EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
DETERMINATION UNDER SUBSECTION 85B(1)
NO. PB 19 OF 2005
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.
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.
“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.
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.
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.
The determination made under section 85B(1) of the Act on 22 March 2005 with effect from 1 April 2005 is repealed and substituted with this determination.
This determination is remade to give effect, as from 1 August 2005, to changes to the list of drugs and medicinal preparations available as pharmaceutical benefits, as recommended by the Pharmaceutical Benefits Committee. Paragraph 3 to the determination has been amended to clarify the meaning of "authority prescriptions". A new paragraph 8 has been inserted into the determination to provide that section 85B of the Act will not apply for certain pharmaceutical benefits prescribed before 1 August 2005 and supplied before 1 March 2006. Changes to the Schedule to this determination are detailed in the attached summary of changes.
Consultations
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.
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.
Details of the determination are set out in the Attachment.
This determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
The determination was made on 26 July 2005 and commenced on 1 August 2005.
SUMMARY OF CHANGES
LIST OF MANUFACTURERS
Additions
UC UCB Pharma A Division of UCB Australia Pty Ltd
Brands to which a special patient contribution now applies
Escitalopram Oxalate Tablet equivalent to 10 mg escitalopram (LU)
Tablet equivalent to 20 mg escitalopram (LU)
Oral solution equivalent to 10 mg escitalopram per mL,
28 mL (LU)
Levetiracetam Tablet 250 mg (UC)
Tablet 500 mg (UC)
Tablet 1 g (UC)
Pemetrexed Disodium Powder for I.V. infusion equivalent to 500 mg pemetrexed, vial
Heptahydrate (LY)
Topiramate Tablet 25 mg (JC)
Tablet 50 mg (JC)
Tablet 100 mg (JC)
Tablet 200 mg (JC)
Capsule 15 mg (JC)
Capsule 25 mg (JC)
Capsule 50 mg (JC)
Brands with an increased therapeutic group premium
Amlodipine Besylate Tablet equivalent to 5 mg amlodipine (unless supplied on
an authority prescription) (PF)
Tablet equivalent to 10 mg amlodipine (unless supplied on
an authority prescription) (PF)
Lercanidipine Hydrochloride Tablet 10 mg (unless supplied on an authority prescription)
(SM)
Tablet 20 mg (unless supplied on an authority prescription)
(SM)
Brands to which a brand premium now applies
Clarithromycin Tablet 250 mg (AB)
Lamotrigine Tablet 5 mg (GK)
Simvastatin Tablet 5 mg (AD)
Tablet 5 mg (MK)
Brand to which a brand premium will no longer apply (brand deleted from the PBS)
Frusemide Tablet 500 mg (AV)
Brands with an increased brand premium
Carbamazepine Tablet 100 mg (NV)
Codeine Phosphate with Tablet 30 mg-500 mg (SW)
Paracetamol
Dexamethasone Sodium Ear drops 500 micrograms (dexamethasone)-5 mg-
Metasulfobenzoate with 50 micrograms per mL, 8 mL (AV)
Framycetin Sulfate and
Gramicidin
Diltiazem Hydrochloride Capsule 360 mg (controlled delivery) (AV)
Fluvoxamine Maleate Tablet 50 mg (SM)
Tablet 100 mg (SM)
Glimepiride Tablet 1 mg (AV)
Tablet 2 mg (AV)
Tablet 3 mg (AV)
Tablet 4 mg (AV)
Ipratropium Bromide Nebuliser solution 500 micrograms (anhydrous) in 1 mL
single dose units, 30 (BY)
Ketoprofen Capsule 200 mg (sustained release) (AV)
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)
Methyldopa Tablet 250 mg (MK)
Metoprolol Tartrate Tablet 50 mg (NV)
Tablet 100 mg (NV)
Mirtazapine Tablet 30 mg (OR)
Polyvinyl Alcohol Eye drops 14 mg per mL, 15 mL (AG)
Eye drops 30 mg per mL, 15 mL (AG)
Potassium Chloride Tablet 600 mg (sustained release) (NV)
Prochlorperazine Maleate Tablet 5 mg (AV)
Propranolol Hydrochloride Tablet 40 mg (AP)
Roxithromycin Tablet 150 mg (AV)
Tablet 300 mg (AV)
Simvastatin Tablet 10 mg (AD)
Tablet 10 mg (MK)
Tramadol Hydrochloride Tablet 100 mg (sustained release) (CS)
Tablet 150 mg (sustained release) (CS)
Tablet 200 mg (sustained release) (CS)
Brands with a decreased brand premium
Ipratropium Bromide Nebuliser solution 250 micrograms (anhydrous) in 1 mL
single dose units, 30 (BY)
Lamotrigine Tablet 50 mg (GK)
Simvastatin Tablet 80 mg (AD)
Tablet 80 mg (MK)
Brands with price changes but no change in brand premium
Citalopram Hydrobromide Tablet equivalent to 20 mg citalopram (LU)
Fluoxetine Hydrochloride Tablet, dispersible, equivalent to 20 mg fluoxetine (LY)
Capsule equivalent to 20 mg fluoxetine (LY)
Glyceryl Trinitrate Tablets 600 micrograms, 100 (SI)
Hypromellose 4500 with Eye drops 3 mg-1 mg per mL, 15 mL (AQ)
Dextran 70
Lamotrigine Tablet 25 mg (GK)
Tablet 100 mg (GK)
Tablet 200 mg (GK)
Mirtazapine Tablet 30 mg (BP)
Moclobemide Tablet 150 mg (RO)
Tablet 300 mg (RO)
Paroxetine Hydrochloride Tablet equivalent to 20 mg paroxetine (GK)
Propranolol Hydrochloride Tablet 10 mg (AP)
Sertraline Hydrochloride Tablet equivalent to 50 mg sertraline (PF)
Tablet equivalent to 100 mg sertraline (PF)
Simvastatin Tablet 20 mg (AD)
Tablet 20 mg (MK)
Tablet 40 mg (AD)
Tablet 40 mg (MK)
ATTACHMENT
Paragraph 1 provides that this determination commences on 1 August 2005.
Paragraph 2 provides that the determination under subsection 85B(1) of the National Health Act 1953 made on 22 March 2005 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 August 2005 and the pharmaceutical benefit is supplied before 1 March 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.