EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 45 OF 2010
NATIONAL HEALTH ACT 1953
DETERMINATIONS UNDER SECTIONS 85, 85A and 88
Summary
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 15 of 2010 which came into effect on
1 April 2010. The amendments provide for additions and changes to the names, forms and brands of listed drugs on the Pharmaceutical Benefits Scheme (PBS) and the conditions for prescribing pharmaceutical benefits. The amendments are set out in the items of Schedule 1 to the instrument.
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).
A provision-by-provision description of the instrument is contained in the Attachment.
This instrument, expressed to commence on 1 June 2010, was made on 12 May 2010.
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 June 2010.
Paragraph 2: provides that Schedule 1 amends PB 15 of 2010.
Schedule 1: provides for the following amendments:
SCHEDULE 1 ― PART 1
Listed Drugs Added
Alendronic acid with colecalciferol and calcium |
Perindopril with amlodipine |
Listed Drugs Deleted
Amino acid formula without methionine, threonine and valine and low in isoleucine |
Amino acid formula without phenylalanine, tyrosine and methionine |
Mineral mixture |
Forms Added
Clopidogrel | Tablet 75 mg (as besilate) |
Everolimus | Tablet 1 mg |
Mesalazine | Tablet 1.2 g (prolonged release) |
Forms Deleted
Amino acid formula with vitamins and minerals without phenylalanine | Oral powder 400 g (Phenex-2) |
Cetuximab | Solution for I.V. infusion 100 mg in 50 mL |
Clotrimazole | Lotion 10 mg per mL, 20 mL |
Cromoglycic Acid | Pressurised inhalation containing sodium cromoglycate 1 mg per dose, 200 doses |
Follitropin Alfa | Injection set containing 1 vial powder for injection 75 I.U. and 1 pre-filled syringe solvent 1 mL Injection set containing 10 vials powder for injection 75 I.U. and 10 pre-filled syringes solvent 1 mL Injection set containing 1 vial powder for injection 450 I.U. and 1 pre-filled syringe solvent 1 mL Injection set containing 1 vial powder for injection 1,050 I.U. and 1 pre-filled syringe solvent 2 mL |
Glucose Indicator—Blood | Test strips, 100 (Precision Plus) |
Rivaroxaban | Tablets 10 mg, 15 |
Brands Added
Amlodipine | Tablet 5 mg (as besylate) (Amlodipine-DRLA) Tablet 10 mg (as besylate) (Amlodipine-DRLA) |
Amoxycillin | Capsule 500 mg (as trihydrate) (Amoxycillin-GA) |
Cephalexin | Granules for oral suspension 125 mg per 5 mL, 100 mL (APO-Cephalexin) Granules for oral suspension 250 mg per 5 mL, 100 mL (APO-Cephalexin) |
Ciprofloxacin | Tablet 250 mg (as hydrochloride) (Ciprofloxacin-DRLA) Tablet 500 mg (as hydrochloride) (Ciprofloxacin-DRLA) Tablet 750 mg (as hydrochloride) (Ciprofloxacin-DRLA) |
Famciclovir | Tablet 125 mg (Ezovir) Tablet 250 mg (Ezovir, Famciclovir Sandoz) |
Gabapentin | Capsule 300 mg (Gabapentin Sandoz) Capsule 400 mg (Gabapentin Sandoz) Tablet 600 mg (Gabatine 600) Tablet 800 mg (Gabatine 800) |
Levetiracetam | Tablet 250 mg (APO-Levetiracetam, Chem mart Levetiracetam, Levitam 250, Kepcet, Kevtam, Terry White Chemists Levetiracetam) Tablet 500 mg (APO-Levetiracetam, Chem mart Levetiracetam, Levitam 500, Kepcet, Kevtam, Terry White Chemists Levetiracetam) Tablet 1 g (APO-Levetiracetam, Chem mart Levetiracetam, Levitam 1000, Kepcet, Kevtam, Terry White Chemists Levetiracetam) |
Lisinopril | Tablet 5 mg (Lisinopril-DRLA, Lisinopril Sandoz) Tablet 10 mg (Lisinopril-DRLA, Lisinopril-GA) Tablet 20 mg (Lisinopril-DRLA) |
Ramipril | Capsule 1.25 mg (Ramipril-GA) |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (GA Tramadol 50mg) Tablet (sustained release) containing tramadol hydrochloride 100 mg Tablet (sustained release) containing tramadol hydrochloride 150 mg Tablet (sustained release) containing tramadol hydrochloride 200 mg |
Brands Deleted
Amoxycillin | Capsule 250 mg (as trihydrate) (Amoxycillin-DP) |
Gabapentin | Capsule 300 mg (Douglas Gabapentin 300mg, Gabahexal 300mg) Capsule 400 mg (Gabahexal 400mg, Pendine 400) |
Gliclazide | Tablet 30 mg (modified release) (Diamicron MR) |
Lansoprazole | Capsule 15 mg (Zoton) |
Lisinopril | Tablet 5 mg (Lisinopril Hexal) |
Alteration of Form and Maximum Quantity
Glucose Indicator—Blood | From: Test strips, 50 (Accu-Chek Mobile) Max Qty: 2 To: Test strips, 100 (Accu-Chek Mobile) Max Qty: 1 |
Alteration of Brands
Atenolol | Tablet 50 mg From: Atehexal To: Atenolol Sandoz |
Captopril | Tablet 25 mg From: Genepharm Pty Ltd To: Ascent Pharma Pty Ltd Tablet 50 mg From: Captohexal To: Captopril Sandoz Tablet 50 mg From: Genepharm Pty Ltd To: Ascent Pharma Pty Ltd |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) From: Genepharm (Australia) Limited To: Ascent Pharmaceuticals Limited Tablet 750 mg (as hydrochloride) From: Genepharm (Australia) Limited To: Ascent Pharmaceuticals Limited |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg From: Diltahexal To: Diltiazem Sandoz |
Glucose | I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited I.V. infusion 278 mmol (anhydrous) per L, 1 L From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited |
Metformin | Tablet containing metformin hydrochloride 500 mg From: Genepharm (Australia) Limited To: Ascent Pharmaceuticals Limited Tablet containing metformin hydrochloride 850 mg From: Genepharm (Australia) Limited To: Ascent Pharmaceuticals Limited |
Norfloxacin | Tablet 400 mg From: Genepharm Pty Ltd To: Ascent Pharmaceuticals Limited |
Sodium Chloride | I.V. infusion 77 mmol per 500 mL, 500 mL From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited I.V. infusion 154 mmol per L, 1 L From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited |
Sodium Lactate Compound | I.V. infusion containing approximately 65 mmol sodium (as lactate and chloride), 2.7 mmol potassium (as chloride), 0.9 mmol calcium (as chloride), 14 mmol bicarbonate (as lactate) and 56 mmol chloride per 500 mL, 500 mL From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), 29 mmol bicarbonate (as lactate) and 111 mmol chloride per L, 1 L From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited |
SCHEDULE 1 ― PART 2
Form Added
Rivaroxaban | Tablets 10 mg, 10 |
Form Deleted
Cetuximab | Solution for I.V. infusion 100 mg in 50 mL |
Brands Added
Famciclovir | Tablet 250 mg (Ezovir, Famciclovir Sandoz) Tablet 500 mg (Ezovir) |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (GA Tramadol 50mg) Tablet (sustained release) containing tramadol hydrochloride 100 mg Tablet (sustained release) containing tramadol hydrochloride 150 mg Tablet (sustained release) containing tramadol hydrochloride 200 mg |
Alteration of Form and Maximum Quantity
Glucose Indicator—Blood | From: Test strips, 50 (Accu-Chek Mobile) Max Qty: 2 To: Test strips, 100 (Accu-Chek Mobile) Max Qty: 1 |
Alteration of Maximum Quantity
Rivaroxaban | Tablet 10 mg From: 10 To: 15 |
SCHEDULE 3 ― PART 1
Brands Added
Amoxycillin | Capsule 500 mg (as trihydrate) (Amoxycillin-GA) |
Cephalexin | Granules for oral suspension 125 mg per 5 mL, 100 mL (APO-Cephalexin) Granules for oral suspension 250 mg per 5 mL, 100 mL (APO-Cephalexin) |
Tramadol | Capsule containing tramadol hydrochloride 50 mg (GA Tramadol 50mg) Tablet (sustained release) containing tramadol hydrochloride 100 mg Tablet (sustained release) containing tramadol hydrochloride 150 mg Tablet (sustained release) containing tramadol hydrochloride 200 mg |
Brand Deleted
Amoxycillin | Capsule 250 mg (as trihydrate) (Amoxycillin-DP) |
Alteration of Brands
Glucose | I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited I.V. infusion 278 mmol (anhydrous) per L, 1 L From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited |
Sodium Chloride | I.V. infusion 77 mmol per 500 mL, 500 mL From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited I.V. infusion 154 mmol per L, 1 L From: Pharmatel Fresenius Kabi Pty Limited To: Fresenius Kabi Australia Pty Limited |