EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 98 OF 2008
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATIONS UNDER SECTIONS 85, 85A and 88
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 to which Part VII applies are declared by the Minister by legislative instrument to be so 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).
Subsection 85(3) authorises the Minister by legislative instrument to determine by reference to strength, type of unit, size of unit, or otherwise, the form or forms of a listed drug.
Subsection 85(5) authorises the Minister by legislative instrument to determine the manner of administration of a form of a listed drug where the form has been determined under subsection 85(3).
Subsection 85(6) authorises the Minister by legislative instrument to determine a brand of a pharmaceutical item. A “brand” is defined in subsection 84(1) to mean the trade name which the person who is or will be the “responsible person” supplies the pharmaceutical item, or if there is no trade name, the name of the responsible person. The responsible person for a brand of a pharmaceutical item is determined by the Minister by legislative instrument under section 84AF.
Subsection 85A(2) authorises the Minister to determine various matters with respect to the writing of prescriptions by persons included in a specified class of persons for the supply of a pharmaceutical benefit. Paragraph 85A(2)(a) authorises the determination of the maximum quantity or number of units that may in one prescription be directed to be supplied for all purposes or for a particular purpose. Paragraph 85A(2)(b) authorises the determination of the maximum number of occasions in which the supply may in one prescription be directed to be repeated for all purposes or a particular purpose. Paragraph 85A(2)(c) authorises the determination of the manner of administration that may in a prescription be directed to be used.
Section 88 provides for various matters relating to the prescribing of pharmaceutical benefits. Subsection 88(1A) authorises the Minister to determine the pharmaceutical benefits for the supply of which a dental practitioner is authorised to write a prescription.
This instrument determines matters under subsections 85(3), 85(5), 85(6), 85A(2), and 88(1A).
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends determinations under sections 85, 85A and 88 made by legislative instrument number PB 75 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 75 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 – PART 1
Forms Added
Insulin Glulisine | Injection (human analogue) 100 units per mL, 10 mL |
Mesalazine | Sachet containing granules, 1.5 g per sachet |
Paroxetine | Tablet 20 mg (as mesilate) |
Quetiapine | Tablet (modified release) 50 mg (as fumarate) Tablet (modified release) 200 mg (as fumarate) Tablet (modified release) 300 mg (as fumarate) Tablet (modified release) 400 mg (as fumarate) |
Tramadol | Tablet (extended release) containing tramadol hydrochloride 100 mg Tablet (extended release) containing tramadol hydrochloride 200 mg Tablet (extended release) containing tramadol hydrochloride 300 mg |
Brands Added
Amisulpride | Tablet 400 mg (Amipride 400) |
Amlodipine | Tablet 5 mg (as besylate) (Amlotrust 5) Tablet 10 mg (as besylate) (Amlotrust 10) |
Carvedilol | Tablet 3.125 mg (GN-Carvedilol) Tablet 6.25 mg (GN-Carvedilol) Tablet 12.5 mg (GN-Carvedilol) Tablet 25 mg (GN-Carvedilol) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL (Irinotecan-GA) |
Lamotrigine | Tablet 25 mg (Lamotrigine-GA) Tablet 50 mg (Lamotrigine-GA) Tablet 100 mg (Lamotrigine-GA) Tablet 200 mg (Lamotrigine-GA) |
Forms Deleted
Cabergoline | Tablet 4 mg |
Epirubicin | Powder for injection containing epirubicin hydrochloride 50 mg |
Brands Deleted
Lisinopril | Tablet 5 mg (Lisinotrust 5) Tablet 10 mg (Lisinotrust 10) Tablet 20 mg (Lisinotrust 20) |
Sertraline | Tablet 50 mg (as hydrochloride) (Sertratrust 50) Tablet 100 mg (as hydrochloride) (Sertratrust 100) |
Simvastatin | Tablet 10 mg (Simvatrust 10) Tablet 20 mg (Simvatrust 20) Tablet 40 mg (Simvatrust 40) Tablet 80 mg (Simvatrust 80) |
Alteration of Form
Polyethylene Glycol 400 with Propylene Glycol | From: Eye drops 4 mg-3 mg per mL, single dose units 0.7 mL, 28 To: Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28 |
Tramadol |
From: Tablet containing tramadol hydrochloride 50 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 50 mg |
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From: Tablet containing tramadol hydrochloride 100 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 100 mg |
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From: Tablet containing tramadol hydrochloride 150 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 150 mg |
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From: Tablet containing tramadol hydrochloride 200 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 200 mg |
Alteration of Maximum Quantity
Polyethylene Glycol 400 with Propylene Glycol | Eye drops 4 mg-3 mg per mL, single dose units 0.8 mL, 28 From: 3 To: 2 |
Alteration of Maximum Number of Repeats
Nilotinib | Capsule 200 mg (as hydrochloride monohydrate) From: 5 To: 2 |
Alteration of Brand Name
Pancreatic Extract | Capsule (containing enteric coated minimicrospheres) providing not less than 10,000 BP units of lipase activity From: Creon To: Creon 10,000 |
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Capsule (containing enteric coated minimicrospheres) providing not less than 25,000 BP units of lipase activity From: Creon Forte To: Creon 25,000 |
SCHEDULE 1 – PART 2
Items Added
Carbomer 980 | Ocular lubricating gel 2 mg per g, 10 g |
Carmellose | Eye drops containing carmellose sodium 5 mg per mL, 15 mL Eye drops containing carmellose sodium 10 mg per mL, 15 mL |
Hypromellose | Eye drops 3 mg per mL, 15 mL Eye drops 5 mg per mL, 15 mL |
Hypromellose with Carbomer 980 | Ocular lubricating gel 3 mg-2 mg per g, 10 g |
Hypromellose with Dextran | Eye drops containing 3 mg hypromellose 4500 with 1 mg dextran 70 per mL, 15 mL |
Nilotinib | Capsule 200 mg (as hydrochloride monohydrate) |
Paraffin | Eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g Pack containing 2 tubes eye ointment, compound, containing white soft paraffin with liquid paraffin, 3.5 g |
Polyethylene Glycol 400 with Propylene Alcohol | Eye drops 4 mg-3 mg per mL, 15 mL |
Polyvinyl Alcohol | Eye drops 14 mg per mL, 15 mL Eye drops 14 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) Eye drops 30 mg per mL, 15 mL Eye drops 30 mg per mL, 15 mL (contains sodium chlorite/hydrogen peroxide as preservative) |
Sulfasalazine | Tablet 500 mg Tablet 500 mg (enteric coated) |
Tramadol | Tablet (extended release) containing tramadol hydrochloride 100 mg Tablet (extended release) containing tramadol hydrochloride 200 mg Tablet (extended release) containing tramadol hydrochloride 300 mg |
Forms Added
Dasatinib | Tablet 20 mg [different Maximum number of repeats] Tablet 50 mg [different Maximum number of repeats] Tablet 70 mg [different Maximum number of repeats] |
Alteration of Purposes
Bortezomib (and amended from misspelt “Botezomib”) |
Dasatinib |
Imatinib [continuing restrictions for “Myelodysplastic or myeloproliferative disorder” and “Systemic mastocytosis with eosinophilia”] |
Alteration of Form
Tramadol | From: Tablet containing tramadol hydrochloride 50 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 50 mg |
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From: Tablet containing tramadol hydrochloride 100 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 100 mg |
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From: Tablet containing tramadol hydrochloride 150 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 150 mg |
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From: Tablet containing tramadol hydrochloride 200 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 200 mg |
SCHEDULE 3 – PART 1
Forms Added
Tramadol | Tablet (extended release) containing tramadol hydrochloride 100 mg Tablet (extended release) containing tramadol hydrochloride 200 mg Tablet (extended release) containing tramadol hydrochloride 300 mg |
Alteration of Form
Tramadol | From: Tablet containing tramadol hydrochloride 50 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 50 mg |
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From: Tablet containing tramadol hydrochloride 100 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 100 mg |
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From: Tablet containing tramadol hydrochloride 150 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 150 mg |
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From: Tablet containing tramadol hydrochloride 200 mg (sustained release) To: Tablet (sustained release) containing tramadol hydrochloride 200 mg |