EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 63 OF 2009
NATIONAL HEALTH ACT 1953
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 114 of 2008 which came into effect on 1 December 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 August 2009, was made on 6 July 2009.
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 August 2009.
Paragraph 2: provides that Schedule 1 amends PB 114 of 2008.
Schedule 1: provides for the following amendments:
SCHEDULE 1 ― PART 1
Listed Drugs Added
Arsenic |
Bimatoprost with timolol |
High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate |
Praziquantel |
Rivaroxaban |
Sitagliptin with metformin |
Soy lecithin |
Forms Added
Etanercept | Injection 50 mg in 1 mL single use injection pen, 4 |
Gemcitabine | Solution concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL |
Glucose | I.V. infusion 69.5 mmol (anhydrous) per 250 mL, 250 mL I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL I.V. infusion 278 mmol (anhydrous) per 500 mL, 500 mL |
Glucose Indicator―Blood | Electrode strips, 50 (MyGlucoHealth) |
Oxybutynin | Transdermal patches 36 mg, 8 |
Sodium Chloride | I.V. infusion 38.5 mmol per 250 mL, 250 mL I.V. infusion 77 mmol per 500 mL, 500 mL |
Voriconazole | Powder for oral suspension 40 mg per mL, 70 mL |
Alteration of Form
Teriparatide | From: Injection 250 micrograms per mL, 3 mL in multi-dose pre-filled pen To: Injection 250 micrograms per mL, 2.4 mL in multi-dose pre-filled pen |
Brands Added
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (APO-Amoxycillin/Clavulanic Acid 500/125) Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (Curam) Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL |
Azithromycin | Tablet 500 mg (as dihydrate) (Azithromycin Sandoz) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Bisoprolol Sandoz, Bispro 2.5) Tablet containing bisoprolol fumarate 5 mg (Bisoprolol Sandoz, Bispro 5) Tablet containing bisoprolol fumarate 10 mg (Bisoprolol Sandoz, Bispro 10) |
Cabergoline | Tablet 500 micrograms (Tinexa) Tablet 1 mg (Bergoline 1) Tablet 2 mg (Bergoline 2) |
Citalopram | Tablet 20 mg (as hydrobromide) (APO-Citalopram) |
Clarithromycin | Tablet 250 mg (APO-Clarithromycin) |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg |
Escitalopram | Tablet 10 mg (as oxalate) (Lexam 10) Tablet 20 mg (as oxalate) (Lexam 20) |
Glucose | I.V. infusion 278 mmol (anhydrous) per L, 1 L (B. Braun Australia Pty Ltd) |
Lisinopril | Tablet 20 mg (Lisinopril Sandoz) |
Morphine | Tablet containing morphine sulfate 10 mg (controlled release) (Momex SR 10) Tablet containing morphine sulfate 30 mg (controlled release) (Momex SR 30) Tablet containing morphine sulfate 60 mg (controlled release) (Momex SR 60) Tablet containing morphine sulfate 100 mg (controlled release) |
Nifedipine | Tablet 30 mg (controlled release) (APO-Nifedipine XR) Tablet 60 mg (controlled release) (APO-Nifedipine XR) |
Paclitaxel | Solution concentrate for I.V. infusion 30 mg in 5 mL (Paclitaxel Actavis) Solution concentrate for I.V. infusion 100 mg in 16.7 mL (Paclitaxel Actavis) Solution concentrate for I.V. infusion 150 mg in 25 mL (Paclitaxel Actavis) Solution concentrate for I.V. infusion 300 mg in 50 mL (Paclitaxel Actavis) |
Paracetamol | Tablet 500 mg (APO-Paracetamol) |
Paroxetine | Tablet 20 mg (as hydrochloride) (Paroxetine-GA) |
Ramipril | Tablet 1.25 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril) Tablet 2.5 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril) Tablet 5 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril) Tablet 10 mg (APO-Ramipril, Chem mart Ramipril, Terry White Chemists Ramipril) |
Sodium Chloride | I.V. infusion 154 mmol per L, 1 L (B. Braun Australia Pty Ltd) |
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 (Pharmatel Fresenius Kabi Pty Limited) I.V. infusion containing approximately 131 mmol sodium (as lactate and chloride), 5 mmol potassium (as chloride), 2 mmol calcium (as chloride), |
Temazepam | Tablet 10 mg (APO-Temazepam) |
Alteration of Brands
Insulin Lispro | Injections (human analogue), cartridges, 100 units per mL, 3 mL, 5 From: Humalog Pen To: Humalog KwikPen |
Insulin Lispro with Insulin Lispro Protamine Suspension | Injections (human analogue), cartridges, 25 units-75 units per mL, 3 mL, 5 From: Humalog Mix25 Pen To: Humalog Mix25 KwikPen Injections (human analogue), cartridges, 50 units-50 units per mL, 3 mL, 5 From: Humalog Mix50 Pen To: Humalog Mix50 KwikPen |
Forms Deleted
Chorionic Gonadotrophin | Injection set containing 3 ampoules powder for injection 500 units and |
Glucose Indicator―Blood | Electrode strips, 100 (TrueSense) |
Brands Deleted
Bisacodyl | Suppositories 10 mg, 12 (Fleet Laxative Suppositories) |
Paracetamol | Tablet 500 mg (Parmol) |
SCHEDULE 1 ― PART 2
Listed Drug Added
Rivaroxaban |
Forms Added
Etanercept | Injection 50 mg in 1 mL single use injection pen, 4 |
Glucose Indicator―Blood | Electrode strips, 50 (MyGlucoHealth) |
Brands Added
Azithromycin | Tablet 500 mg (as dihydrate) (Azithromycin Sandoz) |
Cabergoline | Tablet 500 micrograms (Tinexa) |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg |
Escitalopram | Tablet 10 mg (as oxalate) (Lexam 10) Tablet 20 mg (as oxalate) (Lexam 20) |
Morphine | Tablet containing morphine sulfate 10 mg (controlled release) (Momex SR 10) Tablet containing morphine sulfate 30 mg (controlled release) (Momex SR 30) Tablet containing morphine sulfate 60 mg (controlled release) (Momex SR 60) Tablet containing morphine sulfate 100 mg (controlled release) |
Paracetamol | Tablet 500 mg (APO-Paracetamol) |
Temazepam | Tablet 10 mg (APO-Temazepam) |
Listed Drug Deleted
Chorionic Gonadotrophin |
Form Deleted
Glucose Indicator―Blood | Electrode strips, 100 (TrueSense) |
Brand Deleted
Paracetamol | Tablet 500 mg (Parmol) |
SCHEDULE 2 ― PART 1
Listed Drug Added
Hypromellose |
Brand Added
Temazepam | Tablet 10 mg (APO-Temazepam) |
Brand Deleted
Bisacodyl | Suppositories 10 mg, 12 (Fleet Laxative Suppositories) |
SCHEDULE 2 ― PART 2
Listed Drug Added
Hypromellose |
Brand Added
Temazepam | Tablet 10 mg (APO-Temazepam) |
Brand Deleted
Bisacodyl | Suppositories 10 mg, 12 (Fleet Laxative Suppositories) |
SCHEDULE 3 ― PART 1
Forms Added
Glucose | I.V. infusion 139 mmol (anhydrous) per 500 mL, 500 mL |
Sodium Chloride | I.V. infusion 77 mmol per 500 mL, 500 mL |
Brands Added
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) (APO-Amoxycillin/Clavulanic Acid 500/125) Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL (Curam) Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL |
Codeine with Paracetamol | Tablet containing codeine phosphate 30 mg with paracetamol 500 mg |
Glucose | I.V. infusion 278 mmol (anhydrous) per L, 1 L (B. Braun Australia Pty Ltd) |
Morphine | Tablet containing morphine sulfate 10 mg (controlled release) (Momex SR 10) Tablet containing morphine sulfate 30 mg (controlled release) (Momex SR 30) Tablet containing morphine sulfate 60 mg (controlled release) (Momex SR 60) Tablet containing morphine sulfate 100 mg (controlled release) |
Paracetamol | Tablet 500 mg (APO-Paracetamol) |
Sodium Chloride | I.V. infusion 154 mmol per L, 1 L (B. Braun Australia Pty Ltd) |
Temazepam | Tablet 10 mg (APO-Temazepam) |
Brand Deleted
Paracetamol | Tablet 500 mg (Parmol) |
SCHEDULE 3 ― PART 2
Brand Added
Paracetamol | Tablet 500 mg (APO-Paracetamol) |
Brand Deleted
Paracetamol | Tablet 500 mg (Parmol) |