National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (February Update) Instrument 2024

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM)
SPECIAL ARRANGEMENT AMENDMENT (FEBRUARY UPDATE) INSTRUMENT 2024

PB 5 of 2024

Purpose

This is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (February Update) Instrument 2024 (PB 5 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.

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 interim addition of the listed drug nivolumab with relatlimab to the HSD Program. Nivolumab with relatlimab is the first combination medicine (as it contains more than one active ingredient in a single pre-mixed vial) to be listed on the Special Arrangement.

Schedule 1 also includes the addition of a form of the listed drug natalizumab, and the addition of brands of the listed drugs mycophenolic acid and tenofovir. Additionally, it provides for the deletion of the listed drug efavirenz, and the deletion of brands of the listed drugs ambrisentan, bosentan, cinacalcet, deferasirox, octreotide, pegfilgrastim, sildenafil, and tenofovir with emtricitabine and efavirenz 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 nivolumab with relatlimab listing

Nivolumab with relatlimab received a positive recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2023 for the treatment of patients with unresectable Stage III or Stage IV malignant melanoma, on the basis that it should be available under the Section 100 Efficient Funding of Chemotherapy (EFC) Program.

The Department of Health and Aged Care in consultation with Services Australia determined that extensive system and administrative changes would be required for both the Department and Services Australia to facilitate the inclusion of a combination medicine on the EFC Program. Delaying this listing until current systems are able to recognise a combination medicine would, however, disadvantage patients seeking treatment with this medicine.

In July 2023, the PBAC made a recommendation to list nivolumab with relatlimab on the HSD Program as an interim listing. This would mitigate delays to patient access and allow system changes to be completed so that nivolumab with relatlimab can be transitioned to the EFC Program in due course.

While nivolumab with relatlimab is listed on the HSD Program, it is not possible for the system to administer a HSD Program medicine with the same program policy of an EFC Progam medicine. The HSD Program listing of nivolumab with relatlimab  will attract a patient co-payment for each repeat prescription, whereas under the EFC Program, patients do not pay for repeat supplies of the medicine. The Department understands the additional financial burden this may place on patients, however, the availability of nivolumab with relatlimab  on the Pharmaceutical Benefits Scheme (PBS) provides for subsidised access to the medicine that would not be available if a listing on the HSD Program was not considered.

Consultation

The amendments made by this Instrument in relation to the inclusion of nivolumab with relatlimab  on the Special Arrangement accords with recommendations made by the PBAC.

Consultation in relation to matters relevant to the Special Arrangement occurs through an ongoing and formal process with interested parties through membership with 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 sponsor of nivolumab with relatlimab  regarding the challenges posed with listing a combination medicine on the EFC Program. The sponsor was made aware that the required system and administrative changes would delay the listing of nivolumab with relatlimab  on the EFC Program.

The sponsor was supportive of having nivolumab with relatlimab  listed on the HSD Program until the EFC Program could be modified to enable the listing. Although patients will not be able to access this medicine under the same conditions as if it were listed on the EFC Program, listing the medicine on the HSD Program is a positive interim solution. This solution enables patients access to nivolumab with relatlimab  at a PBS subsidised price rather than delaying access and charging patients private fees for this medicine.

The Department is continuing to consult and work with Services Australia regarding system and administrative changes required to facilitate the future listing of nivolumab with relatlimab  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 February 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 (FEBRUARY UPDATE) INSTRUMENT 2024

Section 1 Name of Instrument

This section provides that the Instrument is the National Health (Highly Specialised Drugs Program) Special Arrangement Amendment (February Update) Instrument 2024 and may also be cited as PB 5 of 2024.

Section 2 Commencement

This section provides that this Instrument commences on 1 February 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

The amendments in Schedule 1 involve the addition and deletion of listed drugs, the addition of a form of a listed drug, and the addition and deletion of brands of listed drugs. These changes are summarised below.

SUMMARY OF CHANGES TO THE HIGHLY SPECIALISED
DRUGS PROGRAM MADE BY THIS INSTRUMENT

Drug Added

Drug Deleted

Form Added

Brands Added

Brands Deleted

Documents Incorporated by Reference

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 (February Update) Instrument 2024

(PB 5 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.

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 2012 (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 the listed drug nivolumab with relatlimab, the addition of a form of the listed drug natalizumab, and the addition of brands of the listed drugs mycophenolic acid and tenofovir. Additionally, it provides for the deletion of the listed drug efavirenz, and the deletion of brands of the listed drugs ambrisentan, bosentan, cinacalcet, deferasirox, octreotide, pegfilgrastim, sildenafil, and tenofovir with emtricitabine and efavirenz.

The interim inclusion of the combination medicine, nivolumab with relatlimab, on the HSD Program is compatible with and advances the right to health by ensuring that eligible patients will be in a position to obtain early PBS subsidised access to this drug, without which nivolumab with relatlimab would only be available through private funding at a significantly greater cost to patients.

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. PBAC also considers whether the delisting of a form of a drug will result in an unmet clinical need for patients.

Written advice from PBAC is tabled with the monthly amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). 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 the form of drugs in the abovementioned instruments, would not result in an unmet clinical need. The delisting of these items will not affect access to the drugs, 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 fees are up to $31.60 for general patients and up to $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 efavirenz, in the forms tablet 200 mg (Stocrin) and tablet 600 mg (Stocrin), 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 and that there are multiple alternatives available on the PBS. The PBAC noted the sponsor intends to discontinue supply of this product in Australia. The PBAC advised the delisting of this drug would not result in an unmet clinical need. These items were available on the Schedule under Supply Only arrangements for a period of 6 months, allowing patients with a pre‑existing valid prescription to access this item pending transition to an alternative treatment option.

Conclusion

This 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