descending order of preference:  (1) ECHO composite assessment plus 6MWT;  (2) ECHO composite assessment only.   Where fewer than 3 tests are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application.  
0624	Where patients were initiated on PBS-subsidised treatment either with bosentan monohydrate on or after 1 March 2004, with iloprost trometamol on or after 1 April 2005, with epoprostenol sodium on or after 1 August 2006, with sildenafil citrate on or after 1 March 2007, with sitaxentan sodium on or after 1 April 2008, or with bosentan monohydrate (for PAH associated with congenital systemic-to-pulmonary shunt) on or after 1 August 2008, the test results provided with the initial application must be no more than 2 months old at the time of application.  These results will form the baseline against which response assessments will be made.   Where patients received treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium prior to being commenced on PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, the test requirements above still apply.  The results that will form the baseline against which response assessments will be made will be those measured at the time patients commenced non-PBS-subsidised treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever of the 5 drugs the patient received first.   (b) Continuation of treatment.  The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments plus 6MWT;  (2) RHC plus ECHO composite assessments;  (3) RHC composite assessment plus 6MWT;  (4) ECHO composite assessment plus 6MWT;  (5) RHC composite assessment only;  (6) ECHO composite assessment only.   The results of the same tests as conducted at baseline should be provided with each written continuing treatment application (i.e. every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted.  In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a reason why the test(s) could not be conducted must be provided with the application.   The test(s) results provided with the application for continuing treatment must be no more than 2 months old at the time of application.   5. Definition of response to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, sitaxentan sodium or prior vasodilator treatment.   For adult patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For patients aged less than 18 years, response to treatment is defined as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   6. Authority approval requirements.  [The following 2 sections are only relevant to the PBS listing of bosentan monohydrate.  The requirements specific to iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium are given in parts 6 and 7 of the NOTE included in the iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium Schedule entry respectively.]   (a) Initiation of PBS-subsidised treatment with bosentan monohydrate, where the patient has not received prior PBS-subsidised treatment with iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium.  All applications for initial treatment must be made in writing, must include 2 separate authority prescriptions and must be submitted to Medicare Australia for authorisation. The total duration of initial PBS-subsidised treatment that will be approved with this first written application is up to 6 months.   Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the Therapeutic Goods Administration (TGA)-approved Product Information.  No repeats will be authorised for this prescription.  The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Where the 62.5 mg tablet strength is required, please contact Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) for further advice.  Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats. The approved second authority prescription will be returned to the prescriber by Medicare Australia 2 weeks after the date of the approval of the first authority prescription, to allow for the uninterrupted completion of the 6 month initial treatment course. Medicare Australia will contact prescribers prior to dispatch of the second authority prescription to confirm the tablet strength required for the patient.   (b) Continuation of treatment.  Written applications for continuing treatment must be submitted to Medicare Australia for authorisation every 6 months. Approvals will be limited to provide sufficient supply for up to a maximum of 6 months of treatment, based on the dosage recommendations in the TGA-approved Product Information.   Applications for continuing treatment will only be approved for patients who have currently demonstrated a response to treatment with bosentan monohydrate.   The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. Applications for continuing treatment with bosentan monohydrate should be made prior to the completion of the 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.   (c) Swapping between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium.  For eligible patients, applications to swap between these 5 drugs must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.   It is important that patients are assessed for response to every course of treatment approved within the timeframes specified in the relevant restriction, in order to maximise the choice of treatment.   To avoid confusion, applications for patients who wish to swap to an alternate treatment should be accompanied by the previously approved authority prescription, or remaining repeats, for the treatment the patient is ceasing.   (d) Cessation of treatment.  Patients who fail to demonstrate a response to PBS-subsidised bosentan monohydrate treatment at the times where an assessment is required must cease PBS-subsidised bosentan monohydrate therapy.   For patients ceasing treatment, approval will only be granted to provide sufficient supply of the 62.5 mg tablet strength to allow gradual dose reduction over a period of no more than 1 month duration. Prescribers should telephone Medicare Australia on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) to receive authorisation for this final supply and to ensure no unintended break in treatment occurs.   7. Re-treatment with bosentan monohydrate.   Patients who do not respond to treatment are not eligible to receive further PBS-subsidised treatment with bosentan monohydrate under any circumstances.   8. Further information.   A tabulated representation of the above information and the restriction can be obtained from the Medicare Australia website at www.medicareaustralia.gov.au.
0625	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).
0626	Epoprostenol sodium is not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70% of that predicted.   Epoprostenol sodium is not PBS-subsidised when used in combination with PBS-subsidised bosentan monohydrate, PBS-subsidised iloprost trometamol, PBS-subsidised sildenafil citrate or PBS-subsidised sitaxentan sodium.   The following provides some explanatory notes regarding the availability of PBS-subsidised treatment with:  (a) bosentan monohydrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, in patients with disease of WHO Functional Class III or IV severity; AND  (b) iloprost trometamol, of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III or IV severity; AND  (c) epoprostenol sodium, of primary pulmonary hypertension, in patients with disease of WHO Functional Class III or IV severity; AND  (d) sildenafil citrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity; AND  (e) sitaxentan sodium, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity.   Adult patients:  From 1 April 2008, adult patients with primary pulmonary hypertension will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to scleroderma will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 4 drugs, they may swap between bosentan monohydrate, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to connective tissue disease other than scleroderma will be able to access, through the PBS, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 3 drugs, they may swap between iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Patients with drug-induced pulmonary arterial hypertension are only eligible for treatment with iloprost trometamol.  They may not swap to bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium.   Patients under 18 years of age:  From 1 April 2008, patients aged less than 18 years with primary pulmonary hypertension are eligible to receive PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   1. Definition of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma.   Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, are defined as follows:  (i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or  (ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or  (iii) where a right heart catheter cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.   2. Definition of WHO Functional Class III or IV disease severity.   (a) WHO Functional Class III disease severity is defined as follows:  Patients with pulmonary hypertension resulting in marked limitation of physical activity who are comfortable at rest and on ordinary physical activity experience dyspnoea or fatigue, chest pain or near syncope.  (b) WHO Functional Class IV disease severity is defined as follows:  Patients with the inability to carry out any physical activity without symptoms.  These patients manifest signs of right heart failure. Dyspnoea and/or fatigue may even be present at rest.  Discomfort is increased by any physical activity.   3. Designated hospitals.   Refer to the Medicare Australia website at www.medicareaustralia.gov.au for a list of designated hospitals.   4. Test requirements to establish baseline for initiation of treatment and response to treatment for continuation of treatment.   (a) Initiation of treatment.  The first written application for PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium should be accompanied by the results of a right heart catheter (RHC) composite assessment, plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.   Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments;  (2) RHC composite assessment plus 6MWT;  (3) RHC composite assessment only.   In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to Medicare Australia for consideration based on the results of the following test combinations, which are listed in descending order of preference:  (1) ECHO composite assessment plus 6MWT;  (2) ECHO composite assessment only.   Where fewer than 3 tests are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application.  
0627	Where patients were initiated on PBS-subsidised treatment either with bosentan monohydrate on or after 1 March 2004, with iloprost trometamol on or after 1 April 2005, with epoprostenol sodium on or after 1 August 2006, with sildenafil citrate on or after 1 March 2007, with sitaxentan sodium on or after 1 April 2008, or with bosentan monohydrate (for PAH associated with congenital systemic-to-pulmonary shunt) on or after 1 August 2008, the test results provided with the initial application must be no more than 2 months old at the time of application.  These results will form the baseline against which response assessments will be made.   Where patients received treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium prior to being commenced on PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, the test requirements above still apply.  The results that will form the baseline against which response assessments will be made will be those measured at the time patients commenced non-PBS-subsidised treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever of the 5 drugs the patient received first.   (b) Continuation of treatment.  The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments plus 6MWT;  (2) RHC plus ECHO composite assessments;  (3) RHC composite assessment plus 6MWT;  (4) ECHO composite assessment plus 6MWT;  (5) RHC composite assessment only;  (6) ECHO composite assessment only.   The results of the same tests as conducted at baseline should be provided with each written continuing treatment application (i.e. every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted.  In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a reason why the test(s) could not be conducted must be provided with the application.   The test(s) results provided with the application for continuing treatment must be no more than 2 months old at the time of application.   5. Definition of response to epoprostenol sodium, bosentan monohydrate, iloprost trometamol, sildenafil citrate, sitaxentan sodium or prior vasodilator treatment.   For adult patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For patients aged less than 18 years, response to treatment is defined as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   6. Authority approval requirements.  [The following 2 sections are only relevant to the PBS listing of epoprostenol sodium.  The requirements specific to bosentan monohydrate, iloprost trometamol, sildenafil citrate and sitaxentan sodium are given in parts 6 and 7 of the NOTE included in the bosentan monohydrate, iloprost trometamol, sildenafil citrate and sitaxentan sodium Schedule entry respectively.]   (a) Initiation of PBS-subsidised treatment with epoprostenol sodium, where the patient has not received prior PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium.  All applications for initial treatment must be made in writing, must include an authority prescription and must be submitted to Medicare Australia for authorisation.  The total duration of initial PBS-subsidised treatment that will be approved with this first written application is up to 6 months, based on the dosage recommendations in the TGA-approved Product Information.   (b) Continuation of treatment.  Written applications for continuing treatment must be submitted to Medicare Australia for authorisation every 6 months. Approvals will be limited to provide sufficient supply for up to a maximum of 6 months of treatment, based on the dosage recommendations in the TGA-approved Product Information.   Applications for continuing treatment will only be approved for patients who have currently demonstrated a response to treatment with epoprostenol sodium.   The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. Applications for continuing treatment with epoprostenol sodium should be made prior to the completion of the 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.   (c) Swapping between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium.  For eligible patients, applications to swap between these 5 drugs must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.   It is important that patients are assessed for response to every course of treatment approved within the timeframes specified in the relevant restriction, in order to maximise the choice of treatment.   To avoid confusion, applications for patients who wish to swap to an alternate treatment should be accompanied by the previously approved authority prescription, or remaining repeats, for the treatment the patient is ceasing.   (d) Cessation of treatment.  Patients who fail to demonstrate a response to PBS-subsidised epoprostenol sodium treatment at the times where an assessment is required must cease PBS-subsidised epoprostenol sodium therapy.   7. Re-treatment with epoprostenol sodium.   Patients who do not respond to treatment are not eligible to receive further PBS-subsidised treatment with epoprostenol sodium under any circumstances.   8. Further information.   A tabulated representation of the above information and the restriction can be obtained from the Medicare Australia website at www.medicareaustralia.gov.au.
0628	Iloprost trometamol is not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70% of that predicted.   Iloprost trometamol is not PBS-subsidised when used in combination with PBS-subsidised bosentan monohydrate, PBS-subsidised epoprostenol sodium, PBS-subsidised sildenafil citrate or PBS-subsidised sitaxentan sodium.   The following provides some explanatory notes regarding the availability of PBS-subsidised treatment with:  (a) bosentan monohydrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, in patients with disease of WHO Functional Class III or IV severity; AND  (b) iloprost trometamol, of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III or IV severity; AND  (c) epoprostenol sodium, of primary pulmonary hypertension, in patients with disease of WHO Functional Class III or IV severity; AND  (d) sildenafil citrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity; AND  (e) sitaxentan sodium, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity.   Adult patients:  From 1 April 2008, adult patients with primary pulmonary hypertension will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to scleroderma will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 4 drugs, they may swap between bosentan monohydrate, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to connective tissue disease other than scleroderma will be able to access, through the PBS, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 3 drugs, they may swap between iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Patients with drug-induced pulmonary arterial hypertension are only eligible for treatment with iloprost trometamol.  They may not swap to bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium.   Patients under 18 years of age:  From 1 April 2008, patients aged less than 18 years with primary pulmonary hypertension are eligible to receive PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   1. Definition of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma.   Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, are defined as follows:  (i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or  (ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or  (iii) where a right heart catheter cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.   2. Definition of WHO Functional Class III or IV disease severity.   (a) WHO Functional Class III disease severity is defined as follows:  Patients with pulmonary hypertension resulting in marked limitation of physical activity who are comfortable at rest and on ordinary physical activity experience dyspnoea or fatigue, chest pain or near syncope.  (b) WHO Functional Class IV disease severity is defined as follows:  Patients with the inability to carry out any physical activity without symptoms.  These patients manifest signs of right heart failure. Dyspnoea and/or fatigue may even be present at rest.  Discomfort is increased by any physical activity.   3. Designated hospitals.   Refer to the Medicare Australia website at www.medicareaustralia.gov.au for a list of designated hospitals.   4. Test requirements to establish baseline for initiation of treatment and response to treatment for continuation of treatment.   (a) Initiation of treatment.  The first written application for PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium should be accompanied by the results of a right heart catheter (RHC) composite assessment, plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.   Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments;  (2) RHC composite assessment plus 6MWT;  (3) RHC composite assessment only.   In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to Medicare Australia for consideration based on the results of the following test combinations, which are listed in descending order of preference:  (1) ECHO composite assessment plus 6MWT;  (2) ECHO composite assessment only.   Where fewer than 3 tests are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application.  
0629	Where patients were initiated on PBS-subsidised treatment either with bosentan monohydrate on or after 1 March 2004, with iloprost trometamol on or after 1 April 2005, with epoprostenol sodium on or after 1 August 2006, with sildenafil citrate on or after 1 March 2007, with sitaxentan sodium on or after 1 April 2008, or with bosentan monohydrate (for PAH associated with congenital systemic-to-pulmonary shunt) on or after 1 August 2008, the test results provided with the initial application must be no more than 2 months old at the time of application.  These results will form the baseline against which response assessments will be made.   Where patients received treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium prior to being commenced on PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, the test requirements above still apply.  The results that will form the baseline against which response assessments will be made will be those measured at the time patients commenced non-PBS-subsidised treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever of the 5 drugs the patient received first.   (b) Continuation of treatment.  The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments plus 6MWT;  (2) RHC plus ECHO composite assessments;  (3) RHC composite assessment plus 6MWT;  (4) ECHO composite assessment plus 6MWT;  (5) RHC composite assessment only;  (6) ECHO composite assessment only.   The results of the same tests as conducted at baseline should be provided with each written continuing treatment application (i.e. every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted.  In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a reason why the test(s) could not be conducted must be provided with the application.   The test(s) results provided with the application for continuing treatment must be no more than 2 months old at the time of application.   5. Definition of response to iloprost trometamol, bosentan monohydrate, epoprostenol sodium, sildenafil citrate, sitaxentan sodium or prior vasodilator treatment.   For adult patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   6. Authority approval requirements.  [The following 2 sections are only relevant to the PBS listing of iloprost trometamol.  The requirements specific to bosentan monohydrate, epoprostenol sodium, sildenafil citrate and sitaxentan sodium are given in parts 6 and 7 of the NOTE included in the bosentan monohydrate, epoprostenol sodium, sildenafil citrate and sitaxentan sodium Schedule entry respectively.]   (a) Initiation of PBS-subsidised treatment with iloprost trometamol, where the patient has not received prior PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium.  All applications for initial treatment must be made in writing, must include an authority prescription and must be submitted to Medicare Australia for authorisation.  The total duration of initial PBS-subsidised treatment that will be approved with this first written application is up to 6 months, based on the dosage recommendations in the TGA-approved Product Information.   (b) Continuation of treatment.  Written applications for continuing treatment must be submitted to Medicare Australia for authorisation every 6 months. Approvals will be limited to provide sufficient supply for up to a maximum of 6 months of treatment, based on the dosage recommendations in the TGA-approved Product Information.   Applications for continuing treatment will only be approved for patients who have currently demonstrated a response to treatment with iloprost trometamol.   The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. Applications for continuing treatment with iloprost trometamol should be made prior to the completion of the 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.   (c) Swapping between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium.  For eligible patients, applications to swap between these 5 drugs must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.   It is important that patients are assessed for response to every course of treatment approved within the timeframes specified in the relevant restriction, in order to maximise the choice of treatment.   To avoid confusion, applications for patients who wish to swap to an alternate treatment should be accompanied by the previously approved authority prescription, or remaining repeats, for the treatment the patient is ceasing.   (d) Cessation of treatment.  Patients who fail to demonstrate a response to PBS-subsidised iloprost trometamol treatment at the times where an assessment is required must cease PBS-subsidised iloprost trometamol therapy.   7. Re-treatment with iloprost trometamol.   Patients who do not respond to treatment are not eligible to receive further PBS-subsidised treatment with iloprost trometamol under any circumstances.   8. Further information.   A tabulated representation of the above information and the restriction can be obtained from the Medicare Australia website at www.medicareaustralia.gov.au.
0630	Sildenafil citrate is not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70% of that predicted.   Sildenafil citrate is not PBS-subsidised when used in combination with PBS-subsidised bosentan monohydrate, PBS-subsidised iloprost trometamol, PBS-subsidised epoprostenol sodium or PBS-subsidised sitaxentan sodium.   The following provides some explanatory notes regarding the availability of PBS-subsidised treatment with:  (a) bosentan monohydrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, in patients with disease of WHO Functional Class III or IV severity; AND  (b) iloprost trometamol, of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III or IV severity; AND  (c) epoprostenol sodium, of primary pulmonary hypertension, in patients with disease of WHO Functional Class III or IV severity; AND  (d) sildenafil citrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity; AND  (e) sitaxentan sodium, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity.   Adult patients:  From 1 April 2008, adult patients with primary pulmonary hypertension will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to scleroderma will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 4 drugs, they may swap between bosentan monohydrate, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to connective tissue disease other than scleroderma will be able to access, through the PBS, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 3 drugs, they may swap between iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Patients with drug-induced pulmonary arterial hypertension are only eligible for treatment with iloprost trometamol.  They may not swap to bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium.   Patients under 18 years of age:  From 1 April 2008, patients aged less than 18 years with primary pulmonary hypertension are eligible to receive PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   1. Definition of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma.   Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, are defined as follows:  (i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or  (ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or  (iii) where a right heart catheter cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.   2. Definition of WHO Functional Class III or IV disease severity.   (a) WHO Functional Class III disease severity is defined as follows:  Patients with pulmonary hypertension resulting in marked limitation of physical activity who are comfortable at rest and on ordinary physical activity experience dyspnoea or fatigue, chest pain or near syncope.  (b) WHO Functional Class IV disease severity is defined as follows:  Patients with the inability to carry out any physical activity without symptoms.  These patients manifest signs of right heart failure. Dyspnoea and/or fatigue may even be present at rest.  Discomfort is increased by any physical activity.   3. Designated hospitals.   Refer to the Medicare Australia website at www.medicareaustralia.gov.au for a list of designated hospitals.   4. Test requirements to establish baseline for initiation of treatment and response to treatment for continuation of treatment.   (a) Initiation of treatment.  The first written application for PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium should be accompanied by the results of a right heart catheter (RHC) composite assessment, plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.   Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments;  (2) RHC composite assessment plus 6MWT;  (3) RHC composite assessment only.   In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to Medicare Australia for consideration based on the results of the following test combinations, which are listed in descending order of preference:  (1) ECHO composite assessment plus 6MWT;  (2) ECHO composite assessment only.   Where fewer than 3 tests are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application.  
0631	Where patients were initiated on PBS-subsidised treatment either with bosentan monohydrate on or after 1 March 2004, with iloprost trometamol on or after 1 April 2005, with epoprostenol sodium on or after 1 August 2006, with sildenafil citrate on or after 1 March 2007, with sitaxentan sodium on or after 1 April 2008, or with bosentan monohydrate (for PAH associated with congenital systemic-to-pulmonary shunt) on or after 1 August 2008, the test results provided with the initial application must be no more than 2 months old at the time of application.  These results will form the baseline against which response assessments will be made.   Where patients received treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium prior to being commenced on PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, the test requirements above still apply.  The results that will form the baseline against which response assessments will be made will be those measured at the time patients commenced non-PBS-subsidised treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever of the 5 drugs the patient received first.   (b) Continuation of treatment.  The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments plus 6MWT;  (2) RHC plus ECHO composite assessments;  (3) RHC composite assessment plus 6MWT;  (4) ECHO composite assessment plus 6MWT;  (5) RHC composite assessment only;  (6) ECHO composite assessment only.   The results of the same tests as conducted at baseline should be provided with each written continuing treatment application (i.e. every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted.  In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a reason why the test(s) could not be conducted must be provided with the application.   The test(s) results provided with the application for continuing treatment must be no more than 2 months old at the time of application.   5. Definition of response to sildenafil citrate, bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sitaxentan sodium or prior vasodilator treatment.   For adult patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For patients aged less than 18 years, response to treatment is defined as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   6. Authority approval requirements.  [The following 2 sections are only relevant to the PBS listing of sildenafil citrate.  The requirements specific to bosentan monohydrate, iloprost trometamol, epoprostenol sodium and sitaxentan sodium are given in parts 6 and 7 of the NOTE included in the bosentan monohydrate, iloprost trometamol, epoprostenol sodium and sitaxentan sodium Schedule entry respectively.]   (a) Initiation of PBS-subsidised treatment with sildenafil citrate, where the patient has not received prior PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sitaxentan sodium.  All applications for initial treatment must be made in writing, must include an authority prescription and must be submitted to Medicare Australia for authorisation.  The total duration of initial PBS-subsidised treatment that will be approved with this first written application is up to 6 months.   (b) Continuation of treatment.  Written applications for continuing treatment must be submitted to Medicare Australia for authorisation every 6 months.  Approvals will be limited to provide sufficient supply for up to a maximum of 6 months of treatment, based on the dosage recommendations in the TGA-approved Product Information.   Applications for continuing treatment will only be approved for patients who have currently demonstrated a response to treatment with sildenafil citrate.   The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. Applications for continuing treatment with sildenafil citrate should be made prior to the completion of the 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.   (c) Swapping between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium.  For eligible patients, applications to swap between these 5 drugs must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.   It is important that patients are assessed for response to every course of treatment approved within the timeframes specified in the relevant restriction, in order to maximise the choice of treatment.   To avoid confusion, applications for patients who wish to swap to an alternate treatment should be accompanied by the previously approved authority prescription, or remaining repeats, for the treatment the patient is ceasing.   (d) Cessation of treatment.  Patients who fail to demonstrate a response to PBS-subsidised sildenafil citrate treatment at the times where an assessment is required must cease PBS-subsidised sildenafil citrate therapy.   7. Re-treatment with sildenafil citrate.   Patients who do not respond to treatment are not eligible to receive further PBS-subsidised treatment with sildenafil citrate under any circumstances.   8. Further information.   A tabulated representation of the above information and the restriction can be obtained from the Medicare Australia website at www.medicareaustralia.gov.au.
0632	Sitaxentan sodium is not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70% of that predicted.   Sitaxentan sodium is not PBS-subsidised when used in combination with PBS-subsidised bosentan monohydrate, PBS-subsidised iloprost trometamol, PBS-subsidised epoprostenol sodium or PBS-subsidised sildenafil citrate.   The following provides some explanatory notes regarding the availability of PBS-subsidised treatment with:  (a) bosentan monohydrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, in patients with disease of WHO Functional Class III or IV severity; AND  (b) iloprost trometamol, of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III or IV severity; AND  (c) epoprostenol sodium, of primary pulmonary hypertension, in patients with disease of WHO Functional Class III or IV severity; AND  (d) sildenafil citrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity; AND  (e) sitaxentan sodium, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in patients with disease of WHO Functional Class III severity.   Adult patients:  From 1 April 2008, adult patients with primary pulmonary hypertension will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to scleroderma will be able to access, through the PBS, bosentan monohydrate, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 4 drugs, they may swap between bosentan monohydrate, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Adult patients with pulmonary arterial hypertension secondary to connective tissue disease other than scleroderma will be able to access, through the PBS, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 3 drugs, they may swap between iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   Patients with drug-induced pulmonary arterial hypertension are only eligible for treatment with iloprost trometamol.  They may not swap to bosentan monohydrate, epoprostenol sodium, sildenafil citrate or sitaxentan sodium.   Patients under 18 years of age:  From 1 April 2008, patients aged less than 18 years with primary pulmonary hypertension are eligible to receive PBS-subsidised treatment with bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate (WHO Class III only) or sitaxentan sodium (WHO Class III only).  Once these patients are approved initial treatment with 1 of these 5 drugs, they may swap between bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium at any time without having to re-qualify for treatment with the alternate agent.  This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.  It also means that no new baseline measurements will be necessary. (New baselines may be submitted where the patient has failed to respond to their current treatment.)   Patients may only swap to bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate or sitaxentan sodium if they have not failed prior PBS-subsidised treatment with that drug.   1. Definition of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma.   Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, are defined as follows:  (i) mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or  (ii) mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or  (iii) where a right heart catheter cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.   2. Definition of WHO Functional Class III or IV disease severity.   (a) WHO Functional Class III disease severity is defined as follows:  Patients with pulmonary hypertension resulting in marked limitation of physical activity who are comfortable at rest and on ordinary physical activity experience dyspnoea or fatigue, chest pain or near syncope.  (b) WHO Functional Class IV disease severity is defined as follows:  Patients with the inability to carry out any physical activity without symptoms.  These patients manifest signs of right heart failure. Dyspnoea and/or fatigue may even be present at rest.  Discomfort is increased by any physical activity.   3. Designated hospitals.   Refer to the Medicare Australia website at www.medicareaustralia.gov.au for a list of designated hospitals.   4. Test requirements to establish baseline for initiation of treatment and response to treatment for continuation of treatment.   (a) Initiation of treatment.  (i) New patients.  The first written application for PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium should be accompanied by the results of a right heart catheter (RHC) composite assessment, plus an echocardiograph (ECHO) composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.   Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments;  (2) RHC composite assessment plus 6MWT;  (3) RHC composite assessment only.   In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to Medicare Australia for consideration based on the results of the following test combinations, which are listed in descending order of preference:  (1) ECHO composite assessment plus 6MWT;  (2) ECHO composite assessment only.   Where fewer than 3 tests are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application.  
0633	Where patients were initiated on PBS-subsidised treatment either with bosentan monohydrate on or after 1 March 2004, with iloprost trometamol on or after 1 April 2005, with epoprostenol sodium on or after 1 August 2006, with sildenafil citrate on or after 1 March 2007, with sitaxentan sodium on or after 1 April 2008, or with bosentan monohydrate (for PAH associated with congenital systemic-to-pulmonary shunt) on or after 1 August 2008, the test results provided with the initial application must be no more than 2 months old at the time of application.  These results will form the baseline against which response assessments will be made.   Where patients received treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium prior to being commenced on PBS-subsidised treatment with the first of either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, the test requirements above still apply.  The results that will form the baseline against which response assessments will be made will be those measured at the time patients commenced non-PBS-subsidised treatment with either bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate or sitaxentan sodium, whichever of the 5 drugs the patient received first.   (ii) Patients who received non-PBS-subsidised treatment with sitaxentan sodium prior to 1 April 2008.  For patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease who were commenced on sitaxentan sodium treatment prior to 1 April 2008 and who have received less than 6 months of treatment with sitaxentan sodium at the time of application, the first application for PBS-subsidised treatment must include, where available, all 3 test results at the time that the patient commenced treatment with sitaxentan sodium, sildenafil citrate, epoprostenol sodium, bosentan monohydrate or iloprost trometamol, whichever was initiated first.   For patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease who were commenced on sitaxentan sodium treatment prior to 1 April 2008 and who have received 6 or more months of treatment at the time of application, the first application for PBS-subsidised treatment must include, where available, all 3 test results at the time that the patient commenced treatment with sitaxentan sodium, sildenafil citrate, epoprostenol sodium, bosentan monohydrate or iloprost trometamol, whichever was initiated first.  The results at the time of application for initial PBS-subsidised treatment must also be provided and must be no older than 3 months.   (b) Continuation of treatment.  The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:  (1) RHC plus ECHO composite assessments plus 6MWT;  (2) RHC plus ECHO composite assessments;  (3) RHC composite assessment plus 6MWT;  (4) ECHO composite assessment plus 6MWT;  (5) RHC composite assessment only;  (6) ECHO composite assessment only.   The results of the same tests as conducted at baseline should be provided with each written continuing treatment application (i.e. every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted.  In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a reason why the test(s) could not be conducted must be provided with the application.   The test(s) results provided with the application for continuing treatment must be no more than 2 months old at the time of application.   5. Definition of response to sitaxentan sodium, sildenafil citrate, bosentan monohydrate, iloprost trometamol, epoprostenol sodium or prior vasodilator treatment.   For adult patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For adult patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   For patients aged less than 18 years, response to treatment is defined as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.   6. Authority approval requirements.  [The following 2 sections are only relevant to the PBS listing of sitaxentan sodium.  The requirements specific to bosentan monohydrate, iloprost trometamol, epoprostenol sodium and sildenafil citrate are given in parts 6 and 7 of the NOTE included in the bosentan monohydrate, iloprost trometamol, epoprostenol sodium and sildenafil citrate Schedule entry respectively.]   (a) Initiation of PBS-subsidised treatment with sitaxentan sodium, where the patient has not received prior PBS-subsidised treatment with bosentan monohydrate, iloprost trometamol, epoprostenol sodium or sildenafil citrate.  All applications for initial treatment must be made in writing, must include an authority prescription and must be submitted to Medicare Australia for authorisation.  The total duration of initial PBS-subsidised treatment that will be approved with this first written application is up to 6 months.   Patients who commence PBS-subsidised sitaxentan sodium treatment after 1 April 2008 and patients who received 6 or more months of sitaxentan sodium treatment prior to 1 April 2008 are eligible to receive up to 6 months of treatment per authority application.   Patients who commenced treatment with sitaxentan sodium prior to 1 April 2008 and who have received less than 6 months of treatment at the time of application are eligible to receive sufficient supply to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised treatment.   All patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to connective tissue disease who commenced treatment with sitaxentan sodium prior to 1 April 2008 will be eligible to commence PBS-subsidised treatment with sitaxentan sodium. Thereafter, to be eligible for further PBS-subsidised supply, these patients must demonstrate a response to sitaxentan sodium treatment, as defined above under definition of response.   (b) Continuation of treatment.  Written applications for continuing treatment must be submitted to Medicare Australia for authorisation every 6 months.  Approvals will be limited to provide sufficient supply for up to a maximum of 6 months of treatment, based on the dosage recommendations in the TGA-approved Product Information.   Applications for continuing treatment will only be approved for patients who have currently demonstrated a response to treatment with sitaxentan sodium.   The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. Applications for continuing treatment with sitaxentan sodium should be made prior to the completion of the 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.   (c) Swapping between bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate and sitaxentan sodium.  For eligible patients, applications to swap between these 5 drugs must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.   It is important that patients are assessed for response to every course of treatment approved within the timeframes specified in the relevant restriction, in order to maximise the choice of treatment.   To avoid confusion, applications for patients who wish to swap to an alternate treatment should be accompanied by the previously approved authority prescription, or remaining repeats, for the treatment the patient is ceasing.   (d) Cessation of treatment.  Patients who fail to demonstrate a response to PBS-subsidised sitaxentan sodium treatment at the times where an assessment is required must cease PBS-subsidised sitaxentan sodium therapy.   7. Re-treatment with sitaxentan sodium.   Patients who do not respond to treatment are not eligible to receive further PBS-subsidised treatment with sitaxentan sodium under any circumstances.   8. Further information.   A tabulated representation of the above information and the restriction can be obtained from the Medicare Australia website at www.medicareaustralia.gov.au.
0635	TREATMENT OF ADULT PATIENTS WITH SEVERE REFRACTORY CROHN DISEASE   The following information applies to the prescribing under the Pharmaceutical Benefits Scheme (PBS) of adalimumab and infliximab for adult patients with 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 1 time.   From 1 August 2008, 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 August 2008 is considered to be in their first cycle as of 1 August 2008.   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 2008.   (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 2008, 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 without having to requalify with respect to the indices of disease severity (i.e. Crohn Disease Activity Index (CDAI) Score, evidence of intestinal inflammation), or the prior corticosteroid therapy and immunosuppressive therapy.   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 of the CDAI or evidence of intestinal inflammation 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.   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 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 adalimumab or infliximab.    A patient who commenced treatment with adalimumab for severe refractory Crohn disease prior to 9 November 2007 or infliximab prior to 7 March 2007 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.
0636	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:  Chronic myeloid leukaemia (chronic phase);  Dermatofibrosarcoma protuberans;  Hypereosinophilic syndrome;  Chronic eosinophilic leukaemia;  Myelodysplastic or myeloproliferative disorder;  Aggressive systemic mastocytosis with eosinophilia.
0637	A brand premium of $8.03 applies to Desferal 500 mg brand. Both brands may not be available in all hospitals.
0638	A brand premium of $0.39 applies to Desferal 2 g brand. Both brands may not be available in all hospitals.
0639	A brand premium of $0.97 applies to Neoral 25 brand. Both brands may not be available in all hospitals.
0640	A brand premium of $1.05 applies to Neoral 50 brand.  Both brands may not be available in all hospitals.
0641	A brand premium of $1.06 applies to Neoral 100 brand.  Both brands may not be available in all hospitals.
0642	This product may be interchanged with products with "a" flagging in item 1394J.
0643	The products with "a" flagging may also be interchanged with item 1393H.
0644	This product may be interchanged with the products in item 2774B.
0645	These products may also be interchanged with item 2772X.
0646	This product may be interchanged with the products in item 2775C.
0647	These products may also be interchanged with item 2773Y.
0648	Bioequivalence has been demonstrated between paroxetine tablet 20 mg (as hydrochloride) and paroxetine tablet 20 mg (as mesilate).
0649	Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.
0651	Definitions of response.  A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.  A bone marrow or 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.   Authority approval requirements.  For the purposes of assessing response to PBS-subsidised treatment with dasatinib, 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 as follows:  (i) between 10 and 18 months of the commencement of treatment with dasatinib, 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.  For each authority application where eligibility for continuing PBS-subsidised treatment is to be demonstrated, a copy of the cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or a copy of the quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be submitted as described in (i) and (ii) above. For bone marrow analyses, where the standard karyotyping conducted at the time of application is not informative, a copy of a cytogenetic analysis conducted on the bone marrow using FISH with BCR-ABL specific probe must be submitted with the authority application. A copy of the non-informative standard karyotype analysis must be included with the authority application.  Where a patient has previously received PBS-subsidised treatment with dasatinib, no approval will be granted for PBS-subsidised re-treatment where that patient has at any time failed to meet the criteria for continuing treatment.
0652	Dasatinib will only be subsidised for patients with chronic myeloid leukaemia who are not receiving concomitant PBS-subsidised imatinib mesylate, nilotinib or interferon alfa therapy.   Patients should be commenced on a dose of dasatinib of at least 100 mg (base) daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to dasatinib therapy or a peripheral blood BCR-ABL level of less than 1% at 18 months and thereafter at 12 monthly intervals, irrespective of the daily dasatinib dose received.   From 1 November 2008, under the PBS, a patient will be able to trial either dasatinib and/or nilotinib within the initial 18 month treatment period, providing the patient's CML is not resistant to the first second-line agent.   Dasatinib is not PBS-subsidised for patients with CML that is resistant to nilotinib.
0653	Definitions of response.  A major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.  A bone marrow or 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.   Authority approval requirements.  For the purposes of assessing response to PBS-subsidised treatment with 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 as follows:  (i) between 10 and 18 months of the commencement of treatment with nilotinib, 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.   For each authority application where eligibility for continuing PBS-subsidised treatment is to be demonstrated, a copy of the cytogenetic analysis indicating the number of Philadelphia positive [t (9;22)] cells in the bone marrow measured by standard karyotyping, or a copy of the quantitative PCR indicating the relative level of BCR-ABL transcript in the peripheral blood using the international scale, must be submitted as described in (i) and (ii) above. For bone marrow analyses, where the standard karyotyping conducted at the time of application is not informative, a copy of a cytogenetic analysis conducted on the bone marrow using FISH with BCR-ABL specific probe must be submitted with the authority application. A copy of the non-informative standard karyotype analysis must be included with the authority application.  Where a patient has previously received PBS-subsidised treatment with nilotinib, no approval will be granted for PBS-subsidised re-treatment where that patient has at any time failed to meet the criteria for continuing treatment.
0654	Nilotinib will only be subsidised for patients with chronic myeloid leukaemia who are not receiving concomitant PBS-subsidised imatinib mesylate, dasatinib or interferon alfa therapy.   Patients should be commenced on a dose of nilotinib of 400 mg twice daily. Continuing therapy is dependent on patients demonstrating a major cytogenetic response to nilotinib therapy or a peripheral blood BCR-ABL level of less than 1% at 18 months and thereafter at 12 monthly intervals, irrespective of the daily nilotinib dose received.   Nilotinib is not PBS-subsidised for patients with CML that is resistant to dasatinib.  Nilotinib is not TGA-registered and not PBS-subsidised for patients with CML in blast crisis.  Requests for doses of greater than nilotinib 400 mg twice daily will not be approved.   From 1 November 2008, under the PBS, a patient will be able to trial either dasatinib and/or nilotinib within the initial 18 month treatment period, providing the patient's CML is not resistant to the first second-line agent.
0655	The solution for I.V. injection and powder for I.V. injection (after reconstitution) are bioequivalent.
0656	Only 2 courses of PBS-subsidised nicotine replacement therapy will be authorised per year.  No applications for increased maximum quantities and/or repeats will be authorised.  Benefit is improved if used in conjunction with a comprehensive support and counselling program.
0657	Anti-resorptive agents in established osteoporosis include alendronate sodium, risedronate sodium, disodium etidronate, raloxifene hydrochloride, strontium ranelate and zoledronic acid.
0658	The shelf life of Optive is 6 months from the date of opening.
0659	The carcinoma can be considered inoperable for technical or organ preservation reasons.
0660	Sorafenib is not PBS-subsidised for adjunctive treatment after resection, ablation or chemoembolization.  Sorafenib is not PBS-subsidised for maintenance therapy after disease progression.   No applications for increased maximum quantities and/or repeats will be authorised.
0661	Not to be used in preference to enuresis alarms.  Desmopressin nasal spray may be associated with an increased risk of hyponatraemia compared to the tablet formulation.
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
