EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 4 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)
AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)
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 in relation to which Part VII applies are declared by the Minister by legislative instrument as such under subsection 85(2). These are listed drugs as defined in subsection 84(1). Part VII also applies to certain extemporaneously-prepared medicinal preparations as a result of declarations under paragraph 85(2)(b).
The Minister by legislative instrument can determine the form or forms of a listed drug by reference to strength, type of unit, size of unit or otherwise (subsection 85(3)); the manner of administration of the form of the listed drug so determined (subsection 85(5)); and a brand of the pharmaceutical item (defined in subsection 84(1)) that has the listed drug in that form with that manner of administration (subsection 85(6)). These determinations govern (except for certain extemporaneously-prepared pharmaceutical benefits) what constitutes the pharmaceutical benefit (defined in subsection 84(1)) under Part VII of the Act.
Subsection 85(2AA) empowers the Minister, by legislative instrument, to revoke or vary a declaration under subsection 85(2) in relation to a drug or medicinal preparation.
Where a revocation or variation would have the result that a drug or medicinal preparation would cease to be a listed drug, the Minister must under subsection 85(2AB) obtain the advice in writing of the Pharmaceutical Benefits Advisory Committee (PBAC). Under subsection 85(2AC), this PBAC advice is to be tabled in Parliament with the relevant declaration under subsection 85(2AA). Subsection 101(4) further provides that a drug or medicinal preparation cannot be declared under paragraph 85(2)(a) to be a drug or medicinal preparation in relation to which Part VII applies unless the PBAC has recommended to the Minister that it be so declared.
This legislative instrument in giving effect to recommendations of the PBAC, amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 113 of 2008 which came into effect on 1 December 2008. The amendments declare changes to the list of drugs and medicinal preparations available as pharmaceutical benefits and the circumstances in which the pharmaceutical benefits may be prescribed. 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 2010, was made on 2 February 2010.
Consultations
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation. The PBAC is an independent expert body established by section 100A which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations 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. When recommending the listing of a medicine 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.
ATTACHMENT
Paragraph 1: provides that this instrument commences on 1 March 2010.
Paragraph 2: provides that Schedule 1 amends PB 113 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Addition of Listed Drugs
Nebivolol |
Rizatriptan |
Triglycerides, long chain with glucose polymer |
Ustekinumab |
Deletion of Listed Drug
Influenza Vaccine |
Alteration of Circumstances
Adalimumab | [addition of the drug ustekinumab to the list of interchangeable biological agents for the treatment of severe chronic plaque psoriasis and amendment of definition of Biological Treatment Cycle] |
Albendazole | [in respect of the tablet 200 mg, additional availability for strongyloidiasis and for the treatment of hookworm infestation] |
Alendronic Acid | [amendment of “Paget’s disease” to “Paget disease” and consequent change to the streamlined authority code] |
Bicalutamide | [addition of streamlined authority code 3247] |
Candesartan with Hydrochlorothiazide | [addition of the tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 12.5 mg and the tablet containing candesartan cilexetil 32 mg with hydrochlorothiazide 25 mg] |
Clopidogrel | [amendment of circumstance for the treatment of acute coronary syndrome and consequent change to streamlined authority code] |
Clopidogrel with aspirin | [amendment of circumstance for the treatment of acute coronary syndrome and consequent change to streamlined authority code] |
Etanercept | [addition of the drug ustekinumab to the list of interchangeable biological agents for the treatment of severe chronic plaque psoriasis and amendment of definition of Biological Treatment Cycle] |
Etidronic Acid | [amendment of “Paget’s disease” to “Paget disease” and consequent change to the streamlined authority code] |
Fluconazole | [extension of availability for the prophylaxis of oropharyngeal candidiasis in immunosuppressed patients] |
Gefitinib | [removal of the requirement that mutation of the epidermal growth factor receptor gene must be demonstrated by DNA sequencing] |
Glucose Indicator—Blood | [addition of the test strips, 50 (Accu-Chek Mobile) and deletion of the test strips, 50 (Glucoboy)] |
Goserelin | [in respect of the subcutaneous implant 3.6 mg (as acetate) in pre-filled injection syringe, extension of availability for the treatment of hormone-dependent breast cancer; and in respect of the subcutaneous implant (long acting) 10.8 mg (as acetate) in pre-filled injection syringe, addition of streamlined authority code 3229] |
Goserelin and Bicalutamide | [addition of streamlined authority code 3239] |
Imatinib | [amendment of circumstances relating to the treatment of gastrointestinal stromal tumour] |
Lapatinib | [removal of the circumstance relating to patients receiving initial treatment with lapatinib prior to 1 May 2008] |
Memantine | [removal of the circumstance relating to patients commenced on memantine treatment prior to 1 March 2008] |
Olanzapine | [addition of the powder for injection 405 mg (as pamoate monohydrate) with diluent] |
Pamidronic Acid | [amendment of “Paget’s disease” to “Paget disease” and consequent change to the streamlined authority code] |
Risedronic Acid | [amendment of “Paget’s disease” to “Paget disease” and consequent change to the streamlined authority code] |
Salcatonin | [amendment of “Paget’s disease” to “Paget disease” and consequent change to the streamlined authority code] |
Terbinafine | [addition of streamlined authority code 3243 and corresponding circumstance in respect of the cream containing terbinafine hydrochloride 10 mg per g, 15 g; and in respect of the tablet 250 mg (as hydrochloride), additional availability for the treatment of a dermatophyte infection in a patient aged up to 18 years] |
Tiludronic Acid | [amendment of “Paget’s disease” to “Paget disease” and consequent change to the streamlined authority code] |
SCHEDULE 1A
Addition of Listed Drug
Methylnaltrexone |