EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2018 (No. 6)
PB 36 of 2018
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 (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, number of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).
Authority
This Instrument exercises various powers 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). Subsection 85(6) provides that the Minister may determine a brand of a pharmaceutical item.
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.
Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.
Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.
Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions.
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
Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.
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, and the circumstances for prescribing various pharmaceutical benefits (including authority requirements) and equivalent brands. 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 to Australians 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. In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015. 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, guarantee of supply and agreement to final listing details.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.
General
A provision-by-provision description of this Instrument is contained in the Attachment.
This Instrument commences on 1 June 2018.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2018 (No. 6)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 6) and may also be cited as PB 36 of 2018.
Section 2 Commencement
This section provides that this Instrument commences on 1 June 2018.
Section 3 Amendment of 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 drugs, forms, brands, responsible person codes, the circumstances for prescribing various pharmaceutical benefits (including authority requirements) and equivalent brands. These changes are summarised below.
SUMMARY OF CHANGES
Listed Drugs Added
Cabozantinib |
Dulaglutide |
Fluticasone furoate with umeclidinium and vilanterol |
Nusinersen |
Listed Drugs Deleted
Daclizumab |
Didanosine |
Interferon alfa-2b |
Stavudine |
Forms Added
Golimumab | Injection 100 mg in 1 mL single use pre-filled pen |
Forms Deleted
Lamivudine | Oral solution 5 mg per mL, 240 mL |
Olanzapine | Tablet 2.5 mg (as benzoate) |
Brands Added
Acamprosate | Tablet (enteric coated) containing acamprosate calcium 333 mg (APO-Acamprosate) |
Adrenaline | I.M. injection 150 micrograms in 0.3 mL single dose syringe auto‑injector (Adrenaline Jr Mylan) I.M. injection 300 micrograms in 0.3 mL single dose syringe auto‑injector (Adrenaline Mylan) |
Amino acids-synthetic, formula | Oral powder 400 g (Neocate Junior Vanilla) |
Buprenorphine | Transdermal patch 5 mg (Bupredermal) Transdermal patch 10 mg (Bupredermal) Transdermal patch 20 mg (Bupredermal) |
Cyclophosphamide | Tablet 50 mg (Cyclonex) |
Dosulepin | Capsule containing dosulepin hydrochloride 25 mg (Dosulepin Mylan) Tablet containing dosulepin hydrochloride 75 mg (Dosulepin Mylan) |
Dicloxacillin | Capsule 250 mg (as sodium) (Dicloxacillin Mylan 250) Capsule 500 mg (as sodium) (Dicloxacillin Mylan 500) |
Enoxaparin | Injection containing enoxaparin sodium 20 mg (2,000 I.U. anti-Xa) in 0.2 mL pre-filled syringe (Enoxaparin Winthrop) Injection containing enoxaparin sodium 40 mg (4,000 I.U. anti-Xa) in 0.4 mL pre-filled syringe (Enoxaparin Winthrop) Injection containing enoxaparin sodium 60 mg (6,000 I.U. anti-Xa) in 0.6 mL pre-filled syringe (Enoxaparin Winthrop) Injection containing enoxaparin sodium 80 mg (8,000 I.U. anti-Xa) in 0.8 mL pre-filled syringe (Enoxaparin Winthrop) Injection containing enoxaparin sodium 100 mg (10,000 I.U. anti-Xa) in 1 mL pre-filled syringe (Enoxaparin Winthrop) |
Everolimus | Tablet 5 mg (Everolimus Sandoz) Tablet 10 mg (Everolimus Sandoz) |
Ezetimibe | Tablet 10 mg (Zient 10mg) |
Ezetimibe and rosuvastatin | Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 5 mg (as calcium) (Ezalo Composite Pack 10mg+5mg) Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 10 mg (as calcium) (Ezalo Composite Pack 10mg+10mg) Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 20 mg (as calcium) (Ezalo Composite Pack 10mg+20mg) Pack containing 30 tablets ezetimibe 10 mg and 30 tablets rosuvastatin 40 mg (as calcium) (Ezalo Composite Pack 10mg+40mg) |
Ezetimibe with simvastatin | Tablet 10 mg-10 mg (Zeklen 10/10 mg) |
| Tablet 10 mg-20 mg (Zeklen 10/20 mg) |
| Tablet 10 mg-40 mg (Zeklen 10/40 mg) |
| Tablet 10 mg-80 mg (Zeklen 10/80 mg) |
Hydrocortisone | Tablet 4 mg (Hydrortisone Mylan 4) Tablet 20 mg (Hydrortisone Mylan 20) |
Irbesartan | Tablet 75 mg (AVSARTAN) Tablet 150 mg (AVSARTAN) Tablet 300 mg (AVSARTAN) |
Irbesartan with Hydrochlorothiazide | Tablet 150 mg-12.5 mg (AVSARTAN HCT 150/12.5) Tablet 300 mg-12.5 mg (AVSARTAN HCT 300/12.5) Tablet 300 mg-25 mg (AVSARTAN HCT 300/25) |
Lincomycin | Injection 600 mg (as hydrochloride monohydrate) in 2 mL (LINCOMYCIN SXP) |
Moxonidine | Tablet 200 micrograms (Moxonidine MYL) Tablet 400 micrograms (Moxonidine MYL) |
Tobramycin | Solution for inhalation 300 mg in 5 mL (Tobramycin WKT) |
Brands Deleted
Aciclovir | Tablet 200 mg (Zovirax 200 mg) |
Alprazolam | Tablet 250 micrograms (Alprax 0.25) |
Amino acids-synthetic, formula | Oral powder 400 g (Neocate Advance Vanilla) |
Celecoxib | Capsule 100 mg (Celecoxib RBX) Capsule 200 mg (Celecoxib RBX) |
Cyclophosphamide | Tablet 50 mg (Cycloblastin) |
Donepezil | Tablet containing donepezil hydrochloride 5 mg (Donepezil generichealth) Tablet containing donepezil hydrochloride 10 mg (Donepezil generichealth) |
Hydroxychloroquine | Tablet containing hydroxychloroquine sulfate 200 mg (Hydroxychloroquine RBX) |
Metoclopramide | Tablet containing metoclopramide hydrochloride 10 mg (Metoclopramide RBX) |
Metoprolol | Tablet containing metoprolol tartrate 100 mg (Metoprolol RBX) |
Venlafaxine | Capsule (modified release) 150 mg (as hydrochloride) (Venla RBX) |
Deletion of Pack Quantity
Listed Drug | Form | Brand Name | Pack Quantity |
Alprazolam | Tablet 500 micrograms Tablet 1 mg | Alprax 0.5 Alprax 1 | 50 50 |
Alteration of Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person |
Rosuvastatin | Tablet 5 mg (as calcium) | Crosuva 5 | From: (ZP) To: (RW) |
| Tablet 10 mg (as calcium) | Crosuva 10 | From: (ZP) To: (RW) |
| Tablet 20 mg (as calcium) | Crosuva 20 | From: (ZP) To: (RW) |
| Tablet 40 mg (as calcium)
| Crosuva 40 | From: (ZP) To: (RW) |
Alteration of Responsible Person Name
From: Finox Biotech Australia (FX) | To: Gedeon Richter Australia Pty Ltd (FX) |
Alteration of Circumstances
Adalimumab |
Amlodipine with Atorvastatin |
Fenofibrate |
Gemfibrozil |
International Harmonisation of Australian Medicines Terminology
From | To |
Dothiepin | Dosulepin |
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 2018 (No. 6)
(PB 36 of 2018)
This 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 Instrument
The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2018 (No. 6) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) 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, schedule equivalence, maximum quantities, number of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).
Schedule 1 to this Instrument provides for additions, deletions and changes to drugs, forms, brands, schedule equivalence, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements), determined quantities, pack quantities, section 100 only status and prescriber bag only status.
The listed drugs: Daclizumab; Didanosine; Interferon alfa-2b; and Stavudine have been deleted at the request of the relevant responsible persons.
Human rights implications
This Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights 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. The pharmaceutical industry now has a nominee on the PBAC membership.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Lisa La Rance
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health