{"id":"F2005L03741","name":"National Health Act 1953 - Arrangements made under subparagraph 100(1)(b)(i) - Highly Specialised Drugs Program (No. PB 35 of 2005)","slug":"f2005l03741","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":356523,"registerId":"commonwealth-F2005L03741-current","compilationNumber":null,"startDate":"2026-04-09","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Commencement","sectionType":"part","heading":"Commencement","content":"## Commencement\n\n1.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on 1 December 2005.\n\n(b) The Arrangements made on 26 July 2005 with effect from 1 August 2005 (No. PB 21 of 2005) are repealed with effect from the commencement of these Arrangements.","sortOrder":0},{"sectionNumber":"Definitions","sectionType":"part","heading":"Definitions","content":"## Definitions\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) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;\n\n(d) “details of the prescription”, for the purpose of subparagraph 11(b), means:\n\n(i) all matters included in the prescription completed by the medical practitioner in accordance with subparagraph 11(a); and\n\n(ii) the proposed duration of treatment for which authority is sought by the medical practitioner; and\n\n(iii) the provider number of the hospital with which the medical practitioner is affiliated;\n\n \n\n(e) “highly specialised drug” means a special pharmaceutical product in relation to which, by virtue of paragraphs 4, 7 and 9, these Arrangements apply;\n\n(f) “medical practitioner” means a medical practitioner, within the meaning of the Health Insurance Act 1973, who is affiliated with the hospital in or at which the patient is receiving treatment and is:\n\n(i) a staff hospital specialist; or\n\n(ii) a visiting or consulting specialist of the hospital; or\n\n(iii) providing maintenance therapy in a situation where it is impractical to obtain a prescription from, and with the agreement of, a medical practitioner referred to in subsubparagraph (i) or (ii); or\n\n(iv) accredited, in the State or Territory in which the medical practitioner practises, to prescribe medication for the treatment of HIV or AIDS; or\n\n(v) the subject of a specific arrangement between the Commonwealth and the relevant State or Territory Government;\n\n(g) “medication for the treatment of HIV or AIDS” means any of the following highly specialised drugs:\n\nabacavir sulfate\n\nabacavir sulfate with lamivudine\n\nabacavir sulfate with lamivudine and zidovudine\n\namprenavir\n\natazanavir sulfate\n\nazithromycin dihydrate\n\ncidofovir\n\nclarithromycin\n\ndelavirdine mesylate\n\ndidanosine\n\ndoxorubicin hydrochloride, pegylated liposomal\n\nefavirenz\n\nemtricitabine\n\nenfuvirtide\n\nfosamprenavir calcium\n\nfoscarnet sodium\n\nganciclovir\n\nganciclovir sodium\n\nindinavir sulfate\n\nlamivudine (tablet 150 mg, tablet 300 mg or oral solution 10 mg per mL, 240 mL)\n\nlamivudine with zidovudine\n\nlopinavir with ritonavir\n\nnelfinavir mesylate\n\nnevirapine\n\nrifabutin\n\nritonavir\n\nsaquinavir\n\nsaquinavir mesylate\n\nstavudine\n\nstavudine with water - purified BP\n\ntenofovir disoproxil fumarate\n\nvalaciclovir hydrochloride\n\nvalganciclovir hydrochloride\n\nzalcitabine\n\nzidovudine\n\n(h) “private hospital” has the same meaning as in subsection 3(1) of the Health Insurance Act 1973;\n\n(i) “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.","sortOrder":1},{"sectionNumber":"Entititlement to receive highly speciali","sectionType":"part","heading":"Entititlement to receive highly specialised drugs under these Arrangements","content":"## Entititlement to receive highly specialised drugs under these Arrangements\n\n3. 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 at a private hospital as a non-admitted patient, day admitted patient or patient on discharge;\n\nis entitled to receive highly specialised drugs under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraphs 19 and 19A.\n\n4. The special pharmaceutical products to which these Arrangements apply are the highly specialised drugs specified in column 1 of Schedule 1.\n\n5. The supply of a highly specialised drug under these Arrangements is authorised only in the circumstances specified in column 2 of Schedule 1 in relation to the highly specialised drug.\n\n6. The following circumstances are specified in relation to each highly specialised drug:\n\n(a) where a class of persons is specified in column 2 of Schedule 1 — the highly specialised drug is to be supplied for the treatment of a person included in that class of persons; or\n\n(b) where a disease or condition is specified in column 2 of Schedule 1 —\n\n(i) if subsubparagraph (ii) does not apply — the highly specialised drug is to be supplied for the treatment of that disease or condition in relation to any person; or\n\n(ii) if the disease or condition is specified in relation to a specified class of persons — the highly specialised drug is to be supplied for the treatment of that disease or condition in a person included in that class of persons; or\n\n(c) where a purpose is specified in column 2 of Schedule 1 — the highly specialised drug is to be supplied for that purpose.\n\n7. Where strength, type of unit, size of unit or other particulars of form are specified in column 2 of Schedule 2 or column 2 of Schedule 3 in relation to a special pharmaceutical product, each specified form of the product is a highly specialised drug, and these Arrangements do not apply in relation to the special pharmaceutical product in any other form.\n\n8. The manner of administration specified in column 3 of Schedule 2 in relation to a highly specialised drug is the only manner of administration that may be directed to be used in relation to the highly specialised drug.\n\n9. The name of the manufacturer or the names of the manufacturers denoted in accordance with the following table by letters specified in column 4 of Schedule 2 in relation to a special pharmaceutical product is or are the brand or brands under which the special pharmaceutical product may be supplied as a highly specialised drug, and these Arrangements do not apply to the special pharmaceutical product as marketed under any other brand:\n\n```html\n

Letters

Manufacturer’s Name

Letters

Manufacturer’s Name

AB

Abbott Australasia Pty Ltd

JC

Janssen-Cilag Pty Ltd

AN

Amgen Australasia Pty Ltd

MK

Merck Sharp & Dohme (Australia) Pty Ltd

AP

AstraZeneca Pty Ltd

MX

Mayne Pharma Pty Ltd

AT

Actelion Pharmaceuticals Australia Pty Ltd

NV

Novartis Pharmaceuticals Australia Pty Ltd

OA

Orphan Australia Pty Ltd

BQ

Bristol-Myers Squibb Pharmaceuticals A Division of Bristol-Myers Squibb Australia Pty Ltd

PF

Pfizer Pty Limited

PU

Pharmacia Products Pharmacia & Upjohn Pty Limited

BU

Bausch & Lomb A Division of Bausch & Lomb (Australia) Pty Ltd

PS

Pharmacia & Upjohn Pty Limited

RO

Roche Products Pty Ltd

BY

Boehringer Ingelheim Pty Limited

SC

Schering Pty Ltd

GI

Gilead Sciences Pty Ltd

SH

Schering-Plough Pty Ltd

GK

GlaxoSmithKline Australia Pty Ltd

WY

ZT

Wyeth Pharmaceuticals Division of Wyeth Australia Pty Limited

Synthon AU Pty Ltd

HX

Hexal Australia Pty Ltd

IS

Ipsen Pty Limited

\n```\n\n10. Where a prescription specifies a quantity of a highly specialised drug listed in Schedule 3 that is less than the quantity contained in the size of unit included in the particulars specified in column 2 of that Schedule in relation to that highly specialised drug, the complete pack shall be supplied.\n\n \n\nPrescriptions for highly specialised drugs\n\n11. A medical practitioner who wishes to prescribe a highly specialised drug must submit to the Medicare Australia CEO a prescription for the supply of the highly specialised drug:\n\n(a) by preparing and signing a prescription for the highly specialised drug:\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; or\n\n(b) subject to paragraph 11AA, by submitting the prescription:\n\n(i) 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 (a); or\n\n(ii) where the medical practitioner has attempted to obtain an authorisation by submitting details of the prescription to the Medicare Australia CEO in accordance with subsubparagraph (i) but has been unable to do so because of a failure or other form of unavailability in the telephone system established by the Medicare Australia CEO for the provision of such authorisations, by submitting the prescription in accordance with the instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.\n\n11AA. A medical practitioner may not submit a prescription to the Medicare Australia CEO in accordance with subparagraph 11(b):\n\n(a) in the case of the highly specialised drugs “etanercept” and “iloprost trometamol”, unless the medical practitioner has previously submitted a prescription to the Medicare Australia CEO in accordance with subparagraph 11(a) for a particular patient and for a specified circumstance, and the number of repeats that was authorised by the Medicare Australia CEO was less than the maximum number of repeats allowable for that purpose. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i) for the balance of the allowable repeats for that patient for that circumstance; or\n\n \n\n(b) in the case of the highly specialised drug “infliximab”:\n\n(i) unless the medical practitioner has previously submitted a prescription to the Medicare Australia CEO in accordance with subparagraph 11(a) for a particular patient and for a specified circumstance and the number of repeats that was authorised by the Medicare Australia CEO was less than the maximum number of repeats allowable for that purpose. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i) for the balance of the allowable repeats for that patient for that circumstance; or\n\n(ii) unless the prescription is the first prescription for continuing PBS-subsidised treatment for an adult patient with active ankylosing spondylitis immediately following a course of therapy initiating, or recommencing, PBS-subsidised treatment with infliximab, and is for a single dose only. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i); or\n\n(c) in the case of the highly specialised drug “bosentan monohydrate”:\n\n(i) unless the medical practitioner has previously submitted a prescription to the Medicare Australia CEO in accordance with subparagraph 11(a) for a particular patient and for a specified circumstance, and the number of repeats that was authorised by the Medicare Australia CEO was less than the maximum number of repeats allowable for that purpose. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i) for the balance of the allowable repeats for that patient for that circumstance; or\n\n(ii) unless the prescription is for the final PBS-subsidised supply for the patient. In such case the medical practitioner may submit a prescription in accordance with subsubparagraph 11(b)(i).\n\n11A. For the purposes of subparagraph 11(a), a prescription that has been prepared and signed by the medical practitioner in accordance with that subparagraph is taken to have been submitted by him or her if it is submitted by one of his or her employees.\n\nAuthorisation of prescriptions for highly specialised drugs\n\n12. Subject to paragraph 13, the authorisation of a prescription for a highly specialised drug may be made:\n\n(a) if the prescription was submitted in accordance with subparagraph 11(a) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:\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 \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 subparagraph 11(b) — orally, at the time the Medicare Australia CEO is given details of the prescription.\n\n12A. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 12(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\n13. Notwithstanding paragraph 12, if the prescription was submitted in accordance with subsubparagraph 11(b)(ii), authorisation shall be deemed to have been granted upon completion by the medical practitioner of the prescription in accordance with the instructions stipulated in the emergency telephone message provided to the medical practitioner by the Medicare Australia CEO.\n\n14. In authorising a prescription for a highly specialised drug under paragraph 12, the Medicare Australia CEO may authorise:\n\n(a) subject to paragraph 14A, the supply of a quantity of number of units of the highly specialised drug sufficient for up to 2 months’ treatment with the highly specialised drug; and\n\n(b) subject to paragraphs 14B, 14C, 14D and 15, up to 5 repeat supplies.\n\n14A. The Medicare Australia CEO may authorise:\n\n(a) in the case of the highly specialised drugs “bosentan monohydrate”, “clozapine”, “etanercept” and “iloprost trometamol”, the supply of a quantity of number of units of the highly specialised drug sufficient for up to 1 month’s treatment with the highly specialised drug;\n\n(b) in the case of a prescription for the highly specialised drug “infliximab” for the treatment of adults with severe active rheumatoid arthritis, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose of 3 mg per kg;\n\n(c) in the case of a prescription for the highly specialised drug “infliximab” for the initial treatment of adults with active ankylosing spondylitis who have not received treatment with either etanercept or infliximab for this condition subsidised under the Pharmaceutical Benefits Scheme (PBS) within at least the previous 5 years and have not received non-PBS-subsidised treatment with infliximab prior to 1 March 2004, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for 2 doses of 5 mg per kg;\n\n(d) in the case of a prescription for the highly specialised drug “infliximab” for initial, or recommencement of, PBS-subsidised treatment with infliximab of adults with active ankylosing spondylitis who have received PBS-subsidised treatment with either etanercept or infliximab for this condition and have not failed PBS-subsidised treatment with infliximab more than once, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for 2 doses of 5 mg per kg;\n\n(e) in the case of a prescription for the highly specialised drug “infliximab” for the initial PBS-subsidised treatment of adults with active ankylosing spondylitis who, at the time of application, are receiving treatment with infliximab, who were receiving treatment with infliximab prior to 1 March 2004, and who have not received prior PBS-subsidised treatment with etanercept, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose of 5 mg per kg;\n\n(f) in the case of a prescription for the highly specialised drug “infliximab” for continuing treatment of adults with active ankylosing spondylitis who demonstrate a response to PBS-subsidised treatment with infliximab, the supply of a quantity of number of units of the highly specialised drug sufficient, based on the weight of the patient, to provide for a single dose of 5 mg per kg.\n\n14B. The Medicare Australia CEO may authorise:\n\n(a) in the case of a prescription for the highly specialised drug “etanercept” for the initial treatment of severe polyarticular course juvenile chronic arthritis, up to 3 repeat supplies of the highly specialised drug;\n\n(b) in the case of a prescription for the highly specialised drug “iloprost trometamol” for the initial PBS-subsidised treatment of patients with primary pulmonary hypertension, pulmonary arterial hypertension secondary to connective tissue disease or drug-induced pulmonary arterial hypertension who were receiving non-PBS-subsidised treatment with iloprost trometamol for less than 6 months prior to 1 April 2005, sufficient repeat supplies of the highly specialised drug to allow the patient to complete a period of combined PBS-subsidised and non-PBS-subsidised therapy of 6 months duration in total.\n\n \n\n14C. The Medicare Australia CEO must not authorise the supply of the highly specialised drug “bosentan monohydrate” to be repeated except in the following situations:\n\n(a) in the case of a prescription for the balance of the 6 months of initial treatment of patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who have been issued with an authority prescription for 1 month of initial PBS-subsidised therapy, up to 4 repeat supplies of the highly specialised drug may be authorised;\n\n(b) in the case of a prescription for continuing PBS-subsidised treatment of patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who have achieved a response to PBS-subsidised treatment, up to 5 repeat supplies of the highly specialised drug may be authorised.\n\n14D. The Medicare Australia CEO must not authorise the supply of the highly specialised drug “infliximab” to be repeated except in the following situations:\n\n(a) in the case of a prescription for the initial treatment of adults with severe active rheumatoid arthritis who have not received PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug for this condition within at least the previous 5 years, up to 3 repeat supplies of the highly specialised drug may be authorised;\n\n(b) in the case of a prescription for the initial treatment, or recommencement of previously ceased infliximab treatment, of adults with severe active rheumatoid arthritis who have received PBS-subsidised treatment with either infliximab or another biological disease modifying anti-rheumatic drug for this condition and are eligible to receive further treatment, up to 3 repeat supplies of the highly specialised drug may be authorised;\n\n(c) in the case of a prescription for the initial PBS-subsidised treatment of adults with severe active rheumatoid arthritis who were receiving treatment with infliximab prior to 1 March 2005 and who failed to qualify for PBS-subsidised treatment after 1 November 2003 due to testing negative for rheumatoid factor, up to 2 repeat supplies of the highly specialised drug may be authorised;\n\n(d) in the case of a prescription for continuing treatment of adults with severe active rheumatoid arthritis who demonstrate an adequate response to PBS-subsidised treatment with infliximab, up to 2 repeat supplies of the highly specialised drug may be authorised;\n\n(e) in the case of a prescription for the initial PBS-subsidised treatment of adults with active ankylosing spondylitis who, at the time of application, are receiving treatment with infliximab and who were receiving treatment with infliximab prior to 1 March 2004, and who have not received prior PBS-subsidised treatment with etanercept, up to 3 repeat supplies of the highly specialised drug may be authorised;\n\n \n\n(f) in the case of a prescription for continuing treatment of adults with active ankylosing spondylitis who demonstrate a response to PBS-subsidised treatment with infliximab (and which is not a prescription for a single dose), up to 3 repeat supplies of the highly specialised drug may be authorised.\n\n15. The Medicare Australia CEO must not authorise the supply of a highly specialised drug 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\n16. Regulation 24 of the Regulations applies to the supply of highly specialised drugs as if the quantity or number of units of the highly specialised drug authorised by the Medicare Australia CEO under paragraph 14 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\n17. Regulation 25 of the Regulations applies to the supply of highly specialised drugs as if highly specialised drugs were pharmaceutical benefits in relation to which the Minister determines, 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.","sortOrder":2},{"sectionNumber":"Supplier of highly specialised drugs und","sectionType":"part","heading":"Supplier of highly specialised drugs under these Arrangements","content":"## Supplier of highly specialised drugs under these Arrangements\n\n18. Highly specialised drugs may be supplied:\n\n(i) by an approved pharmacist; or\n\n(ii) by an approved hospital authority, to a patient receiving treatment at the hospital of which it is the governing body or proprietor;\n\nbut not by an approved medical practitioner.","sortOrder":3},{"sectionNumber":"Cost to patient of highly specialised dr","sectionType":"part","heading":"Cost to patient of highly specialised drugs under these Arrangements","content":"## Cost to patient of highly specialised drugs under these Arrangements\n\n19. An approved pharmacist or an approved hospital authority who supplies a highly specialised drug may charge the person to whom the highly specialised 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\n19A. In addition to the amount that may be charged by an approved pharmacist or an approved hospital authority under paragraph 19, an approved pharmacist or an approved hospital authority who supplies a highly specialised drug which is:\n\n(i) named in column 1 of Schedule 4;\n\n(ii) in the form specified in column 2 of Schedule 4 in relation to that highly specialised drug;\n\n(iii) marketed under the brand specified in column 3 of Schedule 4 in relation to that highly specialised drug; and\n\n(iv) in the quantity or number of units specified in column 4 of Schedule 4 in relation to that highly specialised drug;\n\nmay charge the person to whom the highly specialised drug is supplied the amount calculated by subtracting the amount specified in column 5 of Schedule 4 in relation to that highly specialised drug from the amount specified in column 6 of Schedule 4 in relation to that highly specialised drug.","sortOrder":4},{"sectionNumber":"Payment to supplier of highly specialise","sectionType":"part","heading":"Payment to supplier of highly specialised drugs under these Arrangements","content":"## Payment to supplier of highly specialised drugs under these Arrangements\n\n20. An approved pharmacist or an approved hospital authority who has supplied a highly specialised drug is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of the highly specialised drug exceeds the amount that the approved pharmacist or approved hospital authority was entitled to charge under paragraph 19.\n\n21. The dispensed price for the supply of a highly specialised drug will be ascertained in accordance with paragraphs 22 to 28.\n\n22. The dispensed price for the supply of a highly specialised drug will be —\n\n(a) where a quantity of a highly specialised drug that is ordered and supplied is equal to the quantity contained in the manufacturer’s pack, the sum of:\n\n(i) the price ex manufacturer of the manufacturer’s pack, plus mark-up as specified in paragraph 23, taken to the nearest cent, one half cent being counted as one cent; and\n\n(ii) a dispensing fee equal to the dispensing fee for the supply of a ready-prepared pharmaceutical benefit, specified in the determination under paragraph 98B(1)(a) of the Act that is in force at the time of supply of the highly specialised drug; or\n\n(b) where a quantity of a highly specialised drug that is ordered and supplied is less than the quantity contained in the manufacturer’s pack, the sum of:\n\n(i) the amount calculated in accordance with paragraph 24; and\n\n(ii) a dispensing fee equal to the dispensing fee for the supply of a ready-prepared pharmaceutical benefit, specified in the determination under paragraph 98B(1)(a) of the Act that is in force at the time of supply of the highly specialised drug; or\n\n \n\n(c) where a quantity of a highly specialised drug that is ordered and supplied is more than the quantity contained in the manufacturer’s pack, the sum of:\n\n(i) the price ex manufacturer, plus mark-up as specified in paragraph 23, taken to the nearest cent, one half cent being counted as one cent, for each complete manufacturer’s pack contained in the quantity supplied; and\n\n(ii) the amount calculated in accordance with paragraph 24 in respect of that remainder, if any, of the quantity supplied that is less than the quantity contained in the manufacturer’s pack, as applicable; and\n\n(iii) a dispensing fee equal to the dispensing fee for the supply of a ready-prepared pharmaceutical benefit, specified in the determination under paragraph 98B(1)(a) of the Act that is in force at the time of supply of the highly specialised drug.\n\n23. The mark-up will be —\n\n(a) 10 per cent, where the price ex manufacturer for the manufacturer’s pack is not more than $40.00; or\n\n(b) $4.00, where the price ex manufacturer for the manufacturer’s pack is more than $40.00 but not more than $100.00; or\n\n(c) 4 per cent, where the price ex manufacturer for the manufacturer’s pack is more than $100.00.\n\n24. Where a quantity of a highly specialised drug that is ordered and supplied is less than the quantity contained in the manufacturer’s pack (that is, a broken quantity), the amount referred to in subsubparagraph 22(b)(i) or 22(c)(ii) will be calculated by:\n\n(a) adding the mark-up as specified in paragraph 23 to the price ex manufacturer for the manufacturer’s pack and taking the result to the nearest cent, one half cent being counted as one cent; and\n\n(b) ascertaining the percentage that the quantity or number of units in the broken quantity bears to the quantity or number of units in the manufacturer’s pack; and\n\n(c) taking that percentage, ascertained in accordance with subparagraph (b), of the amount worked out in accordance with subparagraph (a).\n\n25. The dispensed price for the supply of a highly specialised drug will in each case be taken to the nearest cent, one half cent being counted as one cent.\n\n26. Notwithstanding anything contained elsewhere in these Arrangements, the dispensed price for the supply of a quantity of a highly specialised drug will not exceed the dispensed price for a greater quantity of that highly specialised drug.\n\n \n\n27. Where a prescription specifies a quantity of one of the highly specialised drugs referred to in paragraph 10 as being a highly specialised drug the complete pack of which will be supplied regardless of any lesser quantity ordered, the dispensed price will be calculated on the basis that the complete pack was supplied.\n\n28. Where, in accordance with paragraph 27, a medical practitioner, instead of directing a repeated supply of a highly specialised drug, directs the supply on one occasion of a quantity or number of units of the highly specialised drug, not exceeding the total quantity or number of units that could be prescribed if the medical practitioner directed a repeated supply, the dispensed price for the supply of that highly specialised drug will include only one dispensing fee.\n\n29. Where there are 2 or more brands specified in column 4 of Schedule 2 in relation to a highly specialised drug, the dispensed price will be based on the price ex manufacturer of the brand of the highly specialised drug for which the dispensed price for the supply of the highly specialised drug is lowest.\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","sortOrder":5},{"sectionNumber":"Atazanavir Sulfate","sectionType":"part","heading":"Atazanavir Sulfate","content":"## Atazanavir Sulfate","sortOrder":6},{"sectionNumber":"Fosamprenavir Calcium","sectionType":"part","heading":"Fosamprenavir Calcium","content":"## Fosamprenavir Calcium","sortOrder":7},{"sectionNumber":"Column 1","sectionType":"division","heading":"Column 1","content":"### Column 1\n\n### Name of highly specialised drug","sortOrder":8},{"sectionNumber":"Name of highly specialised drug","sectionType":"division","heading":"Name of highly specialised drug","content":"### Column 1\n\n### Name of highly specialised drug","sortOrder":9},{"sectionNumber":"Column 2","sectionType":"part","heading":"Column 2","content":"# Column 2\n\nForm (strength, type, size, etc.)","sortOrder":10},{"sectionNumber":"Column 3","sectionType":"part","heading":"Column 3","content":"# Column 3\n\n# Brand","sortOrder":11},{"sectionNumber":"Brand","sectionType":"part","heading":"Brand","content":"# Column 3\n\n# Brand","sortOrder":12},{"sectionNumber":"Column 4","sectionType":"part","heading":"Column 4","content":"# Column 4\n\nRelevant quantity or number of units","sortOrder":13},{"sectionNumber":"Column 5","sectionType":"part","heading":"Column 5","content":"# Column 5\n\nCommonwealth Price","sortOrder":14},{"sectionNumber":"Column 6","sectionType":"division","heading":"Column 6","content":"### Column 6\n\nPrice claimed by manufacturer","sortOrder":15}],"analysis":{"issue_detection":{"absurdities":[{"type":"circular_definition","section":"2(e)","severity":"medium","reasoning":"Section 2(e) defines 'highly specialised drug' as 'a special pharmaceutical product in relation to which, by virtue of paragraphs 4, 7 and 9, these Arrangements apply.' Paragraph 4 states that 'the special pharmaceutical products to which these Arrangements apply are the highly specialised drugs specified in column 1 of Schedule 1.' So the definition of 'highly specialised drug' depends on what paragraph 4 covers, and paragraph 4 is defined by what is a 'highly specialised drug'. You cannot determine what is a highly specialised drug without consulting paragraph 4, but paragraph 4 already assumes you know what a highly specialised drug is. A reader must already know what qualifies before they can use the definition.","confidence":0.82,"description":"Circular definition of 'highly specialised drug': the term is defined by reference to paragraphs 4, 7 and 9, but those paragraphs themselves use the term 'highly specialised drug' to describe what they are regulating, creating a definitional loop."},{"type":"circular_definition","section":"2(g)","severity":"low","reasoning":"The definition of 'medication for the treatment of HIV or AIDS' at section 2(g) lists items as 'highly specialised drugs', yet 'highly specialised drug' is defined elsewhere in the same section by reference to operative paragraphs that themselves presuppose the definition. The circularity at 2(e) propagates into 2(g). As a practical matter this is a low-severity quirk because the Schedule 1 list makes the drugs identifiable, but as a matter of formal legal drafting the self-referential chain is defective.","confidence":0.7,"description":"The definition of 'medication for the treatment of HIV or AIDS' includes several drugs that are not HIV/AIDS antiretrovirals but are used to treat opportunistic infections (e.g., azithromycin, clarithromycin, rifabutin, valaciclovir). More critically, the definition uses the defined term 'highly specialised drugs' within the definition of a term ('medication for the treatment of HIV or AIDS') that is itself part of the broader definitional framework. If a drug has not yet been confirmed as a 'highly specialised drug' (because that definition is circular per s.2(e)), this list cannot be fully resolved."},{"type":"impossible_compliance","section":"11(b)(ii)","severity":"medium","reasoning":"Subparagraph 11(b)(ii) is activated when the telephone system has failed or is unavailable. Yet it directs the practitioner to follow 'instructions stipulated in an emergency telephone message' — a message that is presumably transmitted via the same telephone system that has just been declared unavailable. The provision attempts to solve a telephony failure by using the telephone. Paragraph 13 compounds this by deeming authorisation granted upon completion of the prescription 'in accordance with the instructions stipulated in the emergency telephone message' — but if the phone is down, the practitioner may never have received those instructions in the first place.","confidence":0.85,"description":"The emergency telephone fallback procedure requires a medical practitioner to follow 'instructions stipulated in an emergency telephone message provided to the medical practitioner by the Medicare Australia CEO', but if the telephone system is unavailable (which is the very trigger for this provision), there is no mechanism specified for how the emergency message is actually delivered to the practitioner — it still presupposes a functioning telephone."},{"type":"other","section":"11AA(b)(ii)","severity":"low","reasoning":"The phrase 'first prescription for continuing PBS-subsidised treatment immediately following a course of therapy initiating' creates temporal ambiguity. The 'initiating' course and 'continuing' treatment are defined as distinct phases, so the boundary prescription sits uncomfortably — it is the last of initiation or the first of continuation? This creates an interpretive gap that neither the practitioner nor the Medicare Australia CEO can resolve with certainty, though in practice administrative guidance likely fills the gap.","confidence":0.65,"description":"The provision allows telephone submission for 'the first prescription for continuing PBS-subsidised treatment... immediately following a course of therapy initiating, or recommencing, PBS-subsidised treatment with infliximab'. A prescription cannot logically be simultaneously the 'first prescription for continuing treatment' and 'immediately following' an initiating course — continuing treatment, by definition, begins only after initiation is complete, meaning there is an inherent ambiguity about when one phase ends and the other begins that could render compliance impossible to verify."},{"type":"self_contradicting","section":"14A(c) and 14A(d)","severity":"medium","reasoning":"Paragraph 14A(c) excludes those who have received PBS-subsidised treatment with 'either etanercept or infliximab for this condition within at least the previous 5 years'. Paragraph 14A(d) includes those who 'have received PBS-subsidised treatment with either etanercept or infliximab for this condition'. A patient with prior PBS-etanercept but no prior PBS-infliximab is excluded from (c) but captured by (d). That logical division works, BUT the quantity authorised is the same in both cases (2 doses of 5mg/kg), so the practical effect is identical, raising the question of why both provisions exist and whether an edge-case patient is being forced to use the wrong category.","confidence":0.6,"description":"Paragraphs 14A(c) and 14A(d) both authorise supply for 'initial' or 'initial, or recommencement of' PBS-subsidised treatment with infliximab for adults with active ankylosing spondylitis, but use subtly different eligibility criteria that partially overlap. The criteria in (c) require no prior PBS-subsidised treatment with either etanercept or infliximab within 5 years AND no non-PBS infliximab before 1 March 2004. Paragraph (d) covers those who HAVE received PBS-subsidised treatment with either drug. However, a patient who received PBS-subsidised etanercept but never PBS-subsidised infliximab could plausibly fall under either (c) or (d), creating an impossible compliance scenario for the prescriber selecting the correct authority."},{"type":"other","section":"14A(e)","severity":"low","reasoning":"Clinically, a patient already established on infliximab at the standard dosing interval would require the same quantity per dose as anyone else. The single-dose authorisation for the transitional/grandfathered cohort in 14A(e) versus 2 doses for those in 14A(c)/(d) appears to reflect a policy choice about managing the transition from non-PBS to PBS funding, but creates an apparent anomaly where longer-standing patients receive less on initial PBS authority than brand-new patients.","confidence":0.55,"description":"Paragraph 14A(e) authorises supply for 'the initial PBS-subsidised treatment of adults with active ankylosing spondylitis who, at the time of application, are receiving treatment with infliximab, who were receiving treatment with infliximab prior to 1 March 2004'. This provision authorises only a single dose, while 14A(c) and (d) covering other 'initial' scenarios authorise 2 doses. A patient grandfathered from pre-2004 treatment who has been on infliximab continuously is paradoxically given less drug on their first PBS claim than a new patient, which appears clinically and logically inverted."},{"type":"self_contradicting","section":"28","severity":"medium","reasoning":"The entire prescription authorisation framework (paragraphs 11–14) requires Medicare Australia CEO approval of quantities. Paragraph 28 implicitly grants the prescriber an independent power to consolidate repeats into a single supply, bypassing the CEO's quantity determination role in paragraph 14. This sits awkwardly within the scheme and could allow a prescriber to circumvent the repeat-supply controls in paragraphs 14B, 14C, 14D and 15.","confidence":0.7,"description":"Paragraph 28 refers to 'a medical practitioner, instead of directing a repeated supply of a highly specialised drug, directs the supply on one occasion of a quantity or number of units...not exceeding the total quantity or number of units that could be prescribed if the medical practitioner directed a repeated supply'. However, the Arrangements do not appear to give the medical practitioner any direct power to 'direct' supply quantities — that authority rests with the Medicare Australia CEO under paragraphs 12 and 14. Paragraph 28 thus confers a power on the prescriber that contradicts the centralised authorisation model established elsewhere."},{"type":"retroactive_impossibility","section":"14B(b)","severity":"high","reasoning":"These Arrangements commence on 1 December 2005. Paragraph 14B(b) targets patients who were receiving non-PBS iloprost for less than 6 months prior to 1 April 2005 — meaning their non-PBS treatment started sometime after 1 October 2004. Even the latest-starting patient in this cohort (starting 31 March 2005) would have been on therapy for at least 8 months by the commencement date of 1 December 2005, well past the 6-month combined total. The transitional provision is therefore spent and incapable of practical application at commencement. No patient can use it.","confidence":0.88,"description":"Paragraph 14B(b) authorises 'sufficient repeat supplies... to allow the patient to complete a period of combined PBS-subsidised and non-PBS-subsidised therapy of 6 months duration in total' for iloprost trometamol patients who received non-PBS treatment for 'less than 6 months prior to 1 April 2005'. By 1 December 2005 (the commencement date of these Arrangements), any patient who started non-PBS treatment on 1 April 2005 would have already completed 8 months of therapy, meaning the 6-month total period has necessarily already expired before these Arrangements even commence. The provision is retroactively impossible to comply with for any patient who began at or before 1 April 2005."}],"contradictions":[{"severity":"medium","section_a":"3","section_b":"18","confidence":0.78,"description":"Section 3 entitles a person receiving treatment 'at a private hospital as a non-admitted patient, day admitted patient or patient on discharge' to receive highly specialised drugs under these Arrangements. Section 18 states that highly specialised drugs may be supplied by an approved hospital authority 'to a patient receiving treatment at the hospital of which it is the governing body or proprietor'. A patient 'on discharge' under section 3 is no longer physically receiving treatment at the hospital, yet the supply restriction in section 18(ii) only covers patients 'receiving treatment at the hospital'. This creates a gap where discharge patients are entitled under section 3 but may not be able to receive supply under section 18."},{"severity":"low","section_a":"5","section_b":"7","confidence":0.55,"description":"Section 5 states that supply of a highly specialised drug is authorised 'only in the circumstances specified in column 2 of Schedule 1'. Section 7 states that where strength, type, unit size or other particulars are specified in columns 2 of Schedules 2 or 3, 'each specified form of the product is a highly specialised drug, and these Arrangements do not apply in relation to the special pharmaceutical product in any other form'. This means the authorised circumstances gate (Schedule 1, col. 2) and the authorised form gate (Schedules 2/3) operate as independent and potentially conflicting filters with no express provision for how a conflict between a Schedule 1 circumstance authorisation and a Schedule 2/3 form restriction is to be resolved."},{"severity":"medium","section_a":"14(b)","section_b":"14D","confidence":0.72,"description":"Section 14(b) states the Medicare Australia CEO 'may authorise... up to 5 repeat supplies' (subject to paragraphs 14B, 14C, 14D and 15). Section 14D however caps infliximab repeats at a maximum of 3 in the most generous cases (paragraphs (a), (b), (e), (f)) and as low as 2 repeats in other cases (paragraphs (c) and (d)). The general power in 14(b) expressly defers to 14D, so no true contradiction arises in practice, but the interaction creates ambiguity: the 'subject to' qualifier in 14(b) is a ceiling override only, meaning the CEO might believe they retain residual discretion to authorise more than 14D's caps where 14D is silent on a particular infliximab indication — potentially allowing up to 5 repeats for an unlisted infliximab scenario, contrary to the restrictive intent of 14D."},{"severity":"medium","section_a":"11AA(b)(i)","section_b":"11AA(b)(ii)","confidence":0.68,"description":"Paragraph 11AA(b) uses 'unless' as the gateway for both sub-provisions (i) and (ii), meaning a practitioner 'may not' submit by telephone UNLESS they satisfy (i) OR (ii). Sub-provision (i) covers the balance-of-repeats scenario; sub-provision (ii) covers the first continuing-treatment prescription for a single dose. These are logically disjunctive, but the structure uses separate 'unless' clauses with 'or' between them, creating ambiguity about whether both conditions must be satisfied simultaneously or whether either one independently unlocks telephone submission. Read literally with the double 'unless', a prescriber could argue neither condition applies to their situation and both gateways are therefore closed, even where the intent was to permit telephone submission in either scenario."},{"severity":"low","section_a":"12A(b)(ii)","section_b":"15","confidence":0.6,"description":"Section 12A(b)(ii) requires the medical practitioner to 'retain a copy of the prescription for 1 year from the date on which the prescription was authorised'. Section 15 prohibits the Medicare Australia CEO from authorising repeated supply for foreign persons entitled under section 7 of the Health Insurance Act 1973. However, nothing in section 15 or section 12A addresses whether the record-keeping obligation in 12A(b)(ii) still applies where an authorisation is refused under section 15 — if the CEO refuses authorisation, was there ever an 'authorised prescription' for the purposes of the 1-year retention clock? The interplay leaves practitioners uncertain whether to retain refused prescriptions."},{"severity":"low","section_a":"26","section_b":"24","confidence":0.5,"description":"Section 26 provides that 'the dispensed price for the supply of a quantity of a highly specialised drug will not exceed the dispensed price for a greater quantity of that highly specialised drug.' Section 24 calculates the price for a broken (partial) pack as a proportional share of the full pack price plus mark-up. Under the section 23 mark-up structure, the mark-up percentage for packs priced above $100 is 4%, meaning the per-unit cost of a broken quantity and a full pack should be identical, causing no breach of section 26. However, for packs priced between $40 and $100, the mark-up is a flat $4.00 rather than percentage-based. A broken quantity from a $41 pack carries a proportional share of the $4 markup, which per-unit is lower than the full-pack price — but section 26 addresses total price, not per-unit price. A scenario where one prescription covers, say, 110% of a pack (paragraph 22(c)) could produce a total dispensed price that paradoxically exceeds the price for a 200% quantity, depending on rounding under section 25, creating a technical breach of section 26."}]},"summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"This instrument is a tightly focused administrative arrangement governing a specific program (Highly Specialised Drugs at private hospitals) under a well-defined head of power (subparagraph 100(1)(b)(i) of the National Health Act 1953). It replaces an earlier version (PB 21 of 2005) and updates the drug lists, pricing, and authorisation rules, but does not expand the program's fundamental purpose or target population. The scope remains consistent with the original design: subsidised access to high-cost specialist medicines for eligible private hospital outpatients, with government oversight of every prescription."},"complexity_factors":["Multiple defined terms referencing other Acts and instruments, including the National Health Act 1953, Health Insurance Act 1973, and the National Health (Pharmaceutical Benefits) Regulations 1960","Tiered and conditional prescription submission rules in paragraphs 11, 11AA and 11A, with drug-specific exceptions nested within exceptions","Highly granular dosing authorisation rules in paragraphs 14A–14D, varying by drug, patient history, treatment stage, and body weight","Three separate schedules (Schedules 1, 2, 3, 4) referenced throughout the body of the instrument but not fully reproduced in the provided text","Complex dispensed price calculation formula across paragraphs 21–29, including pro-rata calculations for broken pack quantities and multi-pack supplies","Manufacturer brand codes (two-letter table) used as cross-references to Schedules, adding an additional layer of indirection","Specific carve-outs for named drugs (infliximab, etanercept, bosentan, iloprost, clozapine) across multiple paragraphs with distinct rules for each","Incorporation by reference of Regulations 24 and 25 with deemed modifications (paragraphs 16 and 17)","Emergency authorisation pathway (subsubparagraph 11(b)(ii) and paragraph 13) with deemed-grant mechanism"],"plain_english_summary":"This instrument establishes the Highly Specialised Drugs (HSD) Program within Australia’s PBS, setting the framework for how certain high-cost, clinically sensitive medicines are prescribed, authorised, dispensed, and paid for when supplied to non-admitted or day patients (including discharged patients) at private hospitals.\n\nIt affects eligible Medicare patients, prescribing medical practitioners, approved pharmacists and hospital suppliers, and Services Australia — ensuring access to subsidised, tightly controlled treatment for conditions like HIV/AIDS and serious autoimmune and rare diseases."}},"importantCases":[],"_links":{"self":"/api/acts/f2005l03741","history":"/api/acts/f2005l03741/history","analysis":"/api/acts/f2005l03741/analysis","conflicts":"/api/acts/f2005l03741/conflicts","importantCases":"/api/acts/f2005l03741/important-cases","documents":"/api/acts/f2005l03741/documents"}}