EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 97 OF 2008
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.
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 74 of 2008 which came into effect on 1 August 2008. 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 November 2008, was made on 2 October 2008.
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 November 2008.
Paragraph 2: provides that Schedule 1 amends PB 74 of 2008.
Schedule 1: provides for the following amendments:
Amendment of Paragraph 3 to add the definitions for “GP Management Plan” and “Team Care Arrangements”. The provisions and definitions of the “GP Management Plan” and “Team Care Arrangements” are set out in the Health Insurance (General Medical Services Table) Regulations 2008.
SCHEDULE 1
Alteration of Circumstances
Atomoxetine
Bortezomib
Cabergoline [deletion of the form tablet 4 mg]
Carbomer 980 [addition of circumstance for ocular lubricating gel 2 mg per g, 10 g]
Carmellose [addition of circumstance for eye drops containing carmellose sodium 5 mg per mL, 15 mL and eye drops containing carmellose sodium 10 mg per mL, 15 mL]
Dasatinib [for the treatment of patients with “Chronic myeloid leukaemia”]
Hypromellose
Hypromellose with Carbomer 980
Hypromellose with Dextran [addition of circumstance for eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL]
Imatinib [for the continuing treatment of patients with “Myelodysplastic or myeloproliferative disorder” and “Systemic mastocytosis with eosinophilia”]
Mesalazine [addition of the sachet containing granules, 1.5 g per sachet]
Nilotinib
Polyethylene Glycol 400 with Propylene Glycol [addition of circumstance for eye drops 4 mg-3 mg per mL, 15 mL; alteration to the form for eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28]
Polyvinyl Alcohol
Quetiapine [addition of the tablet (modified release) 50 mg (as fumarate), tablet (modified release) 200 mg (as fumarate), tablet (modified release) 300 mg (as fumarate) and tablet (modified release) 400 mg (as fumarate) and addition of new circumstances] [specify that tablet 25 mg (as fumarate), tablet 100 mg (as fumarate), tablet 200 mg (as fumarate) and tablet 300 mg (as fumarate) relate to the existing circumstance]
Rosiglitazone
Rosiglitazone with Metformin
Thyrotropin Alfa
Tramadol [alteration to the form description for the tablet (sustained release) containing tramadol hydrochloride 50 mg, tablet (sustained release) containing tramadol hydrochloride 100 mg, tablet (sustained release) containing tramadol hydrochloride 150 mg and tablet (sustained release) containing tramadol hydrochloride 200 mg and addition of tablet (extended release) containing tramadol hydrochloride 100 mg, tablet (extended release) containing tramadol hydrochloride 200 mg and tablet (extended release) containing tramadol hydrochloride 300 mg]
SCHEDULE 2
Alteration of Circumstances
Tramadol [alteration to the form description for the tablet (sustained release) containing tramadol hydrochloride 50 mg, tablet (sustained release) containing tramadol hydrochloride 100 mg, tablet (sustained release) containing tramadol hydrochloride 150 mg and tablet (sustained release) containing tramadol hydrochloride 200 mg and addition of tablet (extended release) containing tramadol hydrochloride 100 mg, tablet (extended release) containing tramadol hydrochloride 200 mg and tablet (extended release) containing tramadol hydrochloride 300 mg]
SCHEDULE 2A
Alteration of Circumstances
Polyethylene Glycol 400 with Propylene Glycol [alteration to the form description for eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28]