EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)SPECIAL ARRANGEMENT AMENDMENT (DECEMBER UPDATE) INSTRUMENT 2025
PB 138 of 2025
Purpose
This is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (December Update) Instrument 2025 (PB 138 of 2025) (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 (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 (HSD) Program.
The amendments made by this Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024), and amendments to that instrument, are made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Schedule 1 to this Instrument provides for the deletion of transitional arrangements relating to the transfer of the combination chemotherapy drugs nivolumab with relatlimab (Opdualag) and daunorubicin with cytarabine (Vyxeos) from the HSD Program to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (EFC Program), which occurred on 1 December 2024.
It also provides for the addition of a form of the listed drug ocrelizumab, the addition of a brand of the listed drug apomorphine, the deletion of a brand of the listed drug adalimumab, and the alteration of circumstances in which a prescription may be written for the listed drugs eculizumab, lanreotide, octreotide, pegcetacoplan, ravulizumab, and vedolizumab under the Special Arrangement. These changes are summarised, by subject matter, in the Attachment.
Background for deletion of transitional arrangements for combination chemotherapy drugs
In March 2023, Opdualag was recommended by the PBAC to be listed on the EFC Program for the treatment of patients with unresectable Stage III or Stage IV malignant melanoma, and in November 2023, Vyxeos was recommended by the PBAC to be listed on the EFC Program for the treatment of patients with therapy-related acute myeloid leukaemia (t-AML) or acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC). These medicines are referred to as ‘combination items’ which the Act defines as ‘a pharmaceutical item that has a drug that contains at least 2 other drugs or medicinal preparations, at least one of which is a listed drug’.
Opdualag and Vyxeos were the first two ‘combination items’ to have been recommended by the PBAC for listing on the EFC Program and could not immediately be listed on the EFC Program due to extensive system and administrative limitations for both the Department of Health, Disability an Ageing (department) and Services Australia. As an interim measure, Opdualag and Vyxeos were temporarily listed on the Highly Specialised Drugs (HSD) Program to facilitate subsidised patient access while the department sought to support the listing of combination items on the EFC Program.
The department reached a solution with the software system and was able to transition these medicines to the EFC Program on 1 December 2024. At that time, transitional arrangements were also enacted to allow Opdualag and Vyxeos to remain listed on the HSD Program for a period of 12 months under Supply Only arrangements to allow patients who had a PBS prescription written for either Opdualag or Vyxeos under the HSD Program to continue to have unfilled prescriptions supplied under the previous arrangements. That 12 months period has now been completed and the transitional arrangements are being removed from the Special Arrangement.
Authority
Subsection 100(1) of the Act enables the Minister, by legislative instrument, to make special arrangements for the supply of pharmaceutical benefits.
Subsection 100(2) of the Act provides that the Minister may, by legislative instrument, 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 has already taken place in the decision to list the medications outlined under ‘Purpose’.
Details of this Instrument are set out in the Attachment.
This Instrument commences on 1 December 2025.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
DETAILS OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT (DECEMBER UPDATE) INSTRUMENT 2025
Section 1 Name of Instrument
This section provides that the name of the Instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (December Update) Instrument 2025 and may also be cited as PB 138 of 2025.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2025.
Section 3 Authority
This section states that this Instrument is made under subsection 100(2) of the National Health Act 1953.
Section 4 Schedules
This section 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 transitional arrangements relating to the transfer of two combination chemotherapy drugs from the HSD Program to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (EFC Program), following completion of the 12 months transitional period.
The amendments also involve the addition of a form of a listed drug, the addition and deletion of brands of existing pharmaceutical benefits, and the alteration of circumstances in which a prescription may be written for various listed drugs available under the Special Arrangement. These changes are summarised below.
SUMMARY OF CHANGES TO THE HIGHLY SPECIALISEDDRUGS PROGRAM MADE BY THIS INSTRUMENT
Form Addition
Listed Drug | Form |
Ocrelizumab | Solution for subcutaneous injection 920 mg in 23 mL |
Brand Addition
Listed Drug | Form and Brand |
Apomorphine | Injection containing apomorphine hydrochloride hemihydrate 100 mg in 20 mL |
Brand Deletion
Listed Drug | Form and Brand |
Adalimumab | Injection 20 mg in 0.4 mL pre-filled syringe (Abrilada) |
| Injection 40 mg in 0.8 mL pre-filled syringe (Abrilada) |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug | Listed Drug |
Eculizumab | Pegcetacoplan |
Lanreotide | Ravulizumab |
Octreotide | Vedolizumab |
Documents Incorporated by Reference
Listed Drug | Document Incorporated | Document access |
Eculizumab Pegcetacoplan Ravulizumab | Approved Product Information/Australian Product Information/TGA-approved Product Information. 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 |
Eculizumab Pegcetacoplan Ravulizumab | New York Heart Association (NYHA) classification. The NYHA classification system is used to define the degree of heart failure. The different classes in the NYHA Functional Classification for heart failure are described below: Class/Patient Symptoms Class I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. Class II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. Class III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. Class IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort. | The NYHA classification system is available for download for free from the Heart Foundation website (contained within the heart failure clinical guidelines): https://www.heartfoundation.org.au/Conditions/Heart-failure-clinical-guidelines |
Lanreotide Octreotide | World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status/Performance Status Score. The WHO/ECOG 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 WHO/ECOG Performance Status is available for download for free from the ECOG-ACRIN Cancer Research Group 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 (Highly Specialised Drugs Program) Special Arrangement
Amendment (December Update) Instrument 2025
(PB 138 of 2025)
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.
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 UN Committee on Economic, Social and Cultural Rights (the Committee) reports that there is a strong presumption that retrogressive measures taken in relation to the right to social security are prohibited under ICESCR. In this context, a retrogressive measure would be one taken without adequate justification that had the effect of reducing existing levels of social security benefits, or of denying benefits to persons or groups previously entitled to them. However, it is legitimate for a government to re-direct its limited resources in ways that it considers to be more effective at meeting the general health needs of all society, particularly the needs of the more disadvantaged members of society.
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 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 National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (the Listing Instrument), that affect the pharmaceutical benefits that may be supplied under the Special Arrangement, are made concurrently.
This instrument provides for the deletion of transitional arrangements relating to the transfer of two combination chemotherapy drugs, daunorubicin with cytarabine (Opdualag) and nivolumab with relatlimab (Vyxeos), from the HSD Program to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (EFC Program), following completion of the 12 months transitional period. Access to these medicines remains unchanged as they are still available through the EFC Program.
This Instrument also provides for the addition of a form of the listed drug ocrelizumab, the addition of a brand of the listed drug apomorphine, and the deletion of a brand of the listed drug adalimumab.
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.
Where there are many brands of a listed drug and form, then the delisting of one brand will not adversely affect members of the public as they will be able to obtain any of the other equivalent brands. The delisting of brands in this Instrument will not affect access to the drugs, as affected patients will be able to access equivalent brands, at the same cost. Consequently, the brand delistings in this instrument do not result in an unmet clinical need. Note that delisting of maximum quantities, number of repeats, and pack sizes are equivalent to brand delistings.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Rebecca Richardson
Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Department of Health, Disability and Ageing