{"id":"F2005L03805","name":"National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - Special Authority Program (No. PB 37 of 2005)","slug":"f2005l03805","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":356530,"registerId":"commonwealth-F2005L03805-current","compilationNumber":null,"startDate":"2026-04-09","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - Special Authority Program (No. PB 37 of 2005)","content":"COMMONWEALTH OF AUSTRALIA\n\nNational Health Act 1953\n\nARRANGEMENTS MADE UNDER SUBPARAGRAPH 100(1)(b)(i)\n\nSPECIAL AUTHORITY PROGRAM\n\nNo. PB 37 of 2005\n\nI, JOAN CORBETT, Assistant Secretary, Pharmaceutical Benefits Branch, Department of Health and Ageing and delegate of the Minister for Health and Ageing, pursuant to subparagraph 100(1)(b)(i) of the National Health Act 1953, hereby make the following Arrangements for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who require treatment with imatinib mesylate, being a drug or medicinal preparation declared under subsection 85(2) of the National Health Act 1953:\n\nCommencement\n\n1. (a) These Arrangements commence on 1 December 2005.\n\n(b) The Arrangements made on 26 July 2005 with effect from 1 August 2005\n\n(No. PB 23 of 2005) are repealed with effect from the commencement of these Arrangements.\n\nDefinitions\n\n2. In these Arrangements:\n\n(a) unless the contrary intention appears, a word or phrase will be taken to have the same meaning as in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations;\n\n(b) “Act” means the National Health Act 1953;\n\n(c) “approved supplier” includes a public hospital that is not participating in the arrangements set out in Appendix F to the Australian Health Care Agreements but is approved by the Medicare Australia CEO to issue safety net concession cards and pharmaceutical benefits entitlement cards;\n\n(d) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia ;\n\n(e) “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.\n\n3. Except where otherwise specified in these Arrangements, the provisions of the Act, the Regulations and the declarations, determinations and other instruments made under Part VII of the Act and under the Regulations will apply to the prescribing and supply of imatinib mesylate.\n\n  \nEntitlement to receive imatinib mesylate under these Arrangements\n\n4. Subject to these Arrangements, a person who:\n\n(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and\n\n(b) is receiving medical treatment by a medical practitioner;\n\nis entitled to receive imatinib mesylate under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraph 17.\n\nPrescriptions for imatinib mesylate\n\n5. The writing of a prescription for the supply of imatinib mesylate as a special pharmaceutical product under these Arrangements is authorised only in the circumstances specified in Schedule 1 or Schedule 2.\n\n6. These Arrangements apply to imatinib mesylate for oral administration in the following forms and marketed under the following brands:\n\nForm (strength, type, size, etc.) Proprietary name Manufacturer\n\nTablet 100 mg (base) (pack of 60) Glivec Novartis Pharmaceuticals Australia Pty Ltd\n\nTablet 400 mg (base) (pack of 30) Glivec Novartis Pharmaceuticals Australia Pty Ltd\n\n7. Subject to paragraph 12, the maximum quantity that may be prescribed on a prescription for imatinib mesylate is:\n\n(a) in respect of the tablet 100 mg, 3 packs of 60 tablets (unless the prescription is for the first 3 months of treatment of a previously untreated patient with a metastatic or unresectable malignant gastrointestinal stromal tumour, in which case the maximum quantity that may be prescribed is 2 packs);\n\n(b) in respect of the tablet 400 mg, 1 pack of 30 tablets.\n\n8. Subject to paragraph 13, the maximum number of repeats that may be prescribed on a prescription for imatinib mesylate is:\n\n(a) 5, in the case of a prescription for the treatment of the chronic phase of chronic myeloid leukaemia; or\n\n(b) 2, in the case of a prescription for the treatment of the accelerated phase of chronic myeloid leukaemia or the blast phase of chronic myeloid leukaemia; or\n\n(c) 2, in the case of a prescription for the treatment of a metastatic or unresectable malignant gastrointestinal stromal tumour.\n\n9. (1) Subject to subparagraph (2), a medical practitioner who wishes to prescribe imatinib mesylate under these Arrangements must:\n\n(a) prepare and sign a prescription for imatinib mesylate:\n\n  \n\n(i) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or\n\n(ii) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubparagraph (i); or\n\n(iii) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or\n\n(iv) by a method approved in writing by the Secretary; and\n\n(b) submit the prescription and, where appropriate, the material specified in Schedule 1 or Schedule 2:\n\n(i) by sending it to the following address:\n\nMedicare Australia\n\nPrior Written Approval of Specialised Drugs\n\nReply Paid 9826\n\nGPO Box 9826\n\nHobart Tasmania 7001; or\n\n(ii) in the case of continuing treatment for a metastatic or unresectable malignant gastrointestinal stromal tumour, or continuing treatment for the accelerated phase of chronic myeloid leukaemia or the blast phase of chronic myeloid leukaemia, submit the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subparagraph (1)(a);\n\n(2) Where the appropriate Imatinib Mesylate (Glivec) PBS Authority Application – Supporting Information Form approved by the Medicare Australia CEO is completed by the medical practitioner, it will not be necessary for the medical practitioner to complete the triplicate copy of the prescription referred to in subparagraph 1(a).\n\nAuthorisation of prescriptions for imatinib mesylate\n\n10. The authorisation of a prescription submitted under paragraph 9 may be made:\n\n(a) if the prescription was submitted in accordance with subparagraph 9(1)(a) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:\n\n  \n\n(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or\n\n(ii) in any other case:\n\n(A) by returning it to the medical practitioner; or\n\n(B) by sending it to the person in respect of whom it was prepared; or\n\n(b) if the prescription was submitted in accordance with subsubparagraph 9(1)(b)(ii) — verbally, at the time the Medicare Australia CEO is given details of the prescription.\n\n11. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 10(b):\n\n(a) the Medicare Australia CEO must tell the medical practitioner the number that has been allotted to the authorised prescription; and\n\n(b) the medical practitioner must:\n\n(i) mark that number on the prescription; and\n\n(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.\n\n12. Regulation 13 of the Regulations applies to the prescribing of imatinib mesylate only to the extent that:\n\n(a) in respect of the tablet 100 mg, the Medicare Australia CEO may authorise a quantity of 4 of the pack of 60 tablets for the treatment of patients in the accelerated phase or the blast phase of chronic myeloid leukaemia;\n\n(b) in respect of the tablet 400 mg, the Medicare Australia CEO may authorise a quantity of 2 of the pack of 30 tablets for the treatment of patients in the accelerated phase or the blast phase of chronic myeloid leukaemia.\n\n13. The Medicare Australia CEO must not authorise the supply of imatinib mesylate tablets to be repeated in respect of a prescription for a foreign person who is entitled to be treated as an eligible person within the meaning of the Health Insurance Act 1973 under section 7 of that Act.\n\n14. Regulation 24 of the Regulations applies to the supply of imatinib mesylate as if the quantity or number of units of imatinib mesylate tablets authorised by the Medicare Australia CEO under paragraph 10 or 11 were the maximum quantity or number of units applicable in relation to a pharmaceutical benefit in accordance with a determination of the Minister under paragraph 85A(2)(a) of the Act.\n\n  \n\n15. Regulation 25 of the Regulations applies to the supply of imatinib mesylate as if it were a pharmaceutical benefit in relation to which the Minister has determined, under paragraph 85A(2)(b) of the Act, that the maximum number of occasions on which the supply of the benefit may, in one prescription, be directed to be repeated is more than 4.\n\nSupplier of imatinib mesylate under these Arrangements\n\n16. Imatinib mesylate may be supplied:\n\n(a) by an approved pharmacist; or\n\n(b) by an approved medical practitioner; or\n\n(c) by an approved hospital authority, to a patient receiving treatment at the hospital of which it is the governing body or proprietor; or\n\n(d) by a public hospital that is not participating in the arrangements set out in Appendix F to the Australian Health Care Agreements but is approved by the Medicare Australia CEO to issue safety net concession cards and pharmaceutical benefits entitlement cards.\n\nCost to patient of imatinib mesylate under these Arrangements\n\n17. An approved supplier that supplies imatinib mesylate may charge the person to whom the drug is supplied an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the person.\n\nPayment to supplier of imatinib mesylate under these Arrangements\n\n18. An approved supplier that has supplied imatinib mesylate is entitled to be paid by the Commonwealth as if paragraphs 20 to 23 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in PB No. 35 of 2005 applies to imatinib mesylate.\n\nDated this twenty third day of November 2005.\n\nJOAN CORBETT\n\nAssistant Secretary\n\nPharmaceutical Benefits Branch\n\nDepartment of Health and Ageing\n\nDelegate of the Minister for Health and Ageing\n\nInitial treatment for adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour\n\nInitial treatment subsidised under the Pharmaceutical Benefits Scheme (PBS), for up to 3 months, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour which has been histologically confirmed by the detection of CD117 on immunohistochemical staining.\n\nPatients who have not previously been treated with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour must commence treatment at a dose not exceeding 400 mg per day for at least 3 months. Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.\n\nPatients who have previously been treated with non-PBS-subsidised imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour are eligible to receive up to 3 months treatment at a dose of up to 600 mg per day.\n\nAuthorisation process of prescriptions for imatinib mesylate for initial treatment of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour\n\nApplications for authorisation must be in writing and must include:  \n(1) a completed authority prescription form; and  \n(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Gastrointestinal Stromal Tumour - Supporting Information Form which includes the following:  \n(i) a copy of a pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining; and\n\n(ii) a copy of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease; and\n\n(iii) where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence in support of that claim; and\n\n(iv) for patients who commenced treatment with imatinib mesylate for a metastatic or unresectable malignant gastrointestinal stromal tumour prior to 1 December 2004, the date on which therapy with imatinib mesylate was commenced.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nContinuing treatment for adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour\n\nContinuing treatment, at a dose of up to 600 mg per day, of adult patients with a metastatic or unresectable malignant gastrointestinal stromal tumour who have previously been issued with an authority prescription for this drug.\n\nInitial treatment of patients in the chronic phase of chronic myeloid leukaemia\n\nInitial treatment of patients in the chronic phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia.\n\nApplications under this restriction will be limited to provide patients with a maximum of 18 months of therapy from the date the first application for initial treatment was approved.\n\nAuthorisation process of prescriptions for imatinib mesylate for intial treatment of patients in the chronic phase of chronic myeloid leukaemia\n\nApplications for authorisation must be in writing and must include:\n\n(1) a completed authority prescription form; and\n\n(2) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia – Supporting Information form; and\n\n(3) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of chronic myeloid leukaemia to confirm eligibility for treatment, or a qualitative polymerase chain reaction (PCR) report documenting the presence of the bcr-abl transcript in either peripheral blood or bone marrow; and\n\n(4) a copy of a signed patient acknowledgement form indicating that the patient understands and acknowledges that PBS-subsidised treatment with imatinib mesylate for the chronic phase of chronic myeloid leukaemia will cease if subsequent testing demonstrates that:\n\n(i) the patient has failed to achieve a major cytogenetic response within the initial 18 months of treatment \\[see Note defining major cytogenetic response\\]; or\n\n(ii) the patient has failed to sustain a major cytogenetic response for 12 months from the date of the last pathology report that indicated that a major cytogenetic response had been achieved \\[see Note defining major cytogenetic response\\].\n\nNOTE:\n\nImatinib 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.\n\nPatients 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.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\n  \n\nContinuing treatment of patients in the chronic phase of chronic myeloid leukaemia\n\nContinuing treatment of patients who have received initial treatment with imatinib mesylate as a special pharmaceutical product for the chronic phase of chronic myeloid leukaemia and who have demonstrated a major cytogenetic response in the preceding 12 months.\n\nAuthorisation process of prescriptions for imatinib mesylate for continuing treatment of patients in the chronic phase of chronic myeloid leukaemia\n\nApplications for authorisation must be in writing and must include:\n\n(1) a completed authority prescription form; and\n\n(2) demonstration of continued response to treatment as evidenced by major cytogenetic response \\[see Note explaining requirements\\]. Where this has been supplied within the previous 12 months, only the date of the relevant pathology report need be provided.\n\nNOTE:\n\nDefinition of response.\n\nA major cytogenetic response is defined as less than 35% Philadelphia positive bone marrow cells.\n\nAuthority approval requirements.\n\nFor the purposes of assessing response to PBS-subsidised treatment with imatinib mesylate, cytogenetic analysis indicating the number of Philadelphia positive \\[t (9;22)\\] cells in the bone marrow measured by standard karyotyping must be submitted. 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 or quantitative PCR must be submitted. The cytogenetic analyses must be submitted as follows:\n\n(i) between 10 and 12 months of the commencement of treatment with imatinib mesylate, at which time patients in whom a major cytogenetic response has been demonstrated may receive authorisation for a further 12 months of treatment; and\n\n(ii) within 18 months of the commencement of treatment with imatinib mesylate, in patients who have failed to demonstrate a major cytogenetic response at between 10 and 12 months (patients in whom a major cytogenetic response is demonstrable by 18 months may also receive authorisation for a further 12 months of treatment); and\n\n(iii) at no greater than 12 month intervals thereafter, to demonstrate that the major cytogenetic response has been sustained.\n\nFor 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 must be submitted as described in (i) to (iii) above, unless, at the time of the authority application, the standard karyotyping is not informative. 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 either FISH with bcr-abl specific probe or quantitative PCR must be submitted with the authority application. For patients in whom cytogenetic status is determined on the basis of bcr-abl transcript level measured by quantitative PCR performed on the bone marrow, continuation of treatment will be authorised irrespective of changes to bcr-abl transcript levels. A copy of the non-informative standard karyotype analysis must be included with the authority application.\n\nFor patients in whom failure to obtain a bone marrow sample (dry tap) has occurred on 2 separate consecutive occasions at any point described in (i) to (iii) above and at no greater than 2 months between each attempt, results of a quantitative PCR analysis of peripheral blood providing bcr-abl transcript levels will be accepted as the basis for continuing therapy thereafter. The first application for continuing treatment for patients in whom there has been a failure to obtain bone marrow samples on 2 separate consecutive occasions, must include 2 pathology reports demonstrating failure to obtain an adequate bone marrow sample. In cases where pathology reports are not obtainable, a statement from the treating specialist that no bone marrow sample could be obtained from 2 separate attempts will be accepted. A pathology report from an Approved Pathology Authority providing the results of the quantitative PCR analysis of peripheral blood must also be submitted and must clearly state the level of bcr-abl transcript which reliably corresponds to less than 35% Philadelphia positive bone marrow cells.\n\nWhere 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.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\n  \nInitial treatment of patients in the accelerated phase of chronic myeloid leukaemia\n\nTreatment of patients in the accelerated phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia. Progress to the accelerated phase is defined by the presence of 1 or more of the following:\n\n(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or\n\n(2) Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%; or\n\n(3) Peripheral basophils greater than or equal to 20%; or\n\n(4) Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or\n\n(5) Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).\n\nAuthorisation process of prescriptions for imatinib mesylate for initial treatment of patients in the accelerated phase of chronic myeloid leukaemia\n\nApplications for authorisation must be in writing and must include:\n\n(a) a completed authority prescription form; and\n\n(b) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and\n\n(c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criteria (1), (2), (3) and (5) above, or details of the dates of assessments in the case of progressive splenomegaly.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nInitial treatment of patients in the blast phase of chronic myeloid leukaemia\n\nTreatment of patients in the blast phase of chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, and who have a primary diagnosis of chronic myeloid leukaemia. Progress to myeloid blast crisis is defined as either:\n\n(1) Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or\n\n(2) Extramedullary involvement other than spleen and liver.\n\n  \nAuthorisation process of prescriptions for imatinib mesylate for initial treatment of patients in the blast phase of chronic myeloid leukaemia\n\nApplications for authorisation must be in writing and must include:\n\n(a) a completed authority prescription form; and\n\n(b) a completed Imatinib Mesylate (Glivec) PBS Authority Application for Use in the Treatment of Chronic Myeloid Leukaemia - Supporting Information form, stating which of the above criteria are satisfied by the patient; and\n\n(c) a copy of the confirming pathology report from an Approved Pathology Authority in the case of criterion (1) above, or details of the date of assessment in the case of extramedullary involvement.\n\n\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nContinuing treatment of patients in the accelerated or blast phase of chronic myeloid leukaemia\n\nContinuing treatment of patients with chronic myeloid leukaemia expressing the Philadelphia chromosome or the transcript, bcr-abl tyrosine kinase, where the patient has previously received PBS-subsidised treatment with imatinib mesylate of:\n\n(i) the accelerated phase of chronic myeloid leukaemia; or\n\n(ii) the blast phase of chronic myeloid leukaemia.","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[{"type":"impossible_compliance","section":"Paragraph 7(a)","severity":"high","reasoning":"Schedule 1 mandates that previously untreated GIST patients must commence at a dose not exceeding 400mg/day for at least 3 months. At 400mg/day using 100mg tablets, a patient requires 4 tablets per day, meaning 2 packs of 60 provides only 30 days of treatment. However, paragraph 7(a) caps the initial 3-month prescription at 2 packs. The arrangement thus simultaneously mandates 3 months of treatment while capping supply at 1 month's worth of tablets at the required dose. The 400mg tablet (paragraph 7(b)) allows 1 pack of 30 tablets = 30 days supply, which has the same problem. There is no mathematical combination of the two tablet forms under these caps that achieves the mandated 3 months of treatment on a single prescription.","confidence":0.82,"description":"The maximum quantity for the 100mg tablet is 3 packs of 60, but for the first 3 months of treatment of a previously untreated GIST patient it drops to 2 packs. At 400mg/day (the mandated starting dose), 2 packs of 60 x 100mg tablets provides only 30 days of supply, yet the initial treatment period is explicitly 3 months. The quantity cap actively prevents a full month's supply at the prescribed dose, let alone 3 months."},{"type":"other","section":"Paragraph 9(2) cross-referencing subparagraph 1(a)","severity":"medium","reasoning":"The cross-reference to 'subparagraph 1(a)' in paragraph 9(2) appears to be a drafting error — paragraph 1(a) sets the commencement date of the Arrangements. A triplicate prescription form is not mentioned anywhere in paragraph 1. The intended reference is almost certainly to subparagraph 9(1)(a), which describes the handwritten or computer-generated prescription form. This broken cross-reference creates genuine ambiguity about when the Supporting Information Form can substitute for the triplicate copy.","confidence":0.88,"description":"Paragraph 9(2) refers to 'the triplicate copy of the prescription referred to in subparagraph 1(a)', but subparagraph 1 deals with commencement and repeal dates — not prescription forms. The triplicate copy is dealt with in subparagraph 9(1)(a). The internal cross-reference is broken."},{"type":"other","section":"Schedule 1 — Initial GIST treatment (dose cap vs. continuing treatment entitlement)","severity":"low","reasoning":"While there may be a clinical rationale (prior non-PBS patients may have already demonstrated a need for higher doses), the arrangement creates a perverse incentive: a patient who can afford to buy imatinib privately first is immediately entitled to 600mg/day under PBS, while a patient who could not afford private treatment is locked to 400mg/day for 3 months with no authority exception. This is an inequality baked into the instrument itself, though not strictly logically impossible to comply with.","confidence":0.72,"description":"Previously untreated GIST patients are capped at 400mg/day for the initial 3 months with no authority for a higher dose. However, patients who have previously been treated with non-PBS imatinib for GIST are immediately eligible for up to 600mg/day. This creates an absurd incentive structure where patients who obtained the drug privately before listing are given more generous dosing than treatment-naive PBS patients, despite the clinical rationale (dose escalation) applying equally to both groups."},{"type":"impossible_compliance","section":"Paragraph 10(a) — authorisation by the Medicare Australia CEO signing 'his or her' authorisation","severity":"medium","reasoning":"The provision is drafted in strictly personal terms ('the Medicare Australia CEO signing his or her authorisation'). There is no delegation provision within these Arrangements themselves permitting a delegate to sign on the CEO's behalf for this specific act (though delegation powers may exist elsewhere in parent legislation). If read literally, every single written authority prescription for imatinib mesylate across Australia requires the CEO's personal wet signature, which is operationally impossible.","confidence":0.65,"description":"Paragraph 10(a) requires the Medicare Australia CEO to personally sign his or her authorisation on every written prescription. Given the volume of PBS authority prescriptions nationally, it is physically impossible for a single individual (the CEO) to personally sign every prescription."},{"type":"other","section":"Paragraph 18","severity":"medium","reasoning":"The payment provisions for suppliers are entirely dependent on an external instrument (PB 35 of 2005) remaining in force and unchanged. These Arrangements contain no savings clause or fallback. Repeal or amendment of PB 35 of 2005 would directly undermine the enforceability of the payment entitlement under paragraph 18, leaving approved suppliers without a clear legal basis for Commonwealth reimbursement.","confidence":0.78,"description":"The payment entitlement for suppliers is determined by incorporating by reference 'paragraphs 20 to 23 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in PB No. 35 of 2005'. This creates an ambulatory incorporation by reference: if PB No. 35 of 2005 is amended or repealed, the payment regime for imatinib mesylate under this instrument becomes uncertain or void without any amendment to this instrument."},{"type":"other","section":"Schedule 1 — Continuing treatment for GIST (no upper time limit or response criteria)","severity":"low","reasoning":"In stark contrast to the CML continuing treatment provisions (which require demonstrated major cytogenetic response, 12-monthly cytogenetic analyses, and explicit cessation criteria), the continuing GIST treatment restriction contains no requirement to demonstrate tumour response, stable disease, or any other clinical outcome. A patient could theoretically continue receiving subsidised imatinib indefinitely regardless of clinical benefit, simply by having previously received an authority prescription.","confidence":0.8,"description":"The initial GIST treatment is strictly limited to 3 months with detailed documentation requirements, but the continuing GIST treatment section imposes no maximum duration and no response criteria whatsoever — it merely requires that the patient 'has previously been issued with an authority prescription for this drug'. There are no clinical benchmarks for cessation, creating a potentially indefinite entitlement with no therapeutic accountability."},{"type":"other","section":"Schedule 1 — Continuing treatment (CML chronic phase): re-treatment prohibition","severity":"medium","reasoning":"A permanent lifetime ban on re-treatment based on a single historical failure to meet continuing treatment criteria is clinically extreme. It makes no allowance for: (a) errors in prior pathology reports, (b) patients who progressed to accelerated or blast phase and then returned to chronic phase, (c) patients who ceased treatment for non-response reasons unrelated to cytogenetic criteria. While this may be deliberate policy, the absolute drafting creates situations where re-treatment that would plainly be appropriate is forbidden by the literal terms of the Arrangements.","confidence":0.75,"description":"The re-treatment prohibition states that '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.' The phrase 'at any time' creates a permanent and irrevocable bar, even if subsequent clinical developments (e.g. new cytogenetic data, laboratory error in original testing, or disease re-staging) would justify re-treatment. The absolute prohibition admits no exceptions."}],"contradictions":[{"severity":"high","section_a":"Paragraph 7(a) — maximum quantity for initial GIST (2 packs of 60 x 100mg)","section_b":"Schedule 1 — Initial GIST treatment (mandating at least 3 months at 400mg/day)","confidence":0.82,"description":"Paragraph 7(a) caps the initial 3-month GIST prescription at 2 packs of 60 x 100mg tablets (= 120 tablets = 30 days at 400mg/day using 100mg tablets). Schedule 1 simultaneously mandates that previously untreated patients must be treated at a dose not exceeding 400mg/day 'for at least 3 months'. The quantity cap is mathematically inconsistent with the minimum treatment duration at the required dose."},{"severity":"medium","section_a":"Paragraph 8(a) — 5 repeats for chronic phase CML","section_b":"Paragraph 15 — application of Regulation 25 as if Minister determined more than 4 repeats permissible","confidence":0.68,"description":"Paragraph 8(a) directly specifies 5 repeats for chronic phase CML prescriptions. Paragraph 15 applies Regulation 25 of the Regulations 'as if' the Minister had determined under paragraph 85A(2)(b) that the maximum repeats is 'more than 4'. These two provisions are consistent in outcome (both permit 5 repeats) but paragraph 15 is legally redundant if paragraph 8(a) already sets the maximum at 5, and the 'as if' fiction in paragraph 15 could be read as permitting any number greater than 4, not just 5, creating ambiguity about whether the hard cap in paragraph 8 or the open-ended 'more than 4' threshold in paragraph 15 prevails."},{"severity":"low","section_a":"Paragraph 5 — prescribing authorised only in circumstances in Schedule 1 or Schedule 2","section_b":"Paragraph 3 — general provisions of the Act and Regulations apply except where otherwise specified","confidence":0.6,"description":"Paragraph 3 provides that the general regulatory framework applies 'except where otherwise specified in these Arrangements', implying a general permission subject to carve-outs. Paragraph 5 then states prescribing is 'authorised only' in the circumstances in Schedule 1 or 2, which is an exhaustive and exclusive code. If the Act or Regulations create any additional prescribing authorisations for imatinib, paragraph 3 would preserve them while paragraph 5 would exclude them. The tension between 'except where otherwise specified' (paragraph 3, preserving the general law) and 'authorised only' (paragraph 5, exclusive code) creates potential conflict as to whether any non-Schedule prescription pathway could exist."},{"severity":"medium","section_a":"Paragraph 9(1)(b)(ii) — telephone submission for continuing CML accelerated/blast phase treatment","section_b":"Schedule 1 — Accelerated and blast phase initial treatment requiring written applications with pathology reports","confidence":0.65,"description":"Paragraph 9(1)(b)(ii) permits telephone submission for 'continuing treatment for the accelerated phase of chronic myeloid leukaemia or the blast phase of chronic myeloid leukaemia'. However, Schedule 1 specifies that applications for initial treatment of accelerated and blast phase CML must be in writing and include pathology reports and completed forms. There is no explicit pathway in paragraph 9 for a written submission for initial CML accelerated/blast phase treatment that is separate from the GIST written submission pathway under 9(1)(b)(i). Read strictly, paragraph 9(1)(b)(i) (postal submission) appears to apply only to initial GIST treatment, leaving initial accelerated/blast phase CML applications without a clearly specified written submission mechanism distinct from the telephone pathway reserved for continuing treatment."},{"severity":"low","section_a":"Paragraph 13 — no repeats for foreign persons eligible under section 7 of the Health Insurance Act 1973","section_b":"Paragraph 4 — entitlement for all persons treated as eligible persons within the meaning of the Health Insurance Act 1973","confidence":0.73,"description":"Paragraph 4 grants entitlement to receive imatinib to any person who 'is, or is to be treated as, an eligible person' under the HIA 1973, which on its face includes foreign persons eligible under section 7 of that Act. Paragraph 13 then prohibits the CEO from authorising repeats for precisely that subset of persons. The result is that foreign persons are granted an entitlement under paragraph 4 that is immediately curtailed by paragraph 13 to a single, non-repeatable supply — but paragraph 4 contains no cross-reference warning of this limitation, creating a misleading grant of entitlement."}]},"summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"This instrument is tightly focused on a single purpose from the outset: regulating subsidised access to imatinib mesylate (Glivec) for two specific cancer indications under the PBS Special Authority framework. It replaces an earlier version of the same arrangement (PB 23 of 2005) and represents an update — not an expansion — of the scheme. The scope has not drifted beyond its original intent. The complexity arises from the clinical intricacy of the conditions being treated, not from legislative scope creep."},"complexity_factors":["Multiple cross-references to external instruments — the National Health Act 1953, the National Health (Pharmaceutical Benefits) Regulations 1960, PB No. 35 of 2005, the Health Insurance Act 1973, and the Australian Health Care Agreements","Highly technical clinical criteria embedded in the Schedules, including specific laboratory test types (cytogenetics, FISH, quantitative PCR, immunohistochemistry) and percentage thresholds for disease staging","Tiered conditional logic: different rules apply depending on (a) the disease being treated, (b) whether it is initial or continuing treatment, and (c) the phase of disease (chronic/accelerated/blast)","Nested exceptions on prescription quantities — e.g. maximum quantities differ per tablet strength, per disease phase, and with a carve-out for the first 3 months of GIST treatment","Dual authorisation pathways — written submission vs. telephone approval — with different procedural requirements for each","Multiple defined terms that inherit meaning from parent legislation unless otherwise specified, creating interpretive dependency on instruments not reproduced here","Strict ongoing eligibility conditions for CML continuing treatment, with timed review windows (10–12 months, 18 months, then 12-month intervals), creating a complex compliance calendar","Special rules for 'dry tap' bone marrow failure scenarios — an unusual edge-case provision requiring 2 separate failed attempts before alternative testing is accepted","Restriction on re-treatment after loss of response in chronic phase CML — a permanent exclusion condition embedded in Schedule notes","Foreign person restriction in paragraph 13 modifying the repeat supply rules"],"plain_english_summary":"This instrument creates a Special Authority Program to subsidise imatinib (Glivec) on the PBS for eligible Medicare patients with CML or unresectable/metastatic GIST. It affects patients, prescribers and authorised dispensers by requiring prior approval and specified clinical evidence, strict quantity/repeat limits and ongoing response monitoring. The scheme makes this costly, life‑changing therapy affordable while tightly controlling who receives continued subsidised treatment."}},"importantCases":[],"_links":{"self":"/api/acts/f2005l03805","history":"/api/acts/f2005l03805/history","analysis":"/api/acts/f2005l03805/analysis","conflicts":"/api/acts/f2005l03805/conflicts","importantCases":"/api/acts/f2005l03805/important-cases","documents":"/api/acts/f2005l03805/documents"}}