EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (ALK Gene Testing) Determination 2015
Subsection 3C(1) of the Health Insurance Act 1973 (the Act) provides that the Minister may determine in writing 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 so specified. The Table is set out in the Health Insurance (Pathology Services Table) Regulation (the Regulation), which is re-made each year.
The purpose of the Health Insurance (ALK Gene Testing) Determination 2015 (the Determination) is to create a new Medicare pathology service, item 73341. Item 73341 is for fluorescence in situ hybridisation (FISH) testing in patients with non-small cell lung cancer (NSCLC) for identification of anaplastic lymphoma kinase (ALK) gene rearrangement to determine eligibility for treatment under the Pharmaceuticals Benefits Scheme (PBS) with crizotinib. Crizotinib is expected to become available on the PBS from 1 July 2015.
FISH testing for ALK gene rearrangement will assist in guiding the appropriate choice of chemotherapy for patients with NSCLC. Approximately 3% of patients with advanced or metastatic NSCLC which is of non-squamous histology or histology not otherwise specified and with an absence of activating mutations on the epidermal growth factor receptor gene will have an ALK gene rearrangement. While there are multiple treatments for locally advanced or metastatic NSCLC, some of which will be effective in patients with ALK gene rearrangements, crizotinib is the only treatment that specifically targets ALK tyrosine kinase activity.
Item 73341 must be requested by a specialist or consultant physician.
Consultation
A co-dependent application was resubmitted by Abbott Molecular and Pfizer Australia to the Medical Services Advisory Committee (MSAC) in March 2014 requesting reconsideration of Medicare Benefits Schedule (MBS) listing of FISH testing in patients with advanced or metastatic NSCLC for identification of ALK gene rearrangement to determine eligibility for crizotinib under the Pharmaceutical Benefits Scheme.
The application was considered by MSAC in October and November 2014. After considering the strength of the available evidence in relation to the safety, clinical effectiveness and cost-effectiveness of the test, MSAC advised that it supported public funding for this service through the creation of a new MBS item.
The Determination commences on 1 July 2015.
The Determination is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Health Insurance (ALK Gene Testing) Determination 2015
This Legislative 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 Legislative Instrument
The Health Insurance (ALK Gene Testing) Determination 2015 (the Determination) creates a new Medicare pathology service (item 73341) for fluorescence in situ hybridisation (FISH) testing in patients with non-small cell lung cancer for identification of anaplastic lymphoma kinase (ALK) gene rearrangement to determine eligibility for treatment under the Pharmaceutical Benefits Scheme (PBS) with crizotinib.
ALK gene rearrangement testing will assist in guiding the appropriate choice of chemotherapy and determine eligibility for PBS subsidised crizotinib, which is the only treatment that specifically targets ALK tyrosine kinase activity. Approximately 3% of patients with advanced or metastatic non-small cell lung cancer which is of non-squamous histology or histology not otherwise specified and with an absence of activating mutations on the epidermal growth factor receptor gene will have an ALK gene rearrangement.
Human rights implications
This Determination engages Articles 2, 9 and 12 and 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 has also stated that the ‘highest attainable standard of health’ takes into account the country’s available resources. The 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 realization of the highest attainable standard of health.
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.
Analysis
The Determination will advance the human rights to health and social security by enabling the payment of Commonwealth Medicare benefit to assist private patients with financial costs associated with receiving testing to identify ALK gene rearrangement for the purpose of access to crizotinib under the PBS. While there are a number of treatments for locally advanced or metastatic non-small cell lung cancer, crizotinib is the only treatment that specifically targets ALK tyrosine kinase activity. This supports better health outcomes for patients.
There are no limitations on access to new item 73341 based on grounds such as the sex, age or race of the patient.
Conclusion
This Determination is compatible with the human rights recognised in the Human Rights (Parliamentary Scrutiny) Act 2011.
Catherine Rule
First Assistant Secretary
Medical Benefits Division
Department of Health