EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 4)
PB 14 of 2013
Purpose
The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88, and 101 of the National Health Act 1953 (the Act) is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.
PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantity and pack quantity, and whether the pharmaceutical benefit is to be available only under special arrangements).
Authority
PB 71 of 2012 exercises numerous provisions in Part VII of the Act, as set out below:
Pharmaceutical benefits listed on the PBS
Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies. A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)). Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug. A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB). The Minister may also determine a brand of a pharmaceutical item (subsection 85(6)). The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)). Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.
Prescribing pharmaceutical benefits
Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit. Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).
Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.
Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion. Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated. The maximum quantities and repeats may be determined for all purposes or for particular purposes.
Supplying pharmaceutical benefits
Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the PBAC has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.
Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.
Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).
Variation and revocation of subsection 85(2) declaration
Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation. Advice from the Pharmaceutical Benefits Advisory Committee (PBAC) is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).
Changes to PB 71 of 2012 made by this instrument
Schedule 1 to this instrument provides for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status. These changes are summarised, by subject matter, in the Attachment.
Consultation
The involvement of interested parties through the membership of PBAC constitutes a formal and ongoing process of consultation. PBAC is an independent expert body established by section 100A of the Act 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the PBS, 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.
Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings. This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, and agreement to final listing details.
Medical and pharmacy professional groups, key stakeholder groups representing oncologists and pharmacists, State and Territory health departments, as well as the Department of Human Services and the Medical Software Industry Association, were also consulted throughout the process of developing all legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy.
General
A provision by provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 April 2013.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2013 (No. 4)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 4) and may also be cited as PB 14 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2013.
Section 3 Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
This section provides that Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
Schedule 1 Amendments
The amendments in Schedule 1 involve additions, deletions and changes to forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities and section 100 only status. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drugs Added
Boceprevir |
Rotigotine |
Sitagliptin with simvastatin |
Telaprevir |
Forms Added
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 100 micrograms-20 micrograms and 7 inert tablets |
Forms Deleted
Amlodipine | Tablet 5 mg (as maleate) |
Brands Added
Amlodipine | Tablet 5 mg (as besylate) (Amlo 5) |
Donepezil | Tablet containing donepezil hydrochloride 5 mg (APO-Donepezil; Arazil; Aridon 5; Chem mart Donepezil; Donepezil-DRLA; Donepezil-GA; Donepezil generichealth; Donepezil RBX; Donepezil Sandoz; Donepezil-Synthon; STADA Donepezil; Terry White Chemists Donepezil) Tablet containing donepezil hydrochloride 10 mg (Arazil; APO-Donepezil; Aridon 10; Chem mart Donepezil; Donepezil-DRLA; Donepezil-GA; Donepezil generichealth; Donepezil RBX; Donepezil Sandoz; Donepezil-Synthon; STADA Donepezil; Terry White Chemists Donepezil) |
Duloxetine | Capsule 30 mg (as hydrochloride) (Andepra; APO-Duloxetine; Chem mart Duloxetine; Terry White Chemists Duloxetine) Capsule 60 mg (as hydrochloride) (Andepra; APO-Duloxetine; Chem mart Duloxetine; Terry White Chemists Duloxetine) |
Epirubicin | Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL (Epirubicin SZ) |
Irbesartan | Tablet 75 mg (Abisart; APO-Irbesartan; Chem mart Irbesartan; Irbesartan-DRLA; Irbesartan-GA; Irbesartan RBX; Irbesartan Sandoz; Irbesartan Winthrop; Irbesat; Karbesat 75; Terry White Chemists Irbesartan) Tablet 150 mg (Abisart; APO-Irbesartan; Chem mart Irbesartan; Irbesartan-DRLA; Irbesartan-GA; Irbesartan RBX; Irbesartan Sandoz; Irbesartan Winthrop; Irbesat; Karbesat 150; Terry White Chemists Irbesartan) Tablet 300 mg (Abisart; APO-Irbesartan; Chem mart Irbesartan; Irbesartan-DRLA; Irbesartan-GA; Irbesartan RBX; Irbesartan Sandoz; Irbesartan Winthrop; Irbesat; Karbesat 300; Terry White Chemists Irbesartan) |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg (Abisart HCT 150/12.5; APO-Irbesartan HCTZ; Chem mart Irbesartan HCTZ; Irbesartan/HCT Sandoz; Irbesartan HCT Winthrop 150/12.5; Irbesartan HCTZ-GA 150/12.5; Irbesartan/HCTZ RBX 150/12.5; Irbesatzide 150/12.5; KSART HCT 150/12.5; STADA Irbesartan HCT 150/12.5; Terry White Chemists Irbesartan HCTZ) Tablet 300 mg-12.5 mg (Abisart HCT 300/12.5; APO-Irbesartan HCTZ; Chem mart Irbesartan HCTZ; Irbesartan/HCT Sandoz; Irbesartan HCT Winthrop 300/12.5; Irbesartan HCTZ-GA 300/12.5; Irbesartan/HCTZ RBX 300/12.5; Irbesatzide 300/12.5; KSART HCT 300/12.5; STADA Irbesartan HCT 300/12.5; Terry White Chemists Irbesartan HCTZ) Tablet 300 mg-25 mg (Abisart HCT 300/25; APO- Irbesartan HCTZ; Chem mart Irbesartan HCTZ; Irbesartan/HCT Sandoz; Irbesartan HCT Winthrop 300/25; Irbesartan HCTZ-GA 300/25; Irbesartan/HCTZ RBX 300/25; Irbesatzide 300/25; KSART HCT 300/25; STADA Irbesartan HCT 300/25; Terry White Chemists Irbesartan HCTZ) |
Irinotecan | I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL (Irinotecan SZ) |
Interferon Beta-1b | Injection set including 1 vial powder for injection 8,000,000 I.U. (250 micrograms) and solvent (Extavia) |
Lercanidipine | Tablet containing lercanidipine hydrochloride 10 mg (Lercanidipine GH) |
Levonorgestrel with Ethinyloestradiol | Pack containing 21 tablets 150 micrograms-30 micrograms and 7 inert tablets (Femme-Tab ED 30/150) |
Mometasone | Lotion containing mometasone furoate 1 mg per g, 30 mL (Zatamil) |
Ondansetron | I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL (Ondansetron Kabi) |
Oxaliplatin | Solution concentrate for I.V. infusion 100 mg in 20 mL (Oxaliplatin SZ) |
Pamidronic Acid | Concentrated injection containing disodium pamidronate 30 mg in 10 mL (Pamidronate Strides) |
Sumatriptan | Tablet 50 mg (as succinate) (APO-Sumatriptan; Chem mart Sumatriptan; Terry White Chemists Sumatriptan) [these existing brands are now listed with a pack quantity of 2 and 4] |
Thiamine | Tablet containing thiamine hydrochloride 100 mg (Betavit) |
Tropisetron | I.V. injection 5 mg (as hydrochloride) in 5 mL (Tropisetron-AFT) |
Brands Deleted
Alendronic Acid | Tablet 70 mg (as alendronate sodium) (Alendronate Pfizer) |
Amoxycillin | Capsule 250 mg (as trihydrate) (Amoxycillin-PS) |
Anastrozole | Tablet 1 mg (Anastrozole-PS) |
Atenolol | Tablet 50 mg (Atenolol-PS) |
Azathioprine | Tablet 50 mg (Azathioprine-PS) |
Bisoprolol | Tablet containing bisoprolol fumarate 2.5 mg (Bisoprolol Pfizer) |
Calcitriol | Capsule 0.25 microgram (Calcitriol-PS) |
Cephalexin | Capsule 250 mg (anhydrous) (Cephalexin-PS) |
Ciprofloxacin | Tablet 500 mg (as hydrochloride) (Ciprofloxacin-PS) |
Citalopram | Tablet 20 mg (as hydrobromide) (Citalopram Pfizer) |
Clarithromycin | Tablet 250 mg (Clarithromycin-PS) |
Clopidogrel | Tablet 75 mg (as besilate) (Clopidogrel-PS) |
Cyproterone | Tablet containing cyproterone acetate 50 mg (Cyproterone-PS) |
Diltiazem | Tablet containing diltiazem hydrochloride 60 mg (Diltiazem-PS) |
Enalapril | Tablet containing enalapril maleate 5 mg (Enalapril-PS) |
Famotidine | Tablet 20 mg (Famotidine-PS) |
Fluoxetine | Capsule 20 mg (as hydrochloride) (Fluoxetine-PS) |
Flutamide | Tablet 250 mg (Eulexin) |
Frusemide | Tablet 20 mg (Frusemide-PS) |
Indapamide | Tablet containing indapamide hemihydrate 2.5 mg (Indapamide-PS) |
Isosorbide Mononitrate | Tablet 60 mg (sustained release) (Isosorbide-PS) |
Isotretinoin | Capsule 20 mg (Isotretinoin-PS) |
Lamotrigine | Tablet 25 mg (Lamotrigine-PS) |
Letrozole | Tablet 2.5 mg (Letara) |
Levetiracetam | Tablet 250 mg (Levetiracetam Pfizer) |
Lisinopril | Tablet 5 mg (Lisinopril-PS) |
Meloxicam | Tablet 7.5 mg (Meloxicam-PS) |
Metformin | Tablet containing metformin hydrochloride 500 mg (Metformin Pfizer) |
Mirtazapine | Tablet 15 mg (Mirtazapine Pfizer) |
Moclobemide | Tablet 150 mg (Moclobemide-PS) |
Norfloxacin | Tablet 400 mg (Norfloxacin-PS) |
Olanzapine | Tablet 2.5 mg (Olanzapine-PS) |
Omeprazole | Tablet 20 mg (Omeprazole-PS) |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) (Ondansetron Tabs Pfizer) |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Pantoprazole-PS) |
Paroxetine | Tablet 20 mg (as hydrochloride) (Paroxetine-PS) |
Pioglitazone | Tablet 15 mg (as hydrochloride) (Pioglitazone Pfizer) |
Pravastatin | Tablet containing pravastatin sodium 10 mg (Pravastatin-PS) |
Prochlorperazine | Tablet containing prochlorperazine maleate 5 mg (Prochlorperazine-PS) |
Quetiapine | Tablet 25 mg (as fumarate) (Quetiapine Pfizer) |
Rabeprazole | Tablet containing rabeprazole sodium 10 mg (enteric coated) |
Ramipril | Tablet 1.25 mg (Ramipril Tabs Pfizer) |
Ranitidine | Tablet 150 mg (as hydrochloride) (Ranitidine-PS) |
Risperidone | Tablet 0.5 mg (Risperidone Pfizer) |
Roxithromycin | Tablet 150 mg (Roxithromycin-PS) |
Simvastatin | Tablet 10 mg (Simvastatin Pfizer) |
Sumatriptan | Tablet 50 mg (as succinate) (Sumatriptan-PS) |
Thiamine | Tablet containing thiamine hydrochloride 100 mg (Betamin) |
Valaciclovir | Tablet 500 mg (as hydrochloride) (Valaciclovir Pfizer; Valvala) |
Alteration of Responsible Person
Listed Drug | Form | Brand | Responsible Person |
Albendazole | Tablet 200 mg Tablet 400 mg | Zentel Eskazole | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Amoxycillin | Capsule 250 mg (as trihydrate) Powder for paediatric oral drops 100 mg (as trihydrate) per mL, 20 mL Powder for oral suspension 125 mg (as trihydrate) per 5 mL, 100 mL | Amoxil Amoxil Amoxil | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Amoxycillin with Clavulanic Acid | Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate) Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL | Augmentin Duo Augmentin Duo forte Augmentin Augmentin Duo 400 | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Atovaquone | Oral suspension 750 mg per 5 mL, 210 mL | Wellvone | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Bupropion | Tablet containing bupropion hydrochloride 150 mg (sustained release) | Zyban | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Cefuroxime | Tablet 250 mg (as axetil) | Zinnat | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Lamivudine | Tablet 100 mg Oral solution 5 mg per mL, 240 mL | Zeffix Zeffix | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Lamotrigine | Tablet 5 mg Tablet 25 mg Tablet 50 mg Tablet 100 mg Tablet 200 mg | Lamictal Lamictal Lamictal Lamictal Lamictal | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Lithium | Tablet containing lithium carbonate 450 mg (slow release) | Quilonum SR | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Mesalazine | Tablet 250 mg (enteric coated) | Mesasal | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Naratriptan | Tablet 2.5 mg (as hydrochloride) | Naramig | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Ondansetron | Tablet 4 mg (as hydrochloride dihydrate) Tablet 8 mg (as hydrochloride dihydrate) Wafer 4 mg Syrup 4 mg (as hydrochloride dihydrate) per 5 mL, 50 mL I.V. injection 4 mg (as hydrochloride dihydrate) in 2 mL I.V. injection 8 mg (as hydrochloride dihydrate) in 4 mL | Zofran Zofran Zofran Zydis Zofran Zofran | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Paroxetine | Tablet 20 mg (as hydrochloride) | Aropax | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Pyrimethamine | Tablet 25 mg | Daraprim | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Ranitidine | Tablet 150 mg (as hydrochloride) Tablet, effervescent, 150 mg (as hydrochloride) Tablet 300 mg (as hydrochloride) Syrup 150 mg (as hydrochloride) per 10 mL, 300 mL | Zantac Zantac Zantac Zantac Syrup | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Sumatriptan | Tablet 50 mg (as succinate)
| Imigran
| From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (LN) |
Tablet (fast disintegrating) 50 mg (as succinate) Nasal spray 20 mg in 0.1 mL single dose unit | Imigran FDT Imigran | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) | |
Ticarcillin with Clavulanic Acid | Powder for injection containing ticarcillin 3 g (as sodium) with 100 mg clavulanic acid (as potassium clavulanate) | Timentin | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Valaciclovir | Tablet 500 mg (as hydrochloride) | Valtrex | From: GlaxoSmithKline Australia Pty Ltd (GK) To: Aspen Pharmacare Australia Pty Limited (AS) |
Addition of Responsible Person Code
Ego Pharmaceuticals Proprietary Limited [EO]
Alteration of Circumstances
Listed Drug | Alteration |
Ciprofloxacin | Circumstances amended to require the involvement of an ophthalmologist in the prescribing of ciprofloxacin eye drops |
Ofloxacin | Circumstances amended to require the involvement of an ophthalmologist in the prescribing of ofloxacin eye drops |
Ribavirin and Peginterferon Alfa-2a | Circumstances amended in relation to the treatment of chronic genotype 1 hepatitis C infection |
Ribavirin and Peginterferon Alfa-2b | Circumstances amended in relation to the treatment of chronic genotype 1 hepatitis C infection |
Strontium | Availability extended to patients regardless of gender |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 4)
(PB 14 of 2013)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 4) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands. It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantities, pack quantities and whether the pharmaceutical benefit is to be available only under special arrangements).
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing