National Health Act 1953 - Amendment special arrangements under subsection 100(1) - Highly Specialised Drugs Program (No. PB 113 of 2009)

EXPLANATORY STATEMENT

INSTRUMENT NUMBER PB 113 of 2009

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.  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 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 54 of 2009) which came into effect on 1 July 2009.  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 December 2009, was made on 13 November 2009.

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.  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 December 2009.

Paragraph 2:  provides that Schedule 1 amends PB 54 of 2009.

Schedule 1: provides for the following amendments: 

Addition of the highly specialised drug “ambrisentan” to subparagraph 11AA(a) provides that a medical practitioner may not seek authorisation to prescribe ambrisentan from the Medicare Australia CEO by telephone, unless the Medicare Australia CEO has previously authorised a written application to prescribe ambrisentan for that patient for that circumstance and the maximum allowable number of repeats was not authorised at that time.  In such case the medical practitioner may seek authorisation by telephone to prescribe the balance of the allowable repeats.

Addition of the highly specialised drug “ambrisentan” to subparagraph 14A(a) provides that the Medicare Australia CEO may authorise the prescription of a quantity of number of units of the highly specialised drug “ambrisentan” sufficient for up to 1 month’s treatment.

Amendment of subparagraph 14A(g) by the addition of the words “up to” is to clarify that the Medicare Australia CEO may authorise the prescription of a quantity of number of units of the highly specialised drug “cinacalcet” sufficient for "up to" 4 weeks treatment at a dose of 30 to 180 mg per day.

Addition of subparagraph 14A(i) provides that the Medicare Australia CEO may authorise in the case of a prescription for the highly specialised drug "lenalidomide", the supply of a quantity of number of units of the highly specialised drug sufficient for up to 21 days treatment.

Addition of subparagraph 14B(l) provides that the Medicare Australia CEO may authorise in the case of a prescription for the highly specialised drug “ambrisentan” for initial             PBS-subsidised treatment of patients who were receiving non-PBS-subsidised treatment with ambrisentan for less than 6 months prior to 1 December 2009, 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 up to 6 months duration in total.

Addition of subparagraph 14B(m) provides that the Medicare Australia CEO may authorise in the case of a prescription for the highly specialised drug "lenalidomide”, up to 2 repeat supplies.

SCHEDULE 1

Addition of Highly Specialised Drug

Alteration of Circumstances

SCHEDULE 2

Addition of Highly Specialised Drug