EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT (DECEMBER UPDATE) INSTRUMENT 2024
PB 127 of 2024
Purpose
This is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (December Update) Instrument 2024 (PB 127 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 (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, including changes relating to the transition of Opdualag® (nivolumab with relatlimab) and Vyxeos® (daunorubicin with cytarabine) to the Special Arrangement relating to the Efficient Funding of Chemotherapy (EFC) Program, consistent with the Pharmaceutical Benefits Advisory Committee (PBAC) recommendations.
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) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
Schedule 1 to this Instrument provides for the deletion of the listed drugs daunorubicin with cytarabine and nivolumab with relatlimab, which are both transitioning to the Special Arrangement for the EFC Program as detailed below under “background for combination chemotherapy listings”. It also provides for the deletion of forms of the listed drug epoprostenol, the deletion of brands of the listed drugs lenalidomide and nevirapine, the addition of a maximum quantity and number of repeats for a brand of the listed drug zoledronic acid, and the alteration of circumstances in which a prescription may be written for the listed drug vedolizumab 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).
Background for combination chemotherapy listings
Two medicines, Opdualag (nivolumab with relatlimab) and Vyxeos (daunorubicin with cytarabine), were initially recommended by the PBAC for listing on the EFC Program. These medicines are referred to as ‘combination items’ which the National Health Act 1953 (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’.
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. In November 2023, Vyxeos was recommended by the PBAC for the treatment of patients with therapy-related acute myeloid leukaemia (t-AML) or acute myeloid leukaemia with myelodysplasia-related changes (AML-MRC).
Opdualag and Vyxeos were the first two ‘combination items’ that have been recommended by the PBAC for listing on the EFC Program. However, these medicines could not be listed on the EFC Program due to extensive system and administrative limitations for both the Department of Health and Aged Care (department) and Services Australia. 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. On 1 February 2024, Opdualag was listed on the HSD Program and on 1 July 2024, Vyxeos was listed on the HSD Program.
The department has reached a solution with the software system and is now able to transition these medicines to the EFC Program. The current system will list these medicines in the EFC Program by using the maximum amount for one ingredient against Pharmaceutical Benefits Scheme (PBS) claiming, with the full combination medicine description in the administrative notes.
Opdualag and Vyxeos will remain listed on the HSD Program for a period of 12 months under the special supply arrangements. This means that patients who had a PBS prescription written for either Opdualag or Vyxeos under the HSD Program, may continue to have unfilled prescriptions supplied under the previous arrangements.
Amendments are also being made to the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (PB 31 of 2024) (via the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (December Update) Instrument 2024 (PB 128 of 2024)) to reflect the transitioning of these two chemotherapy medicines from the HSD Program to the EFC Program. The National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (December Update) Instrument 2024 (PB 128 of 2024) commences on the same day as this Instrument.
Consultation
The amendments made by this Instrument, including those amendments which relate to the transition of Opdualag and Vyxeos to the EFC Program, accord with recommendations made by the 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.
The department consulted with the sponsors of both Opdualag and Vyxeos regarding the challenges posed with listing combination medicines on the EFC Program. The sponsors were made aware that the required system and administrative changes would delay the listing of Opdualag and Vyxeos on the EFC Program. The sponsors were supportive of having Opdualag and Vyxeos listed on the HSD Program until the EFC Program could accommodate the listing.
Services Australia was also consulted throughout this process to ensure that IT systems would be able to accommodate the listings of Opdualag and Vyxeos on the EFC Program.
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 2024.
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 2024
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 2024 and may also be cited as PB 127 of 2024.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 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
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
Item 1 Definition of CAR drug
This item amends the definition of CAR drug in section 6 of the Special Arrangement to remove the drug daunorubicin with cytarabine from the definition, consequential to the transition of this drug from the HSD Program to the EFC Program.
Item 2 At the end of Part 6
Item 2 adds a new Division 3 at the end of Part 6 which sets out provisions relating to the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (December Update) Instrument 2024 (the Instrument). This includes the addition of a new definition provision, being section 51, which defines “amending instrument” and “EFC transition drug”. These definitions assist in interpreting the newly added section 52.
This item deals with the validity of Pharmaceutical Benefits Scheme (PBS) prescriptions which were written under the Highly Specialised Drugs (HSD) Program prior to 1 December 2024 and prior to them transitioning to the Efficient Funding of Chemotherapy (EFC) Program. It will allow patients who have unfilled PBS prescriptions to still have them ‘supplied’ under the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (Special Arrangement). As such, despite Opdualag® (nivolumab with relatlimab) and Vyxeos® (daunorubicin with cytarabine) transitioning to the EFC Program, these two medicines can still be supplied under the HSD Program. However, prescribers will no longer be able to write new PBS prescriptions for these two medicines once this Instrument commences.
Further, item 1 ensures that on and after 1 December 2024, the supply of Opdualag and Vyxeos will still be a pharmaceutical benefit under the HSD Program and remain as Complex Authority Required (CAR) drugs, as defined in the Special Arrangement.
Items 3 to 17 involve the deletion of listed drugs, the deletion of forms of a listed drug, the deletion of brands of listed drugs, the addition of a maximum quantity and number of repeats for a brand of pharmaceutical item, and the alteration of circumstances in which a prescription may be written for a listed drug available under the Special Arrangement. These changes are summarised below.
SUMMARY OF CHANGES TO THE HIGHLY SPECIALISED DRUGS PROGRAM MADE BY THIS INSTRUMENT
Drugs Deleted - Transitioned to EFC Program
Listed Drug |
Daunorubicin with cytarabine |
Nivolumab with relatlimab |
Forms Deleted
Listed Drug | Form |
Epoprostenol | Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL |
Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL |
Brands Deleted
Listed Drug | Form and Brand |
Lenalidomide | Capsule 5 mg (Cipla Lenalidomide) |
Capsule 10 mg (Cipla Lenalidomide) | |
Capsule 15 mg (Cipla Lenalidomide) | |
Capsule 25 mg (Cipla Lenalidomide) | |
Nevirapine | Tablet 200 mg (Nevirapine Alphapharm) |
Addition of Maximum Quantity and Number of Repeats
Listed Drug | Form | Brand Name | Maximum Quantity | Number of Repeats |
Zoledronic acid | Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL | (Zoledronate‑DRLA 4) | 1 | 0 |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Vedolizumab |
Documents Incorporated by Reference
Listed Drug | Document incorporated | Document access |
Vedolizumab | Modified Pouchitis Disease Activity Index (mPDAI) & minimum endoscopic mPDAI sub‑score. | The mPDAI is available for download for free from: www.yumpu.com/en/document/read/4702016/modified-pouchitis-disease-activity-index-a-cleveland-clinic |
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 2024
(PB 127 of 2024)
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, including changes relating to the transition of two chemotherapy medicines to the Special Arrangement relating to the Efficient Funding of Chemotherapy (EFC) Program consistent with the recommendation of the Pharmaceutical Benefits Advisory Committee (PBAC).
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 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 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 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 transitioning of two chemotherapy combination medicines, Opdualag and Vyxeos, for the Special Arrangement. The transition provisions within this Instrument and the inclusion of the combination items Opdualag and Vyxeos on the EFC Program from 1 December 2024 are compatible with and advance the right to health by ensuring that eligible patients will continue to be able to obtain PBS subsidised access to these drugs, without which they would only be available through private funding at a significantly greater cost to patients.
This Instrument also provides for the deletion of forms of the listed drug epoprostenol and the deletion of brands of the listed drugs lenalidomide and nevirapine from 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.
If 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 deletion 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.
The drug epoprostenol in the forms powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL (Folan) and powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL (Folan) were requested to be delisted from the PBS Schedule by the sponsor. There are other substitutable forms of epoprostenol available on the PBS and the delisting of these products will not result in an unmet clinical need.
Conclusion
This Instrument is compatible with human rights because it advances the protection of human rights.
Eden Simon
Assistant Secretary (Acting)
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health and Aged Care