EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 85B(1)
NO. PB 34 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determination made under section 85B(1) of the Act on 15 June 2006 with effect from 1 July 2006 (No. PB 27 of 2006) is repealed and substituted with this determination.
7. This determination is remade to give effect, as from 1 August 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 26 July 2006 and commenced on 1 August 2006.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Brands to which a therapeutic group premium now applies
Ramipril Tablet 1.25 mg (AV, ML)
Tablet 2.5 mg (AV, ML)
Tablet 5 mg (AV, ML)
Capsule 10 mg (ML)
Pack containing 7 tablets 2.5 mg, 21 tablets 5 mg and 10
capsules 10 mg (AV)
Brands to which a therapeutic group premium will no longer apply (brand discontinued by the manufacturer)
Cimetidine Hydrochloride Tablet, effervescent, equivalent to 800 mg cimetidine
(GK)
Brands with an increased therapeutic group premium
Lercanidipine Hydrochloride Tablet 20 mg (SM)
Nifedipine Tablet 20 mg (controlled release) (BN)
Ramipril Capsule 10 mg (AV)
Brands with an decreased therapeutic group premium
Lercanidipine Hydrochloride Tablet 10 mg (SM)
Brands with price changes but no change in therapeutic group premium
Ranitidine Hydrochloride Syrup equivalent to 150 mg ranitidine per 10 mL, 300mL (GK)
Brands with price change but no change in special patient contribution
Lansoprazole Sachet containing granules for oral suspension, 30 mg per
sachet (WY)
Brands to which a brand premium now applies
Cefotaxime Powder for injection 1 g (SZ)
Powder for injection 2 g (SZ)
Fluvastatin Sodium Capsule equivalent to 20 mg fluvastatin (NM)
Capsule equivalent to 40 mg fluvastatin (NM)
Imipramine Hydrochloride Tablet 10 mg (NV)
Tablet 25 mg (NV)
Quinapril Hydrochloride Tablet equivalent to 5 mg quinapril (PF)
Tablet equivalent to 10 mg quinapril (PF)
Tablet equivalent to 20 mg quinapril (PF)
Brands to which a brand premium will no longer apply (brand discontinued by the manufacturer)
Amitriptyline Hydrochloride Tablet 25 mg (MK)
Cimetidine Tablet 800 mg (GK)
Flucloxacillin Magnesium with Powder for oral suspension equivalent to 125 mg
Water – Purified BP flucloxacillin per 5 mL, 100 mL (GK)
Brands with an increased brand premium
Aciclovir Tablet 200 mg, Packsize 25 (GK)
Tablet 200 mg, Packsize 90 (GK)
Tablet 800 mg, Packsize 35 (GK)
Tablet 800 mg, Packsize 120 (GK)
Amoxycillin Trihydrate Tablet equivalent to 1 g amoxycillin (GK, SZ)
Capsule equivalent to 250 mg amoxycillin (GK)
Capsule equivalent to 500 mg amoxycillin (GK)
Amoxycillin Trihydrate with Tablet equivalent to 500 mg amoxycillin-125 mg
Potassium Clavulanate clavulanic acid (GK)
Tablet equivalent to 875 mg amoxycillin-125 mg
clavulanic acid (GK)
Amoxycillin Trihydrate with Powder for oral suspension equivalent to 125 mg
Potassium Clavulanate and amoxycillin-31.25 mg clavulanic acid per 5 mL, 75 mL (GK)
Water – Purfied BP Powder for oral suspension equivalent to 400 mg
amoxycillin-57 mg clavulanic acid per 5 mL, 60 mL (GK)
Amoxycillin Trihydrate with Powder for oral suspension equivalent to 125 mg
Water – Purfied BP amoxycillin per 5 mL, 100 mL (GK)
Powder for oral suspension equivalent to 250 mg
amoxycillin per 5 mL, 100 mL (GK)
Captopril Tablet 12.5 mg (BQ)
Tablet 25 mg (BQ)
Tablet 50 mg (BQ)
Cefaclor Monohydrate Tablet (sustained release) equivalent to 375 mg cefaclor (AS)
Cefaclor Monohydrate with Powder for oral suspension equivalent to 125 mg cefaclor per
Water-Purified BP 5 mL, 100 mL (AS)
Powder for oral suspension equivalent to 250 mg cefaclor per
5 mL, 75 mL (AS)
Cephalexin Capsule 250 mg (anhydrous) (AS)
Capsule 500 mg (anhydrous) (AS)
Cephalexin with Water- Granules for oral suspension 125 mg per 5 mL, 100 mL (AS)
Purified BP Granules for oral suspension 250 mg per 5 mL, 100 mL (AS)
Cimetidine Tablet 200 mg (GK)
Tablet 400 mg (GK)
Cyproterone Acetate Tablet 50 mg , Packsize 20 (SC)
Tablet 50 mg , Packsize 50 (SC)
Tablet 100 mg , Packsize 20 (SC)
Diltiazem Hydrochloride Capsule 360 mg (controlled delivery) (AV)
Enalapril Maleate Tablet 5 mg (FR, MK)
Tablet 10 mg (FR, MK)
Tablet 20 mg (FR, MK)
Famotidine Tablet 20 mg (MK)
Tablet 40 mg (MK)
Felodipine Tablet 2.5 mg ( extended release) (AP)
Tablet 5 mg ( extended release) (AP)
Tablet 10 mg ( extended release) (AP)
Levonorgestrel with Tablets 150 micrograms-30 micrograms, 21 (SC)
Ethinyloestradiol Pack containing 21 tablets 150 micrograms-30 micrograms
and 7 inert tablets (SC)
Pack containing 6 tablets 50 micrograms-30 micrograms, 5
tablets 75 micrograms-40 micrograms, 10 tablets 125
micrograms-30 micrograms and 7 inert tablets (SC)
Lisinopril Tablet 5 mg (AP, MK)
Tablet 10 mg (AP, MK)
Tablet 20 mg (AP, MK)
Medroxyprogesterone Acetate Injection 150 mg in 1 mL vial (PH)
Mianserin Hydrochloride Tablet 10 mg (OR)
Tablet 20 mg (OR)
Mirtazapine Tablet 30 mg (BP)
Tablet 45 mg (BP)
Nifedipine Tablet 30 mg (controlled release) (BN)
Tablet 60 mg (controlled release) (BN)
Nitzatidine Capsule 150 mg (AS)
Capsule 300 mg (AS)
Parrafin – Soft White with Pack containing 2 tubes eye ointment, compound, 3.5 g (AG)
Parrafin - Liquid
Piperazine Oestrone Sulfate Tablet 1.46 mg (PH)
Ramipril Tablet 1.25 mg (AV)
Ranitidine Hydrochloride Tablet equivalent to 150 mg ranitidine (GK)
Tablet equivalent to 300 mg ranitidine (GK)
Trandolapril Capsule 500 micrograms (KN)
Capsule 1 mg (KN)
Capsule 2 mg (KN)
Brands with a decreased brand premium
Levonorgestrel with Pack containing 21 tablets 150 micrograms-30 micrograms
Ethinyloestradiol and 7 inert tablets (WY)
Pack containing 6 tablets 50 micrograms-30 micrograms, 5
tablets 75 micrograms-40 micrograms, 10 tablets 125
micrograms-30 micrograms and 7 inert tablets (WY)
Norethisterone with Tablets 500 micrograms-35 micrograms, 21 (PH)
Ethinyloestradiol Pack containing 21 tablets 500 micrograms-35micrograms
and 7 inert tablets (PH)
Tablets 1 mg-35 micrograms, 21 (PH)
Pack containing 21 tablets 1 mg-35micrograms
and 7 inert tablets (PH)
Pack containing 12 tablets 500 micrograms-35micrograms, 9
tablets 1mg-35 micrograms and 7 inert tablets (PH)
Pravastatin Sodium Tablet 10 mg (BQ)
Tablet 20 mg (BQ)
Tablet 40 mg (BQ)
Tablet 80 mg (BQ)
Ramipril Tablet 2.5 mg (AV)
Tablet 5 mg (AV)
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 August 2006.
Paragraph 2 provides that the determination under subsection 85B(1) of the National Health Act 1953 made on 15 June 2006 (No. PB 27 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.