EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2020 (No. 7)
PB 67 of 2020
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 the addition of the listed drugs entrectinib, lorlatinib and stiripentol to the PBS and for the addition of forms of the listed drugs metformin and salbutamol. It also provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs budesonide with formoterol, crizotinib, escitalopram (for a specified brand only), incobotulinumtoxinA, olaparib, osimertinib and tocilizumab and for the alteration of authority requirements for select circumstances codes applicable to the listed drugs bevacizumab, blinatumomab, brentuximab vedotin, certolizumab pegol, golimumab, guselkumab, inotuzumab ozogamicin, risankizumab and tildrakizumab (seventeen circumstances codes in total).
Schedule 1 to this Instrument also provides for the following changes:
- the addition of 19 brands and deletion of 11 brands of existing pharmaceutical items;
- the deletion of a pack size of 1 existing brand of a pharmaceutical item;
- the alteration of responsible person codes for 24 existing brands of pharmaceutical items; and
- the deletion of 1 responsible person from the list of responsible persons.
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 August 2020.
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 2020 (No. 7)
Section 1 Name of Instrument
This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 7) and may also be cited as PB 67 of 2020.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 2020.
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 the addition of drugs, the addition of forms of drugs, the addition and deletion of brands, the deletion of a pack size for an existing brand, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the deletion of a responsible person code from the list of responsible persons, the alteration of authority requirements for select circumstances codes applicable to a number of drugs and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme. These changes are summarised below.
SUMMARY OF CHANGES TO THE PHARMACEUTICAL BENEFITS SCHEME
MADE BY THIS INSTRUMENT
Listed Drugs Added
Listed Drug |
Entrectinib |
Lorlatinib |
Stiripentol |
Forms Added
Listed Drug | Form |
Metformin | Tablet (prolonged release) containing metformin hydrochloride 500 mg |
Salbutamol | Pressurised inhalation 100 micrograms (as sulfate) per dose with dose counter, 200 doses (CFC-free formulation) |
Brands Added
Listed Drug | Form and Brand |
Atorvastatin | Tablet 10 mg (as calcium) (NOUMED ATORVASTATIN) |
| Tablet 20 mg (as calcium) (NOUMED ATORVASTATIN) |
| Tablet 40 mg (as calcium) (NOUMED ATORVASTATIN) |
| Tablet 80 mg (as calcium) (NOUMED ATORVASTATIN) |
Levodopa with carbidopa and entacapone | Tablet 50 mg-12.5 mg (as monohydrate)-200 mg (Lecteva) |
| Tablet 75 mg-18.75 mg (as monohydrate)-200 mg (Lecteva) |
| Tablet 100 mg-25 mg (as monohydrate)-200 mg (Lecteva) |
| Tablet 125 mg-31.25 mg (as monohydrate)-200 mg (Lecteva) |
| Tablet 150 mg-37.5 mg (as monohydrate)-200 mg (Lecteva) |
| Tablet 200 mg-50 mg (as monohydrate)-200 mg (Lecteva) |
Lurasidone | Tablet containing lurasidone hydrochloride 40 mg (Lurasidone Lupin) |
| Tablet containing lurasidone hydrochloride 80 mg (Lurasidone Lupin) |
Nitrofurantoin | Capsule 50 mg (APO-Nitrofurantoin) |
| Capsule 100 mg (APO-Nitrofurantoin) |
Pegfilgrastim | Injection 6 mg in 0.6 mL single use pre-filled syringe (Pelgraz) |
Pregabalin | Capsule 25 mg (Cipla Pregabalin) |
| Capsule 75 mg (Cipla Pregabalin) |
| Capsule 150 mg (Cipla Pregabalin) |
| Capsule 300 mg (Cipla Pregabalin) |
Brands Deleted
Listed Drug | Form and Brand |
Capecitabine | Tablet 150 mg (Capecitabine AN) |
| Tablet 500 mg (Capecitabine AN) |
Famciclovir | Tablet 250 mg (Famciclovir Sandoz, Famlo) |
| Tablet 500 mg (Famciclovir Sandoz) |
Mercaptopurine | Tablet containing mercaptopurine monohydrate 50 mg |
Montelukast | Tablet, chewable, 5 mg (as sodium) (Montelukast GH) |
Pantoprazole | Tablet (enteric coated) 20 mg (as sodium sesquihydrate) (Panto) |
| Tablet (enteric coated) 40 mg (as sodium sesquihydrate) (Panto) |
Paracetamol | Tablet 500 mg (Paracetamol Generic Health) |
Risperidone | Tablet 4 mg (Ozidal) |
Deletion of Pack Quantity
Listed Drug | Form | Brand Name | Pack Quantity |
Risperidone | Tablet 0.5 mg | APO-Risperidone | 20 |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
Electrolyte replacement, oral | Oral rehydration salts containing glucose monohydrate 3.56 g, sodium chloride 470 mg, potassium chloride 300 mg and sodium acid citrate 530 mg per sachet, 10 | O.R.S | From: AS To: AF |
Entacapone | Tablet 200 mg | Comtan | From: NV To: SZ |
Guanfacine | Tablet 1 mg (as hydrochloride) | Intuniv | From: ZI To: TK |
Tablet 2 mg (as hydrochloride) | Intuniv | From: ZI To: TK | |
Tablet 3 mg (as hydrochloride) | Intuniv | From: ZI To: TK | |
Tablet 4 mg (as hydrochloride) | Intuniv | From: ZI To: TK | |
Icatibant | Injection 30 mg (as acetate) in 3 mL single use pre-filled syringe | Firazyr | From: ZI To: TK |
Lanthanum | Tablet, chewable, 500 mg (as carbonate hydrate) | Fosrenol | From: ZI To: TK |
Tablet, chewable, 750 mg (as carbonate hydrate) | Fosrenol | From: ZI To: TK | |
Tablet, chewable, 1000 mg (as carbonate hydrate) | Fosrenol | From: ZI To: TK | |
Levodopa with carbidopa and entacapone | Tablet 50 mg-12.5 mg (as monohydrate)-200 mg | Stalevo 50/12.5/200mg | From: NV To: SZ |
Tablet 75 mg-18.75 mg (as monohydrate)-200 mg | Stalevo 75/18.75/200mg | From: NV To: SZ | |
Tablet 100 mg-25 mg (as monohydrate)-200 mg | Stalevo 100/25/200mg | From: NV To: SZ | |
Tablet 125 mg-31.25 mg (as monohydrate)-200 mg | Stalevo 125/31.25/200mg | From: NV To: SZ | |
Tablet 150 mg-37.5 mg (as monohydrate)-200 mg | Stalevo 150/37.5/200mg | From: NV To: SZ | |
Tablet 200 mg-50 mg (as monohydrate)-200 mg | Stalevo 200/50/200mg | From: NV To: SZ | |
Lisdexamfetamine | Capsule containing lisdexamfetamine dimesilate 20 mg | Vyvanse | From: ZI To: TK |
Capsule containing lisdexamfetamine dimesilate 30 mg | Vyvanse | From: ZI To: TK | |
Capsule containing lisdexamfetamine dimesilate 40 mg | Vyvanse | From: ZI To: TK | |
Capsule containing lisdexamfetamine dimesilate 50 mg | Vyvanse | From: ZI To: TK | |
Capsule containing lisdexamfetamine dimesilate 60 mg | Vyvanse | From: ZI To: TK | |
Capsule containing lisdexamfetamine dimesilate 70 mg | Vyvanse | From: ZI To: TK | |
Mesalazine | Tablet 1.2 g (prolonged release) | Mezavant | From: ZI To: TK |
Teduglutide | Powder for injection 5 mg with diluent | Revestive | From: ZI To: TK |
Deletion of Responsible Person Code
Responsible Person and Code |
Shire Australia Pty Limited (ZI) |
Alteration of Authority Requirements
Listed Drug | Circumstances Code | Authority Requirements (part of Circumstances; or Conditions) |
Bevacizumab | C9102 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Blinatumomab | C9369 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C9519 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C9936 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Brentuximab vedotin | C8736 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Certolizumab pegol | C10431 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C10459 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C10489 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C10507 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C10513 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Golimumab | C10461 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C10506 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
| C10515 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Guselkumab | C8877 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Inotuzumab ozogamicin | C9601 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Risankizumab | C9986 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Tildrakizumab | C8475 | From: Compliance with Written Authority Required procedures To: Compliance with Authority Required procedures |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Budesonide with formoterol |
Crizotinib |
Escitalopram (Escitalopram GH brand only) |
IncobotulinumtoxinA |
Olaparib |
Osimertinib |
Tocilizumab |
Document/s incorporated by reference
Listed Drug | Document incorporated | Document access |
Atomoxetine | Diagnostic and statistical manual of mental disorders (DSM-5 or DSM-V). 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 DSM-5/DSM-V is a widely used tool for the definition and classification of mental disorders. | The DSM-5 can be accessed at the National Library of Australia and state libraries of Victoria, New South Wales and South Australia. The DSM-5 can be accessed through other public libraries, which can be identified through the National Library's Trove online system, and Australian universities and tertiary colleges. |
Atomoxetine Tocilizumab | Therapeutic Goods Administration (TGA)-approved Product Information. 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. This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine. | TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0 |
Crizotinib Entrectinib Lorlatinib Sunitinib |
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status. 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 ECOG/WHO performance status is a standard medical diagnostic tool used to measure how cancer impacts a patient’s daily living abilities, by evaluating a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). |
The ECOG/WHO Performance Status is available for download for free from the ECOG-ACRIN Cancer Research Group website: https://ecog-acrin.org/resources/ecog-performance-status |
IncobotulinumtoxinA | The Modified Ashworth Scale (MAS). 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 MAS measures spasticity in patients with lesions of the Central Nervous System. | The MAS is available for download for free from the Shirley Ryan Ability Lab website: https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale |
Olaparib | The Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. 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 RECIST guidelines are a tool used widely for defining when tumours in cancer patients respond, stabilise and/or progress during treatment. | The RECIST guidelines are available for download for free from the RECIST Working Group website: https://recist.eortc.org/ |
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 2020 (No. 7)
(PB 67 of 2020)
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 2020 (No. 7) 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).
The amendments in Schedule 1 involve the addition of drugs, the addition of forms of drugs, the addition and deletion of brands, the deletion of a pack size for an existing brand, the alteration of responsible person codes for a number of brands of pharmaceutical benefits, the deletion of a responsible person code from the list of responsible persons, the alteration of authority requirements for select circumstances codes applicable to a number of drugs and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme.
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.
Nikolai Tsyganov
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health