EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Pharmacogenetic Testing – Kirsten ras (KRAS)) Determination 2014
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 (Pharmacogenetic Testing – Kirsten ras (KRAS)) Determination 2014 (the Determination) is to create a new Medicare pathology service, item 73338. This item allows for the testing of tumour tissue from a patient with metastatic colorectal cancer to determine if the patient meets the requirements relating to Kirsten ras (KRAS) gene mutation status for access to either cetuximab or panitumumab under the Pharmaceutical Benefits Scheme (PBS).
Research indicates that cetuximab and panitumumab have reduced effectiveness in tumours with a KRAS mutation. Testing tumours in patients for KRAS mutation will assist in identifying a population for whom treatment with PBS-subsidised cetuximab or panitumumab is appropriate.
The item descriptor for item 73338 provides it must be requested by a specialist or consultant physician.
Consultation
Testing of tumours for KRAS gene mutation status to determine access to cetuximab under the PBS has been provided for under Medicare since 2012. A fit-for-purpose minor submission was considered by the Medical Services Advisory Committee (MSAC) in April 2013 to expand Medicare access service to include pathology testing to determine PBS access to a new drug, panitumumab, following approval to list the drug under the PBS. MSAC provides advice to the Australian Government on evidence relating to the safety, effectiveness and cost-effectiveness of new medical technology and procedures. MSAC recommended that public funding be supported for this service.
The Determination commences on 1 April 2014.
This 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 (Pharmacogenetic Testing – Kirsten ras (KRAS)) Determination 2014
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 (Pharmacogenetic Testing – Kirsten ras (KRAS)) Determination 2014 (the Determination) creates a new Medicare pathology service (item 73338) for the testing of tumour tissue from a patient with metastatic colorectal cancer to determine if the patient meets the requirements relating to Kirsten ras (KRAS) gene mutation status for access to cetuximab or panitumumab under the Pharmaceutical Benefits Scheme (PBS).
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 this clinically relevant medical service. There are no limitations on access to new item 73338 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.
Richard Bartlett
First Assistant Secretary
Medical Benefits Division
Department of Health