EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 65 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 July 2008, was made on 3 June 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 July 2008.
Paragraph 2: provides that Schedule 1 amends PB 92 of 2007.
Schedule 1: provides for the following amendments:
Amendment of subparagraph 2(h) to add “raltegravir” to the list of highly specialised drugs for the treatment of HIV or AIDS.
Amendment of subparagraph 14(b) to include reference to paragraph 14E.
Amendment of paragraph 14A provides that the Medicare Australia CEO may authorise the supply of a quantity of the highly specialised drug “cinacalcet” to provide for 4 weeks treatment at a dose of 30 to 180 mg per day [addition of subparagraph g] and the supply of a single infusion of the highly specialised drug “natalizumab” [addition of subparagraph h].
Amendment of paragraph 14B provides that the Medicare Australia CEO may authorise up to 2 repeat supplies of the highly specialised drug “natalizumab” for the continuing treatment of relapsing-remitting multiple sclerosis [addition of subparagraph l].
Addition of paragraph 14E which provides that the Medicare Australia CEO must not authorise the supply of the highly specialised drug “cinacalcet” except in specified circumstances when up to 5 repeat supplies may be authorised.
SCHEDULE 1
Addition of listed drug
Cinacalcet
Natalizumab
Raltegravir
Alteration of Circumstances
Adefovir
Entecavir
Filgrastim
Iloprost
Infliximab
Interferon Alfa-2a
Interferon Alfa-2b
Lamivudine
Pegfilgrastim
Peginterferon Alfa-2a
Sevelamer
SCHEDULE 2
Addition of listed drug
Cinacalcet Tablet 30 mg (as hydrochloride)
Tablet 60 mg (as hydrochloride)
Tablet 90 mg (as hydrochloride)
Natalizumab Solution concentrate for I.V. infusion 300 mg in 15 mL
Raltegravir Tablet 400 mg (as potassium)
Alteration of Brand
In all instances the brand “Hospira Australia Pty Ltd” is changed to the brand
“Hospira Pty Limited”