National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Highly Specialised Drugs Program (No. PB 27 of 2008)

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 27 of 2008

NATIONAL HEALTH ACT 1953

AMENDMENT SPECIAL ARRANGEMENTS UNDER SUBSECTION 100(1)

HIGHLY SPECIALISED DRUGS PROGRAM

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 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.

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 private hospitals as non-admitted patients, day admitted patients or patients on discharge.

This legislative instrument amends the Arrangements made under subparagraph 100(b)(i) (PB 92 of 2007) which came into effect on 1 December 2007.  The amendments are set out in the items of Schedule 1 to the instrument.

A provision-by-provision description of the instrument is contained in the Attachment.

This instrument, expressed to commence on 1 March 2008, was made on 1 February 2008.

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 March 2008.

Paragraph 2:  provides that Schedule 1 amends PB 92 of 2007.

Schedule 1: provides for the following amendments: 

SUMMARY OF CHANGES

Amendment of subparagraph 11AA(a) provides for the addition of “abatacept” to the list of drugs for which a medical practitioner may submit a prescription to the Medicare Australia CEO in accordance with subparagraph 11(b)(i) provided that a previous prescription has been submitted in accordance with subparagraph 11(a) and less than the maximum allowable repeats was authorised.

Addition of subparagraph 11AA(c) provides that a medical practitioner may not submit a prescription for the drug "rituximab" to the Medicare Australia CEO in accordance with subparagraph 11(b).

Amendment of subparagraph 14(b) provides for the addition of reference to subparagraph 14D. Subparagraph 14(b) provides the number of repeat supplies the Medicare Australia CEO may authorise for a prescription for a highly specialised drug subject to paragraphs 14B, 14C, 14D and 15.

Amendment of subparagraph 14A(e) changes the manner in which the quantity of drug that the Medicare Australia CEO may authorise to be supplied in the case of a prescription for “rituximab” is expressed.

Addition of subparagraph 14A(f) provides that the Medicare Australia CEO may authorise the supply of a quantity of drug sufficient for one dose in the case of a prescription for “abatacept”.

Addition of subparagraph 14B(k) provides that the Medicare Australia CEO may authorise up to 4 repeats in the case of a prescription for “abatacept” for the treatment of adults with severe active rheumatoid arthritis in circumstances which permit a course of up to 16 weeks of treatment to be authorised.

Amendment of paragraph 14D changes the manner in which a prescription for which the Medicare Australia CEO may authorise 1 repeat supply of “rituximab” is described.

SCHEDULE 1

Additions

Abatacept

Ibandronic acid

Sevelamer

Alteration of Circumstances

Adefovir

Entecavir

Filgrastim [addition of circumstance for the treatment of breast cancer and alteration of circumstance for the                      treatment of non-Hodgkin lymphoma]

Infliximab [for the initial treatment of adult patients with severe active psoriatic arthritis and for the treatment of                      adult patients with severe active rheumatoid arthritis]

Interferon Alfa-2a [for the treatment of chronic hepatitis B]

Interferon Alfa–2b [for the treatment of chronic hepatitis B]

Lamivudine

Pegfilgrastim [for the treatment of non-Hodgkin lymphoma]

Peginterferon Alfa-2a [for the treatment of chronic hepatitis B]

Rituximab

SCHEDULE 2

Additions

Deletion