EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 54 OF 2010
NATIONAL HEALTH ACT 1953
AMENDMENT DECLARATION UNDER SUBSECTIONS 85(2) AND 85(2AA)
AMENDMENT DETERMINATION UNDER SUBSECTION 85(2A)
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends declarations under subsections 85(2) and 85(2AA) and the determination under subsection 85(2A) made by legislative instrument number PB 14 of 2010 which came into effect on 1 April 2010. The amendments declare additions and 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.
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 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.
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 July 2010, was made on 3 June 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 July 2010.
Paragraph 2: provides that Schedule 1 amends PB 14 of 2010.
Schedule 1: provides for the following amendments:
SCHEDULE 1
Alteration of Circumstances
Adrenaline | [addition of the names EpiPen Jr. and Epipen to the form descriptions of the I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector and the I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector respectively; addition of the I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior) and I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen); circumstances amended to specify treatment is for intitial and continuing “sole” PBS-subsidised supply] |
Bevacizumab | [circumstances altered to specify the maximum dose approved for initial and continuing treatment of patients with metastatic colorectal cancer] |
Bimatoprost with timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Bisoprolol | [circumstances altered to define the conventional therapy on which a patient with moderate to severe heart failure is stabilised and consequent change to the streamlined authority code] |
Brimonidine with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Carvedilol | [circumstances altered to define the conventional therapy on which a patient with moderate to severe heart failure is stabilised and consequent change to the streamlined authority code] |
Docetaxel | [circumstances altered in respect of the treatment of advanced breast cancer] |
Dorzolamide with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Esomeprazole | [additional availability for the treatment of scleroderma oesophagus and pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion] |
Lapatinib | [circumstances altered for the treatment of patients with HER2 positive metastatic breast cancer] |
Latanoprost with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Medroxyprogesterone | [deletion of the injection containing medroxyprogesterone acetate 50 mg in 1 mL] |
Mesalazine | [alteration of form description of the suppository 1 g] |
Metoprolol succinate | [circumstances altered to define the conventional therapy on which a patient with moderate to severe heart failure is stabilised and consequent change to the streamlined authority code] |
Paclitaxel | [circumstances altered in respect of the treatment of advanced breast cancer] |
Paclitaxel, nanoparticle albumin-bound | [circumstances altered in respect of the treatment of metastatic breast cancer] |
Pioglitazone | [circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code] |
Rosiglitazone | [circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code] |
Rosiglitazone with Metformin | [circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code] |
Rosuvastatin | [additional availability for the treatment of patients who are receiving treatment under a GP Management Plan or Team Care Arrangements where Medicare benefits were or are payable for the preparation of the Plan or coordination of the Arrangements |
Sitagliptin | [circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code] |
Sitagliptin with metformin | [circumstances altered for the treatment of patients with type 2 diabetes and consequent change to the streamlined authority code] |
Travoprost with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
SCHEDULE 2
Addition of Listed Drug
Roxithromycin
SCHEDULE 2A
Alteration of Circumstances
Bimatoprost with timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Brimonidine with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Dorzolamide with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Latanoprost with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |
Travoprost with Timolol | [circumstances altered for the reduction of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension] |