EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Section 3C Pathology Services—ALK Gene Testing) Amendment Determination 2018
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 shall, in specified circumstances and for specified statutory provisions, be treated as if it were specified in the pathology services table.
The pathology services table is set out in the regulations made under subsection 4A(1) of the Act, which is re-made each year. The most recent version of the regulations is the Health Insurance (Pathology Services Table) Regulations 2017 which commenced on 17 June 2017.
Purpose
The purpose of the Health Insurance (Section 3C Pathology Services—ALK Gene Testing) Amendment Determination 2018 is to amend the Health Insurance (ALK Gene Testing) Determination 2017. The Determination will amend the descriptor of item 73341 to reflect the listing on the Pharmaceutical Benefits Scheme (PBS) of alectinib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC).
Item 73341 funds a fluorescence in situ hybridisation (FISH) test for patients with NSCLC. Specifically, the test is for the anaplastic lymphoma kinase (ALK) gene rearrangement, to determine eligibility for treatment with crizotinib or ceritinib on the PBS. The Determination will amend item 73341 to allow for ALK gene testing to determine eligibility for treatment with alectinib, in addition to crizotinib or ceritinib, on the PBS. This change was recommended by Pharmaceutical Benefits Advisory Committee (PBAC) at its meeting in July 2017, and endorsed by the Medical Services Advisory Committee (MSAC).
Consultation
Consultation was previously undertaken for the original listing of item 73341 in the Health Insurance (ALK Gene Testing) Determination 2015. The creation of the new item was considered and agreed to by MSAC and informed by clinical experts from the Pathology Clinical Committee. There is no change to the pathology service which is listed in the 2015 Determination.
MSAC reviews new or existing medical services or technology, and the circumstances under which public funding should be supported through listing on the MBS. This includes the listing of new items, or amendments to existing items on the MBS.
The listing of alectinib was recommended by PBAC, and endorsed by MSAC.
Details of the Determination are set out in the Attachment.
The Determination commences the day after registration.
The 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 Pathology Services—ALK Gene Testing) Amendment Determination 2018
Section 1 – Name of Determination
Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Pathology Services—ALK Gene Testing) Amendment Determination 2018.
Section 2 – Commencement
Section 2 provides that the Determination commences on the day after registration.
Section 3 – Authority
Section 3 provides that the Determination is made under subsection 3C(1) of the Health Insurance Act 1973.
Section 4 – Amendment of the Health Insurance (ALK Gene Testing) Determination 2017
This section provides that Schedule 1 amends the Health Insurance (ALK Gene Testing) Determination 2017.
Schedule 1 – Amendments
Schedule 1 amends the descriptor of item 73341 to omit “crizotinib or ceritinib” and substitute with “crizotinib, ceritinib or alectinib”.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (Section 3C Pathology Services—ALK Gene Testing) Amendment Determination 2018
This Determination 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 Disallowable Legislative Instrument
The Health Insurance (Section 3C Pathology Services—ALK Gene Testing) Amendment Determination 2018 (the Determination) amends the Health Insurance (ALK Gene Testing) Determination 2017 to allow ALK gene testing item 73341 to determine eligibility for treatment with alectinib on the Pharmaceutical Benefits Scheme.
Human rights implications
The Determination 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.
Analysis
This Determination will maintain rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective and cost-effective.
Conclusion
This Disallowable Legislative Instrument is compatible with human rights as it has a positive effect on human rights issues.
Celia Street
Assistant Secretary
Diagnostic Imaging and Pathology Branch
Medical Benefits Division
Department of Health