EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Pharmacogenetic Testing – RAS (KRAS and NRAS)) 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 – RAS (KRAS and NRAS)) Determination 2014 (the Determination) is to update the Medicare pathology service item 73338. The Determination revokes and replaces the Health Insurance (Pharmacogenetic Testing Kirsten ras (KRAS)) Determination 2014.
Item 73338 previously enabled the payment of Medicare benefit for the testing of tumour tissue from a patient with metastatic colorectal cancer to determine if the patient met the requirements relating to Kirsten ras (KRAS) gene mutation status for access to either cetuximab or panitumumab under the Pharmaceutical Benefits Scheme (PBS). Cetuximab and panitumumab are epidermal growth factor receptor (EGFR) inhibitors and are used in the treatment of certain cancers.
Recent clinical evidence indicates the current restrictions on the use of anti-EGFR antibodies based on only identifying whether the patient is a KRAS wild-type patient (i.e. does not have a KRAS gene mutation) are too limited. Expanding genetic testing to include testing for RAS mutations and limiting PBS subsidy of cetuximab and panitumumab to those patients demonstrated to have no RAS mutations, rather than just no KRAS mutations, supports improved health outcomes.
The updated item descriptor for item 73338 now provides for the payment of Medicare benefit for testing a patient’s RAS gene mutation status, and therefore whether they will be eligible for cetuximab and panitumumab under the PBS, if:
(a) the test is conducted for all clinically relevant mutations on KRAS exons 2, 3 and 4 and NRAS exons 2, 3 and 4; or
(b) a RAS mutation is found.
Enabling the requirements of the item descriptor to be met once any RAS mutation is found means that once the test indicates that the patient is not RAS wild-type and therefore not suitable for access to cetuximab and panitumumab under the PBS, the pathologist is not required to continue testing for other clinically relevant mutations.
The schedule fee has been increased to $362.59 in recognition of the increased costs involved in testing for additional mutations.
Item 73338 must still be requested by a specialist or consultant physician.
Consultation
Testing of tumours for KRAS gene mutation status to determine access to cetuximab and panitumumab under the PBS has been provided for under Medicare since April 2014. A fit-for-purpose submission was considered by the Medical Services Advisory Committee (MSAC) on 3 October 2014 to expand Medicare access service to accommodate expanded RAS mutation testing. MSAC recommended that public funding be supported for this service.
MSAC provides advice to the Australian Government on evidence relating to the safety, effectiveness and cost-effectiveness of new medical technology and procedures.
The Determination commences on 1 January 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 (Pharmacogenetic Testing – RAS (KRAS and NRAS)) 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 – RAS (KRAS and NRAS)) Determination 2014 (the Determination) revokes and replaces Health Insurance (Pharmacogenetic Testing Kirsten ras (KRAS)) Determination 2014 to update a Medicare pathology service (item 73338).
Item 73338 previously enabled the payment of Medicare benefit for the testing of tumour tissue from a patient with metastatic colorectal cancer to determine if the patient met the requirements relating to Kirsten ras (KRAS) gene mutation status for access to either cetuximab or panitumumab under the Pharmaceutical Benefits Scheme (PBS). A KRAS gene mutation is a contraindication for the use of cetuximab or panitumumab, both of which are antibodies that act as epidermal growth factor receptor (EGFR) inhibitors and are used in the treatment of certain cancers.
Recent clinical evidence indicates the current restrictions on the use of anti-EGFR antibodies based only on identifying whether the patient has a KRAS gene mutation are too limited. Expanding genetic testing to include testing for all RAS mutations and limiting PBS subsidy to those patients demonstrated to have no RAS mutations, rather than just no KRAS mutations, supports improved health outcomes.
The updated item descriptor for item 73338 now provides for the payment of Medicare benefit for testing of a patient’s RAS gene mutation status, and therefore whether they will be eligible for cetuximab and panitumumab under the PBS, if:
(a) the test is conducted for all clinically relevant mutations on KRAS exons 2, 3 and 4 and NRAS exons 2, 3 and 4; or
(b) a RAS mutation is found.
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 for all RAS mutations, not just KRAS mutations. This supports better health outcomes for patients. The Schedule Fee for item 73338 has been increased to $362.59 in recognition of the increased costs involved in testing for additional mutations.
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.
Kirsty Faichney
Acting First Assistant Secretary
Medical Benefits Division
Department of Health