EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT (OCTOBER UPDATE) INSTRUMENT 2021
PB 101 of 2021
Purpose
This is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (October Update) Instrument 2021 (PB 101 of 2021) (this Instrument). The purpose of this Instrument, made under subsection 100(2) of the Act, is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs Program.
The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Schedule 1 to this Instrument provides for the addition of forms of the listed drug darunavir, the addition of four brands of existing pharmaceutical items, the deletion of the listed drug lenograstim, the deletion of forms of the listed drugs efavirenz, lanreotide, and zoledronic acid, and the deletion of seven brands of pharmaceutical items from the Special Arrangement. It also provides for the alteration of a brand name for the listed drug mannitol, and the alteration of circumstances in which a prescription may be written for the supply of the listed drugs infliximab, pomalidomide, and teduglutide under the Special Arrangement. These changes are summarised, by subject matter, in the Attachment.
Authority
Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Consultation
The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.
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. In addition, an industry nominee has been appointed to the PBAC membership. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (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 were consulted throughout the process of changes to the listings on the PBS. This includes consultation through the PBAC process.
Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.
Details of this Instrument are set out in the Attachment.
This Instrument commences on 1 October 2021.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (OCTOBER UPDATE) INSTRUMENT 2021
Section 1 Name of Instrument
This section provides the name of this Instrument as the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (October Update) Instrument 2021 and may also be cited as PB 101 of 2021.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 2021.
Section 3 Authority
This section states that this instrument is made under subsection 100(2) of the National Health Act 1953.
Section 4 Schedules
Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.
Schedule 1 Amendments
The amendments in Schedule 1 involve the deletion of a listed drug, the addition and deletion of forms of listed drugs, the addition and deletion of brands, the alteration of a brand name, and the alteration of circumstances for prescribing various listed drugs available under the Special Arrangement. These changes are summarised below.
SUMMARY OF CHANGES TO THE HIGHLY SPECIALISED
DRUGS PROGRAM MADE BY THIS INSTRUMENT
Listed Drug Deleted
Listed Drug |
Lenograstim |
Forms Added
Listed Drug | Form |
Darunavir | Tablet 600 mg |
Tablet 800 mg |
Forms Deleted
Listed Drug | Form |
Efavirenz | Oral solution 30 mg per mL, 180 mL |
Lanreotide | Powder for suspension for injection 30 mg (as acetate) with diluent |
Zoledronic acid | Solution for I.V. infusion 4 mg (as monohydrate) in 100 mL |
Brands Added
Listed Drug | Form and Brand |
Deferasirox | Tablet 90 mg (Deferasirox ARX) |
Tablet 180 mg (Deferasirox ARX) | |
Tablet 360 mg (Deferasirox ARX) | |
Valaciclovir | Tablet 500 mg (as hydrochloride) (APX-Valaciclovir) |
Brands Deleted
Listed Drug | Form and Brand |
Adalimumab | Injection 20 mg in 0.4 mL pre-filled syringe (Humira) |
Injection 40 mg in 0.8 mL pre-filled pen (Humira) | |
Injection 40 mg in 0.8 mL pre-filled syringe (Humira) | |
Entecavir | Tablet 0.5 mg (as monohydrate) (Baraclude) |
Tablet 1 mg (as monohydrate) (Baraclude) | |
Valganciclovir | Tablet 450 mg (as hydrochloride) (Valcyte) |
Zoledronic acid | Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL |
Alteration of Brand Name
Listed Drug | Form | Brand Name |
Mannitol | Pack containing 280 capsules containing powder for inhalation 40 mg and 2 inhalers | From: bronchitol To: Bronchitol |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
|
Infliximab |
|
Pomalidomide |
|
Teduglutide |
|
Documents incorporated by reference
Listed Drug | Document incorporated | Document access |
Infliximab | Mayo clinic score and the partial Mayo clinic score. 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 Mayo clinic score and the partial Mayo clinic score (an abbreviated form of the Mayo clinic score) are standard medical diagnostic tools used to measure disease activity in Ulcerative Colitis through the evaluation of symptoms. | The Mayo clinic score and the partial Mayo clinic score are available to download for free from the Inflammatory Bowel Diseases Journal via the Oxford University Press website: https://academic.oup.com/ibdjournal/article/14/12/1660/4654949?login=true |
Infliximab | Paediatric Ulcerative Colitis Activity Index (PUCAI). 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 PUCAI is a standard medical diagnostic tool used to measure disease activity in children and adolescents with Ulcerative Colitis through the evaluation of symptoms. | The PUCAI is available for download for free from the Inflammatory Bowel Diseases Journal via the Oxford University Press website: https://academic.oup.com/ibdjournal/article/15/8/1218/4643533 |
Infliximab | 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 |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Highly Specialised Drugs Program)
Special Arrangement Amendment (October Update) Instrument 2021
(PB 101 of 2021)
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 purpose of this Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (PB 27 of 2021) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs Program.
The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving specialised treatment.
The amendments in Schedule 1 involve the deletion of a drug, the addition and deletion of forms of listed drugs, the addition and deletion of brands, the alteration of a brand name, and the alteration of circumstances for prescribing various listed drugs available under the Special Arrangement.
Human Rights Implications
This Instrument engages Article 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 Pharmaceutical Benefits Scheme (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 Instrument is compatible with human rights because it advances the protection of human rights.
David Laffan
Assistant Secretary
Pharmacy Branch
Technology Assessment and Access Division
Department of Health