EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY)
SPECIAL ARRANGEMENT AMENDMENT (AUGUST UPDATE) INSTRUMENT 2024
PB 80 of 2024
Purpose
This is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (August Update) Instrument 2024 (PB 80 of 2024) (this 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 (Efficient Funding of Chemotherapy) Special Arrangement 2024 (PB 31 of 2024) (the Special Arrangement) to make changes relating to the Efficient Funding of Chemotherapy.
The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (‘chemotherapy pharmaceutical benefits’) to eligible patients being treated for cancer, to reflect the 2010 Budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’. The Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (‘related pharmaceutical benefits’) at certain public hospitals.
This Instrument makes amendments to the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024) which commences on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Schedule 1 to this Instrument provides for the addition of a form of the listed drug atezolizumab, the deletion of a form of the listed drugs folinic acid and mitrozantrone, and the alteration of circumstances in which a prescription may be written for the listed drugs avelumab, durvalumab, and nivolumab under the Special Arrangement.
These changes are summarised, by subject matter, in the Attachment.
Authority
Subsection 100(1) of 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).
Consultations
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 Pharmaceutical Benefits Advisory Committee (PBAC).
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 as pharmaceutical benefits. Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
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 these 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.
Pharmaceutical companies are consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process 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 has already taken place.
General
A provision-by-provision description of this instrument is contained in the Attachment.
This Instrument commences on 1 August 2024.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT (AUGUST UPDATE) INSTRUMENT 2024
Section 1 Name of Instrument
This section provides that the name of the Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (August Update) Instrument 2024 and may also be cited as PB 80 of 2024.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 2024.
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 addition and deletion of forms of listed drugs, and the alteration of circumstances in which a prescription may be written for listed drugs under the Special Arrangement. These changes are summarised below.
SUMMARY OF CHANGES TO THE EFFICIENT FUNDING OF CHEMOTHERAPY PROGRAM MADE BY THIS INSTRUMENT
Form Added
Listed Drug | Form |
Atezolizumab | Solution for subcutaneous injection 1875 mg in 15 mL |
Forms Deleted
Listed Drug | Form |
Folinic acid | Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL |
Mitozantrone | Injection 25 mg (as hydrochloride) in 12.5 mL |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
|
Avelumab | Nivolumab |
Durvalumab |
|
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Nivolumab | Approved Product Information/Australian Product Information/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 |
Atezolizumab Avelumab Durvalumab Nivolumab | World Health Organisation (WHO) / Eastern Cooperative Oncology Group (ECOG) performance status grading system 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. Performance status quantifies the general well‑being and ability to perform activities of daily life of a patient affected by cancer. The grading runs in whole numbers from 0 to 5, with grade 0 representing perfect health and 5 representing death. It is also known as the Eastern Cooperative Oncology Group (ECOG) score, or as the Zubrod score. | Medical text books and literature. Scientific journals that reference: Oken MM et al. 1982. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655 The ECOG-ACRIN Cancer Research Group publishes the scale on the following website: https://ecog-acrin.org/resources/ecog-performance-status/ |
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (August Update) Instrument 2024
(PB 80 of 2024)
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 purpose of this Legislative Instrument, made under subsection 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (PB 31 of 2024) (the Special Arrangement) to make changes relating to the Efficient Funding of Chemotherapy.
The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (‘chemotherapy pharmaceutical benefits’) to eligible patients being treated for cancer, to reflect the 2010 Budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’. The Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (‘related pharmaceutical benefits’) at certain public hospitals.
This Instrument provides for amendments to the Special Arrangement to ensure that the Special Arrangement accurately reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (the Listing Instrument), made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act, which commences on the same day.
Human Rights Implications
This Instrument engages Articles 9 and 12 of the International Covenant on Economic Social and Cultural Rights (ICESCR), specifically the rights to social security and health.
The Right to Social Security
The right to social security is contained in Article 9 of the ICESCR. It requires that a country must, within its maximum available resources, ensure access to a social security scheme that provides a minimum essential level of benefits to all individuals and families that will enable them to acquire at least essential health care. Countries are obliged to demonstrate that every effort has been made to use all resources that are at their disposal in an effort to satisfy, as a matter of priority, this minimum obligation.
The Right to Health
The right to the enjoyment of the highest attainable standard of physical and mental health is contained in Article 12(1) of the ICESCR. The UN Committee on Economic Social and Cultural Rights (the Committee) has stated that the right to health is not a right for each individual to be healthy, but is a right to a system of health protection which provides equality of opportunity for people to enjoy the highest attainable level of health.
The Committee reports that the ‘highest attainable standard of health’ takes into account the country’s available resources. This right may be understood as a right of access to a variety of public health and health care facilities, goods, services, programs, and conditions necessary for the realisation of the highest attainable standard of health.
Analysis
This Instrument advances the right to health and the right to social security by ensuring that the amendments to the Listing Instrument, that affect the pharmaceutical benefits that may be supplied under the Special Arrangement, are made concurrently. This Instrument provides for the addition of a form of the listed drug atezolizumab, and the deletion of forms of the listed drugs folinic acid and mitrozantrone for the Special Arrangement.
The Listing Instrument 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. The PBS is a benefit scheme which assists with advancement of these human rights 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.
When a sponsor submits a request to delist a drug from the PBS, subsection 101(4AAB) of the National Health Act 1953 requires that the Minister or their delegate obtain advice from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent and expert advisory body, before varying or revoking declarations under subsection 85(2) so as to delist the drug. In these instances, one of the matters which the PBAC provides advice on is whether the delisting of a drug will result in an unmet clinical need for patients. The PBAC also considers whether the delisting of a form of a drug will result in an unmet clinical need for patients.
Written advice from the PBAC is tabled with the monthly amendments to the Listing Instrument. An unmet clinical need would arise when a currently treated patient population would be left without treatment options once a delisting occurs. Alternative treatment options could include using a different: form, strength or drug. The PBAC considered the delisting of drugs and forms of drugs in the abovementioned instruments, would not result in an unmet clinical need, except where indicated for a particular drug or form of drug below. Where the PBAC has identified an unmet clinical need, a Supply Only period has been/will be instituted as outlined below to allow opportunity for patients to transition to an alternative treatment option. The delisting of these items will not affect access to the drugs (or an alternative treatment if required), as affected patients will be able to access alternative medicines through the PBS, and the delisting is unlikely to have an effect on the amount patients pay for those drugs, as co-payment amounts are capped, ensuring their rights to social security are maintained. From 1 January 2024, these amounts are $31.60 for general patients and $7.70 for concession card holders.
The drug folinic acid in the form injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL (Leucovorin Calcium (Pfizer Australia Pty Ltd)) was requested to be delisted from the PBS Schedule by the sponsor. The PBAC noted that this product is an essential medicine and that the alternative product is currently in short supply. The PBAC advised the delisting of this product may result in an unmet clinical need if a stable supply of the alternative product was not available.
The drug mitozantrone in the form injection 25 mg (as hydrochloride) in 12.5 mL (Onkotrone) was requested to be delisted from the PBS Schedule by the sponsor. The PBAC noted the low number of services in the last financial year. The PBAC advised the delisting of this product would not result in an unmet clinical need.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Nikolai Tsyganov
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care