EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 85B(1)
NO. PB 17 OF 2006
Purpose and operation
- The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.
2. The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.
3. “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.
4. Subsection 85B(1) of the Act enables the Minister to determine those pharmaceutical benefits for which there exists a price difference between what the Government is prepared to subsidise and that required by the manufacturer, and to determine in respect of each of those benefits the price to pharmacist which is to be used as a basis for reimbursement and the price to pharmacist sought by the manufacturer. Section 85B is used for special patient contribution items, for the therapeutic group premium policy and for the brand premium policy.
5. The determination sets out the conditions under which subsection 85B(1) applies. The Schedule to the determination lists those pharmaceutical benefits to which subsection 85B(1) applies, the form (strength, type, size etc.), the brand, the pack size, the price to pharmacist that the Government is prepared to pay and the price to pharmacist that the manufacturer requires.
6. The determination made under section 85B(1) of the Act on 22 February 2006 with effect from 1 March 2006 (No. PB 11 of 2006) is repealed and substituted with this determination.
7. This determination is remade to give effect, as from 1 April 2006, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as recommended by the Pharmaceutical Benefits Committee. Changes to the Schedule to this determination are detailed in the attached summary of changes.
Consultations
8. 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.
9. The determination gives effect to recommendations made by the PBAC. 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.
10. Details of the determination are set out in the Attachment.
11. This determination is a legislative instrument for the purposes of the
Legislative Instruments Act 2003.
12. The determination was made on 24 March 2006 and commenced on 1 April 2006.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Deletions
AD Amrad Pharmaceuticals Pty Ltd
TC Technostic Consulting Pty Ltd
Brands to which a special patient contribution now applies
Lansoprazole Sachet containing granules for oral suspension, 30 mg per
sachet (WY)
Brands to which a brand premium now applies
Bupropion Hydrochloride Tablet 150 mg (sustained release) (GK)
Mirtazapine Tablet 45 mg (BP)
Ondansetron Wafer 4 mg (GK)
Wafer 8 mg (GK)
Ondansetron Hydrochloride Tablet equivalent to 4 mg ondansetron (GK)
Dihydrate Tablet equivalent to 8 mg ondansetron (GK)
I.V. injection equivalent to 4 mg ondansetron in 2 mL
ampoule (GK)
I.V. injection equivalent to 8 mg ondansetron in 4 mL
ampoule (GK)
Brands to which a brand premium will no longer apply (brand discontinued by the manufacturer)
Methotrexate Tablet 2.5 mg (WY)
Norfloxacin Tablet 400 mg (FR)
Brands to which a brand premium will no longer apply (price decrease)
Trimethoprim with Tablet 80 mg-400 mg (SI)
Sulfamethoxazole
Vancomycin Hydrochloride Powder for injection equivalent to 500 mg (500,000 I.U.)
vancomycin activity (AS)
Verapamil Hydrochloride Tablet 120 mg (AB)
Brands with an increased brand premium
Alendronate Sodium Tablet equivalent to 70 mg alendronic acid (MK)
Betamethasone Valerate Cream equivalent to 500 micrograms betamethasone
per g, 15 g (SI)
Ointment equivalent to 500 micrograms betamethasone
per g, 15 g (SI)
Brimonidine Tartrate Eye drops 2 mg per mL, 5 mL (AG)
Carbamazepine Tablet 100 mg (NV)
Tablet 200 mg (NV)
Ciprofloxacin Hydrochloride Tablet equivalent to 750 mg ciprofloxacin (BN)
Clomipramine Hydrochloride Tablet 25 mg (NV)
Cyclosporin Capsule 50 mg (NV)
Digoxin Tablet 62.5 micrograms (SI)
Tablet 250 micrograms (SI)
Gliclazide Tablet 80 mg (SE)
Glyceryl Trinitrate Tablets 600 micrograms, 100 (SI)
Hydrocortisone Acetate Cream 10 mg per g, 30 g (SI)
Cream 10 mg per g, 50 g (SI)
Ointment 10 mg per g, 30 g (SI)
Ointment 10 mg per g, 50 g (SI)
Lamotrigine Tablet 50 mg (GK)
Leflunomide Tablet 10 mg (AV)
Mirtazepine Tablet 30 mg (BP)
Nizatidine Capsule 150 mg (AS)
Capsule 300 mg (AS)
Oxazepam Tablet 30 mg (SI)
Phenoxymethylpenicillin Oral suspension equivalent to 125 mg
Benzathine phenoxymethylpenicillin per 5 mL, 100 mL (SI)
Oral suspension equivalent to 250 mg
phenoxymethylpenicillin per 5 mL, 100 mL (SI)
Pilocarpine Hydrochloride Eye drops 5 mg per mL, 15 mL (AG)
Eye drops 10 mg per mL, 15 mL (AG)
Eye drops 20 mg per mL, 15 mL (AG)
Eye drops 60 mg per mL, 15 mL (AG)
Potassium Chloride Tablet 600 mg (sustained release) (NV)
Temazepam Tablet 10 mg (SI)
Tramadol Hydrochloride Capsule 50 mg (CS)
Tablet 100 mg (sustained release) (CS)
Tablet 150 mg (sustained release) (CS)
Tablet 200 mg (sustained release) (CS)
Brands with a decreased brand premium
Cyclosporin Capsule 100 mg (HX)
Paraffin - Soft White with Pack containing 2 tubes eye ointment, compound, 3.5 g (AG)
Paraffin – Liquid
Brands with price changes but no change in brand premium
Brinzolamide Eye drops 10 mg per mL, 5 mL (AQ)
Ciprofloxacin Hydrochloride Tablet equivalent to 250 mg ciprofloxacin (BN)
Tablet equivalent to 500 mg ciprofloxacin (BN)
Eye drops equivalent to 3 mg ciprofloxacin
per mL, 5 mL (AQ)
Clindamycin Hydrochloride Capsule equivalent to 150 mg clindamycin (PH)
Cyclosporin Capsule 25 mg (HX, NV)
Capsule 50 mg (HX)
Capsule 100 mg (NV)
Glimepiride Tablet 1 mg (AV)
Tablet 2 mg (AV)
Tablet 3 mg (AV)
Tablet 4 mg (AV)
Lamotrigine Tablet 5 mg (GK)
Tablet 25 mg (GK)
Tablet 100 mg (GK)
Tablet 200 mg (GK)
Leflunomide Tablet 20 mg (AV)
Omeprazole Magnesium Tablet equivalent to 20 mg omeprazole (AP)
Paraffin - Soft White with Eye ointment, compound, 3.5 g (AQ)
Paraffin - Liquid
Alteration of Manufacturer’s Code
From To
Cephalothin Sodium Powder for injection equivalent to 1 g LY AS
cephalothin
Cephazolin Sodium Powder for injection equivalent to 1 g LY AS
cephazolin
Enalapril Maleate Tablet 5 mg AD FR
Tablet 10 mg AD FR
Tablet 20 mg AD FR
Simvastatin Tablet 5 mg AD FR
Tablet 10 mg AD FR
Tablet 20 mg AD FR
Tablet 40 mg AD FR
Tablet 80 mg AD FR
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 April 2006.
Paragraph 2 provides that the determination under subsection 85B(1) of the National Health Act 1953 made on 22 February 2006 (No. PB 11 of 2006) is repealed.
Paragraph 3 defines the term “authority prescription”.
Paragraph 4 provides that the Schedule to the determination lists those brands of pharmaceutical benefits to which subsection 85B(1) apply.
Paragraph 5 provides that where a form and brand of pharmaceutical benefit is listed in Part A of the Schedule, Part B of the Schedule lists the quantity or number of units that is to be used for determining the manufacturer’s price for sales, and the price claimed by the manufacturer, for that form and brand.
Paragraph 6 provides that Part C of the Schedule lists the manufacturer’s price for sales for a particular form and brand that is listed in Part A of the Schedule.
Paragraph 7 provides that Part D of the Schedule lists the price claimed by the manufacturer for a particular form and brand that is listed in Part A of the Schedule.
Paragraph 8 lists those pharmaceutical benefits for which section 85B of the Act will not apply, if the prescription was written before 1 April 2006 and the pharmaceutical benefit is supplied before 1 October 2006.
Paragraph 9 lists the names of the manufacturers of those brands of pharmaceutical benefits, listed under “Brand” in Part A of the Schedule, to which this determination applies.
The Schedule to the determination lists those pharmaceutical benefits to which subsection 85B(1) applies, the form (strength, type, size etc.), the brand, the pack size, the price to pharmacist that the Government is prepared to pay and the price to pharmacist that the manufacturer requires.