EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2019 (No. 3)
PB 17 of 2019
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 Pharmaceutical Benefits Advisory Committee (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 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 the PBAC constitutes a formal and ongoing process of consultation. The 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. The 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. 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 April 2019.
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 2019 (No. 3)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2019 (No. 3) and may also be cited as PB 17 of 2019.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2019.
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
Safinamide |
Sofosbuvir with velpatasvir and voxilaprevir |
Forms Added
Aciclovir | Eye ointment 30 mg per g, 4.5 g (Acivision) |
Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine | Oral powder 400 g (PKU Start) |
Follitropin alfa with lutropin alfa | Injection 900 I.U. - 450 I.U. in 1.44 mL multi-dose cartridge |
Levodopa with carbidopa | Tablet (modified release) 200 mg-50 mg |
Tablet 250 mg-25 mg (USP) | |
Riluzole | Oral suspension 50 mg per 10 mL, 300 mL |
Brands Added
Atazanavir | Capsule 200 mg (as sulfate) (Atazanavir Mylan) |
Capsule 300 mg (as sulfate) (Atazanavir Mylan) | |
Eplerenone | Tablet 25 mg (APO-Eplerenone) |
Tablet 50 mg (APO-Eplerenone) | |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) |
Tablet (enteric coated) 40 mg (as sodium sesquihydrate) | |
Salbutamol | Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 (Salbutamol Cipla) |
Nebuliser solution 5 mg (as sulfate) in 2.5 mL single dose units, 30 |
Brands Deleted
Capecitabine | Tablet 500 mg (Xeloda) |
Diazepam | Tablet 5 mg (Ranzepam) |
Epirubicin | Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL (Epirubicin SZ) |
Ranitidine | Tablet 150 mg (as hydrochloride) (Ulcaid) |
Topiramate | Tablet 100 mg (Topiramate GH) |
Valsartan | Tablet 40 mg (APO-Valsartan) |
Tablet 80 mg (APO-Valsartan) | |
Tablet 160 mg (APO-Valsartan) | |
Tablet 320 mg (APO-Valsartan) |
Alteration of Manner of Administration
Listed Drug | Form | From | To |
Dexamethasone | Intravitreal injection 700 micrograms | Injection | Implantation |
Additional Pack Quantity
Listed Drug | Form | Brand | Maximum | Pack | ||
Risperidone | Tablet 0.5 mg | APO-Risperidone | 60 | 60 | ||
Alteration of Responsible Person Code
Listed Drug | Form | Brand Name | Responsible Person |
Oxybutynin | Transdermal patches | Oxytrol | From: GN To: TT |
Risedronic | Tablet containing risedronate sodium | Actonel | From: UA To: TT |
Tablet containing risedronate sodium | Actonel | From: UA To: TT | |
Tablet (enteric coated) containing risedronate sodium 35 mg | Actonel EC | From: UA To: TT | |
Tablet containing risedronate sodium | Actonel Once-a-Month | From: UA To: TT | |
ATELVIA ONCE-A-MONTH | From: GN To: TU |
Addition of Responsible Person
Theramex Australia Pty Ltd (TT, TU) |
Alteration of Circumstances
Abatacept |
Adalimumab |
Adrenaline (epinephrine) |
Armodafinil |
Baricitinib |
Brentuximab vedotin |
Certolizumab pegol |
Etanercept |
Filgrastim |
Golimumab |
Guselkumab |
Imatinib |
Modafinil |
Nilotinib |
Riluzole |
Rituximab |
Somatropin |
Tildrakizumab |
Tocilizumab |
Tofacitinib |
Venetoclax |
Document incorporated by reference
Listed Drug/s | Document incorporated | Document access |
Guselkumab | Psoriasis Area Severity Index (PASI) calculation form. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The PASI is a widely used tool that enables measurement of the severity and extent of baseline and response of therapy in psoriasis. | The PASI calculation form is available for download for free from the Department of Human Services website
|
Alteration of general statement for drugs for the treatment of hepatitis C
New listed drug sofosbuvir with velpatasvir and voxilaprevir added to regimens applicable to patients who are treatment experienced. |
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 2019 (No. 3)
(PB 17 of 2019)
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 2019 (No. 3) 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.
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.
Thea Daniel
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health