EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 6) 2022
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may, by legislative instrument, determine that a health service not specified in an item in the pathology services table (the Table) shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the Table.
The Table is set out in the regulations made under section 4A of the Act. The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulations 2020.
This instrument relies on subsection 33(3) of the Acts Interpretation Act 1901 (AIA). Subsection 33(3) of the AIA provides that where an Act confers a power to make, grant or issue any instrument of a legislative or administrative character (including rules, regulations or by-laws), the power shall be construed as including a power exercisable in the like manner and subject to the like conditions (if any) to repeal, rescind, revoke, amend, or vary any such instrument.
Purpose
The purpose of the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 6) 2022 (the Amendment Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 (Co-Dependent Pathology Services Determination). Under this Amendment Determination, three existing items (73337, 73341 and 73344) will be amended and one new item (73436) will be created.
From 1 November 2022, the Amendment Determination will amend existing items 73337, 73341 and 73344 to replace the reference to the specific drug ‘pembrolizumab’ with a more general reference to ‘an immunotherapy’ which will cover pembrolizumab, cemiplimab, other Pharmaceutical Benefits Scheme (PBS) listed immunotherapies and future listed drugs. This enables Medicare benefits to be payable for biomarker testing for the evaluation of the absence of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS proto-oncogene (ROS1) to determine patient eligibility for treatment with a PBS listed immunotherapy drug, such as cemiplimab or pembrolizumab. Cemiplimab and pembrolizumab, are immunotherapy drugs that are used to treat a number of cancers.
In November 2021, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of cemiplimab for the treatment of patients with previously untreated metastatic non‑small cell lung cancer (NSCLC) with a Programmed Death-Ligand 1 (PD-L1) tumour proportion score greater than or equal to 50 per cent with no evidence of an EGFR gene, an ALK gene rearrangement or a ROS1 gene arrangement in tumour materials. At its November 2021 meeting, the Medical Services Advisory Committee (MSAC) supported amendments to Medicare Benefits Schedule (MBS) items 73337, 73341 and 73344 to enable Medicare benefits to be payable for biomarker testing to determine if the PBS requirements for cemiplimab relating to EGFR, ALK or ROS1 gene status are met.
The Amendment Determination will insert new item 73436 from 1 November 2022. The new item will provide Medicare funding for MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 skipping alterations (METex14sk) testing in patients with locally advanced or metastatic NSCLC to determine eligibility for treatment with tepotinib under the PBS. METex14sk are a specific type of genetic variation that can result in faster tumour growth and patients with METex14sk commonly have a worse prognosis than those without these alterations. Tepotinib is a targeted drug that can improve health outcomes in patients who have METex14sk.
At its March 2022 meeting, the PBAC recommended the PBS listing of tepotinib for the treatment of patients with local advanced or metastatic MET exon 14 skipping alterations-positive NSCLC. MSAC had previously supported the creation of a new MBS item for METex14sk testing in patients with locally advanced or metastatic NSCLC to determine eligibility for tepotinib under the PBS at its November 2021 meeting.
Consultation
MSAC reviews new or existing medical services or technology, and the circumstances under which public funding should be supported through listing on the Medicare Benefits Schedule (MBS). This includes the listing of new items, or amendments to existing items on the MBS.
During the MSAC process, letters of support for the listing of a new item for METex14sk testing in patients with NSCLC were received from Rare Cancers Australia and Genomics for Life.
The Department did not consult on the changes to items 73337, 73341 and 73344 as this is a minor change to replace a specific PBS listed drug name with a generic term for the class of PBS listed drug and considered to be minor in nature.
Details of the Amendment Determination are set out in the Attachment.
The Amendment Determination commences on 1 November 2022.
The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.
Authority: Subsection 3C(1) of the
Health Insurance Act 1973
ATTACHMENT
Details of the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 6) 2022
Section 1 – Name
Section 1 provides for the Amendment Determination to be referred to as the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 6) 2022.
Section 2 – Commencement
Section 2 provides that the Amendment Determination commences on 1 November 2022.
Section 3 – Authority
Section 3 provides that the Amendment Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
Section 4 – Schedules
Section 4 provides that each instrument that is specified in a Schedule to this Amendment Determination is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Amendment Determination has effect according to its terms.
Schedule 1 – Amendments
Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018
Amendment item 1 amends items 73337, 73341 and 73344 to replace the reference to the specific drug ‘pembrolizumab’ with a general reference to ‘immunotherapy’. This change will enable Medicare benefits to be payable for biomarker testing for the evaluation of the absence of EGFR, ALK or ROS1 to determine patient eligibility for treatment with a PBS listed immunotherapy drug, such as cemiplimab or pembrolizumab.
Amendment item 2 inserts item 73436, which is for METex14sk testing in patients with locally advanced or metastatic NSCLC to determine eligibility for treatment with tepotinib under the PBS. This new item will allow Medicare benefits to be payable for METex14sk testing in patients with locally advanced or metastatic NSCLC to determine eligibility for treatment with tepotinib under the PBS.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 6) 2022
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 Determination
The purpose of the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 6) 2022 (the Amendment Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 (Co-Dependent Pathology Services Determination). Under this Amendment Determination, three existing items (73337, 73341 and 73344) will be amended and one new item (73436) will be inserted.
From 1 November 2022, the Amendment Determination will amend existing items 73337, 73341 and 73344 to replace the reference to the specific drug ‘pembrolizumab’ with a more general reference to ‘an immunotherapy’ which will cover pembrolizumab, other Pharmaceutical Benefits Scheme (PBS) listed immunotherapies and future listed drugs. This enables Medicare benefits to be payable for biomarker testing for the evaluation of the absence of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS proto-oncogene (ROS1) to determine patient eligibility for treatment with a PBS listed immunotherapy drug, such as cemiplimab or pembrolizumab. Cemiplimab and pembrolizumab, are immunotherapy drugs that are used to treat a number of cancers.
In November 2021, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of cemiplimab for the treatment of patients with previously untreated metastatic non‑small cell lung cancer (NSCLC) with a Programmed Death-Ligand 1 (PD-L1) tumour proportion score greater than or equal to 50 per cent. At its November 2021 meeting, the Medical Services Advisory Committee (MSAC) supported public funding for PD-L1 testing in patients diagnosed with NSCLC in alignment with PBAC’s decision to list cemiplimab on the PBS.
The Amendment Determination will insert new item 73436 from 1 November 2022. The new item will be listed for METex14sk testing in patients with locally advanced or metastatic NSCLC to determine eligibility for treatment with tepotinib under the PBS. METex14sk are a specific type of genetic variation that can result in cancer growth. Patients with METex14sk commonly have a worse prognosis than those without these alterations. tepotinib is a targeted drug that can improve health outcomes in patients who have METex14sk.
At its March 2022 meeting, the PBAC recommended the listing of tepotinib for the treatment of patients with local advanced or metastatic MET exon 14 skipping alterations-positive NSCLC. MSAC had previously supported the creation of a new Medicare Benefits Schedule (MBS) item for METex14sk testing in patients with locally advanced or metastatic NSCLC to determine eligibility for tepotinib under the PBS at its November 2021 meeting.
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 health and social security.
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.
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 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 of equality and non-discrimination
The rights of equality and non-discrimination are contained in articles 2, 16 and 26 of the International Covenant on Civil and Political Rights (ICCPR). Article 26 of the ICCPR requires that all persons are equal before the law, are entitled without any discrimination to the equal protection of the law and in this respect, the law shall prohibit any discrimination and guarantee to all persons equal and effective protection against discrimination on any ground such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status.
Analysis
This instrument advances the existing rights to health, the right to social security and the right of equality and non-discrimination by providing patients diagnosed with locally advanced or metastatic NSCLC access to Medicare benefits for METex14sk testing to gain access to tepotinib, which is a targeted drug that can improve health outcomes in patients who have METex14sk alterations, under the PBS.
This instrument also amends three items to replace the reference to a specific PBS immunotherapy drug, pembrolizumab, with a general reference to ‘an immunotherapy’. This change will enable Medicare benefits to be payable for biomarker testing for the evaluation of the absence of EGFR, ALK or ROS1 to determine patient eligibility for treatment with a PBS listed immunotherapy drug, such as cemiplimab or pembrolizumab. Cemiplimab and pembrolizumab, are immunotherapy drugs that are used to treat a number of cancers.
Conclusion
This instrument is compatible with human rights as it advances the right to health, the right to social security and the right of equality and non-discrimination.
Nigel Murray
Assistant Secretary
MBS Policy and Specialist Services
Medical Benefits Division
Department of Health and Aged Care