EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
ARRANGEMENTS UNDER SECTION 100
SPECIAL AUTHORITY PROGRAM
NO. PB 37 OF 2005
Purpose and operation
- The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
2. The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
3. “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:
(a) who are living in isolated areas; or
(b) who are receiving medical treatment in such circumstances that pharmaceutical benefits:
(i) cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or
(ii) are inadequate for that medical treatment.
5. Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
6. Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
7. The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits. Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.
8. The Special Authority Program is a set of Arrangements made under subparagraph 100(1)(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who require treatment with imatinib mesylate.
9. The Special Authority Program Arrangements made under subparagraph 100(1)(b)(i) of the Act on 26 July 2005, with effect from 1 August 2005 (No. PB 23 of 2005), are repealed and substituted with these Arrangements.
10. These Arrangements were remade on 23 November 2005 to give effect, as from 1 December 2005, to the special arrangements for the supply of imatinib mesylate available under the Special Authority Program under section 100, as recommended by the Pharmaceutical Benefits Advisory Committee
11. Amendment of Schedule 2 of the Instrument is required to make it clear that, for the treatment of patients in the chronic phase of chronic myeloid leukaemia:
- applications for authority for initial treatment may be supported, amongst other specified requirements, by a qualitative PCR report documenting the presence of the bcr-abl transcript in either peripheral blood or bone marrow; and
- applications for authority for continuing therapy may be supported, amongst other specified requirements, by a quantitative PCR analysis of peripheral blood providing bcr-abl transcript levels, where failure to obtain a bone marrow sample (dry tap) has occurred on two separate occasions.
12. These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
13. Details of the Arrangements are set out in the Attachment.
Consultations
14. The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits. Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
15. PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
ATTACHMENT
The Preamble states the authority for the making of these Arrangements.
Paragraph 1(a) provides that these Arrangements commence on 1 December 2005.
Paragraph 1(b) provides that the Arrangements made on 26 July 2005, with effect from 1 August 2005, are repealed with effect from commencement of these Arrangements.
Paragraph 2 provides that a word or phrase used in these Arrangements will be taken to have the same meaning as in the National Health Act 1953 (the Act), the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations, unless the contrary intention appears. Paragraph 2 also defines certain terms used in these Arrangements.
Paragraph 3 provides that the provisions of the Act, the Regulations, declarations, determinations and other instruments made under the Act shall apply to the prescribing of imatinib mesylate under these Arrangements, except where otherwise specified in these Arrangements.
Paragraph 4 provides that a person is entitled to receive imatinib mesylate under these Arrangements, without payment or other consideration, other than the charges specified in paragraph 17, if that person is an eligible person within the meaning of the Health Insurance Act 1973, and if that person is receiving treatment by medical practitioner.
Paragraph 5 provides that the supply of imatinib mesylate under these Arrangements is authorised only in the circumstances specified in Schedule 1 or Schedule 2.
Paragraph 6 provides that imatinib mesylate is available for oral administration under these Arrangements in the following forms marketed under the following brands:
Form (strength, type, size, etc.) Proprietary name Manufacturer
Tablet 100 mg (base) (pack of 60) Glivec Novartis Pharmaceuticals Australia Pty Ltd
Tablet 400 mg (base) (pack of 30) Glivec Novartis Pharmaceuticals Australia Pty Ltd
Paragraph 7 provides that, subject to paragraph 12, the maximum quantity of imatinib mesylate that may be prescribed on a prescription is:
(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);
(b) in respect of the tablet 400 mg, 1 pack of 30 tablets.
Paragraph 8 provides that the maximum number of repeats that may be prescribed on a prescription for imatinib mesylate is:
(a) 5, in the case of a prescription for the treatment of the chronic phase of chronic myeloid leukaemia; or
(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
(c) 2, in the case of a prescription for the treatment of a metastatic or unresectable malignant gastrointestinal stromal tumour.
Subparagraph 9(1) provides that, subject to subparagraph 9(2), when prescribing imatinib mesylate the medical practitioner must:
(a) prepare and sign the prescription:
(i) in a form approved by the Secretary, and completed in ink in the medical practitioner’s handwriting; or
(ii) in a computer-prepared form that is accordance with the form approved by the Secretary under subsubparagraph (i); or
(iii) in a computer-prepared form approved in writing for the purpose by the Secretary and in a format approved in writing by the Secretary; or
(iv) by a method approved by the Secretary in writing; and
(b) submit the prescription and where appropriate, the material specified in Schedule 1 or 2, by
(i) sending the prescription to the specified address of Medicare Australia; or
(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, submitting the prescription by telephone, by giving the Medicare Australia CEO the details of that prescription which has been prepared and signed in accordance with subparagraph (1)(a);
Subparagraph 9(2) provides that 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 9(1)(a).
Paragraph 10 provides that the Medicare Australia CEO may authorise a prescription:
(a) by signing that prescription if it was submitted in accordance with subparagraph 9(1)(a) and:
(i) if an alteration is required by the Medicare Australia CEO, returning the prescription to the medical practitioner for alteration before the treatment is given to the patient; or
(ii) in any other case by returning it to the medical practitioner, or sending it to the patient; or
(b) orally if the prescription was submitted by telephone in accordance with subparagraph 9(1)(b)(ii).
Paragraph 11 provides that if the Medicare Australia CEO authorises a prescription in accordance with subparagraph 10(b):
(a) the Medicare Australia CEO must tell the medical practitioner the number that has been allotted to that authorised prescription; and
(b) the medical practitioner must mark the authorisation number on the prescription and retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
Paragraph 12 provides that Regulation 13 of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) applies to the prescribing of imatinib mesylate only to the extent that:
(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;
(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.
Paragraph 13 provides that the Medicare Australia CEO must not authorise the repeat supply of a imatinib mesylate 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.
Paragraph 14 provides that 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.
Paragraph 15 provides that 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 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.
Paragraph 16 provides that imatinib mesylate may be supplied by:
(a) an approved pharmacist; or
(b) by an approved medical practitioner; or
(c) by an approved hospital authority, to a patient receiving treatment at the hospital of which it is the governing body or proprietor; or
(d) by an approved hospital that is not participating in the arrangements set out in Appendix F to the Australian Health Care Agreements, but is approved by Medicare Australia to issue safety net concession cards and pharmaceutical benefits entitlement cards.
Paragraph 17 describes the cost to patients of the supply of imatinib mesylate under these Arrangements. An approved supplier may charge the person to whom imatinib mesylate has been supplied an amount equal to that which may be charged under section 87 of the Act for the supply of a pharmaceutical benefit.
Paragraph 18 describes the payments that may be made to an approved supplier by the Commonwealth for the supply of imanitib mesylate under these Arrangements. 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 21 of 2005 applies to imatinib mesylate.
The Schedules
Schedule 1 to the Arrangements lists the circumstances for which imatinib mesylate may be prescribed as a special pharmaceutical product for the treatment of adult patients with metastatic or unresectable malignant gastrointestinal stromal tumour. The procedures for authorising a prescription of imatinib mesylate as a special pharmaceutical product for the treatment of adult patients with metastatic or unresectable malignant gastrointestinal stromal tumour are also detailed in this Schedule.
Schedule 2 to the Arrangements lists the circumstances for which imatinib mesylate may be prescribed as a special pharmaceutical product for the treatment of patients in the chronic, accelerated or blast phases of chronic myeloid leukaemia. The procedures for authorising a prescription of imatinib mesylate as a special pharmaceutical product for the treatment of patients in the chronic, accelerated or blast phases of chronic myeloid leukaemia are also detailed in this Schedule.