EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 101 of 2010
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR PUBLIC HOSPITALS) SPECIAL ARRANGEMENTS AMENDMENT INSTRUMENT 2010 (No. 4)
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends Highly Specialised Drugs Program Arrangements under subparagraph 100(b)(i) made by legislative instrument number
PB 63 of 2010 which came into effect on 1 July 2010. The amendments provide for changes to highly specialised drugs available at public hospitals to non-admitted patients, day admitted patients or patients on discharge. The amendments are set out in the items of Schedule 1 to the instrument.
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1).
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.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
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. Under subsection 100AA(1)(c) a special pharmaceutical product, for which special arrangements may be made under section 100, includes a drug or medicinal preparation declared under subsection 85(2) of the Act. 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.
The Highly Specialised Drugs Program is a set of Arrangements made under subparagraph 100(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs at public hospitals as non-admitted patients, day admitted patients or patients on discharge.
These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 November 2010, was made on 29 October 2010.
Consultations
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.
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.
The Commonwealth/State Highly Specialised Drugs Working Party (HSDWP) is a non-statutory body established by the Australian Health Ministers Advisory Council (AHMAC). The HSDWP makes recommendations to the PBAC on the suitability of certain drugs for listing under the Highly Specialised Drugs Program. The HSDWP considers the funding and administrative aspects of supply through the hospital system, and a recommendation for listing must be supported by a majority of Working Party members. The HSDWP consists of representatives from State and Territory Health Departments and the Australian Private Hospitals Association, and is chaired by a representative of the Commonwealth Department of Health and Ageing.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 November 2010.
Paragraph 2: provides that Schedule 1 amends PB 63 of 2010.
Schedule 1: provides for the following amendments:
Preamble paragraphs:
Section 3(1) is amended to include adalimumab in the list of complex authority required drugs.
Section 8 is amended to clarify that medical practitioners who are eligible to prescribe Highly Specialised Drugs are not required in all cases to be located at a public hospital, by omitting the words “at a public hospital”.
Section 21(2)(h) is added to indicate the maximum quantity or number of units which the medical practitioner may authorise to be supplied in the case of a prescription for adalimumab.
Section 23(2)(a) is amended to reflect the alteration to the circumstances in which the supply of etanercept may be authorised.
Section 23(2)(l) is added to indicate the maximum number of repeat supplies which the medical practitioner may authorise in the case of a prescription for adalimumab.
Section 27(1)(a) is amended to include adalimumab in the list of highly specialised drugs that have restrictions on submitting prescriptions to the Medicare Australia CEO.
Section 39(2) has been amended to clarify that an approved hospital authority for a hospital may not make a paperless claim for the supply of a non-CAR drug in circumstances where the prescription directs the supply of either:
- a quantity of a non-CAR drug exceeding the maximum quantity, or
- a number of repeats exceeding the maximum number of repeats.
A prescriber may direct such a supply, in compliance with the requirements in Section 18, but the supplier may not make a paperless claim for the supply.
SCHEDULE 1
Addition of Listed Drug
Adalimumab |
Alteration of Circumstances
Etanercept | [amended availability for the treatment of patients with juvenile idiopathic arthritis (previously termed chronic juvenile arthritis)] |
SCHEDULE 2
Addition of Listed Drug
Adalimumab | Injection 20 mg in 0.4mL pre-filled syringe Injection 40 mg in 0.8 mL pre-filled syringe Injection 40 mg in 0.8 mL pre-filled pen |
Addition of Forms
Tacrolimus | Capsule 0.5 mg (once daily prolonged release) Capsule 1 mg (once daily prolonged release) Capsule 5 mg (once daily prolonged release) |
Thalidomide | Capsule 100 mg |
SCHEDULE 3
Price Decrease
The price claimed by manufacturer for all forms of cyclosporine listed in Schedule 3 has been amended to reflect a price decrease.