EXPLANATORY STATEMENT
Health Insurance Act 1973
Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination
(No. 5) 2020
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The Table is set out in the regulations made under subsection 4A(1) of the Act, which is repealed and remade each year. 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. 5) 2020 (the Determination) is to amend the Health Insurance (Section 3C
Co-Dependent Pathology Services) Determination 2018. This amendment will enable the addition of entrectinib to Medicare Benefits Scheme (MBS) item 73344, and to amend item 73295 and list two new items 73301 and 73302 to expand testing for access to olaparib to patients who have BRCA variants detected, regardless of whether the BRCA variants are the result of germline variant/s or not.
Addition of entrectinib to item 73344
Item 73344 commenced on 1 January 2019 for fluorescent in situ hybridisation (FISH) testing for ROS proto-oncogene 1 (ROS1) rearrangements in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), to determine access to crizotinib under the Pharmaceutical Benefits Scheme (PBS).
The addition of entrectinib to item 73344 will facilitate access to an additional PBS listed treatment for eligible patients with ROS1-positive NSCLC. The Determination will amend item 73344 to enable testing for the ROS1 gene rearrangement by FISH to determine eligibility for newly PBS-subsidised entrectinib, in addition to crizotinib.
The proposal to amend item 73344 to include entrectinib was supported by the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2020 and the Medical Services Advisory Committee (MSAC) in April 2020.
Amendment to item 73295 and introduction of new items 73301 and 73302
Item 73295 commenced on 1 February 2017 for the detection of germline BRCA1 and BRCA2 mutation in selected patients with relapsed ovarian fallopian tube or primary peritoneal cancer with continued sensitivity to platinum-based chemotherapy, to inform eligibility for olaparib under the PBS.
Item 73295 is currently available to patients with ovarian, fallopian tube or primary peritoneal cancer whose cancer has come back (relapsed) after initial response to treatment. Subsequent treatment after the first treatment that either was not effective or is no longer effective is called second-line treatment. Patients with ovarian fallopian tube or primary peritoneal cancer can be tested to see if they have a germline BRCA gene mutation, and if they do they can get olaparib as second-line treatment. However, a service under 73295 cannot be provided for testing of BRCA genes for mutations in a sample from the tumour.
Genetic testing is the only way to confirm if someone has a gene mutation. Genetic testing can be done on a blood sample to determine if the mutation is inheritable (germline testing). It can also be done on a sample from the tumour, which can be taken during surgery, to determine what mutations are present in the tumour (somatic testing).
From 1 August 2020, patients with epithelial ovarian, fallopian tube or primary peritoneal cancer will be able to access the MBS to detect both somatic and germline BRCA1 or BRCA2 variants, to determine eligibility to access olaparib. This will enable the testing for BRCA mutations in tumour samples from patients with these cancers, enabling access to olaparib as a second-line treatment. Access to olaparib may assist patients with ovarian fallopian tube or primary peritoneal cancer and a BRCA mutation, without having to know whether this mutation was inherited or is present only in the tumour.
To implement this change, the Determination will amend item 73295 to expand the patient population to patients with advanced (FIGO stage III-IV) high-grade ovarian epithelial, fallopian tube or primary peritoneal for testing of the blood (germline testing) to detect BRCA1 or BRCA2 pathogenic or likely pathogenic variants, where tumour testing is not feasible. The reference to gene mutations has also been updated to reference pathogenic or likely pathogenic variants to reflect current clinical terms.
New item 73301 will be introduced for testing of the tumour tissue (somatic testing) to detect BRCA1 or BRCA2 pathogenic or likely pathogenic variants, in a patient with advanced (FIGO stage III-IV) high-grade ovarian epithelial, fallopian tube or primary peritoneal cancer.
New item 73302 will be introduced to determine whether the presence of somatic BRCA markers, which are to be detected by item 73301, are the result of a hereditary (‘germline’) pathogenic or likely pathogenic BRCA1 or BRCA2 variant. This will further inform the clinician who may recommend testing of the patient’s family members based on the test result.
The proposal to amend item 73295 and to include two new items to expand access to olaparib was supported by MSAC in November 2019 and by PBAC in March 2020.
Consultation
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.
As part of the MSAC process, consultation was undertaken with key stakeholders, clinical experts and providers, and consumer health representatives.
Details of the Determination are set out in the Attachment.
The Determination commences on 1 August 2020.
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 Co-Dependent Pathology Services) Amendment Determination (No. 5) 2020
Section 1 – Name
Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination (No. 5) 2020.
Section 2 – Commencement
Section 2 provides that the Determination commences on 1 August 2020.
Section 3 – Authority
Section 3 provides that the 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 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 Determination has effect according to its terms.
Schedule 1 – Amendments
Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 (the Principal Determination)
Item 1 – Schedule 1 (item 73295)
Item 1 repeals and substitutes item 73295 with an amended descriptor to specify that the service is for patients with advanced (FIGO III-IV) high-grade serous or high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer, and that the service is for patients for whom testing of tumour tissue is not feasible.
Item 2 – Schedule 1 (immediately after item 73295)
Item 2 inserts two new genetic testing items 73301 and 73302 after item 73295. Item 73301 is for testing of the tumour tissue to detect BRCA1 or BRCA2 pathogenic or likely pathogenic variants, in a patient with advanced (FIGO stage III-IV) high-grade ovarian epithelial, fallopian tube or primary peritoneal cancer. This item is to be requested by a specialist or consultant physician.
Item 73302 is to determine whether the presence of somatic BRCA markers are the result of a hereditary pathogenic or likely pathogenic BRCA1 or BRCA2 variant. This item is to be requested by a specialist or consultant physician.
Item 3 – Schedule 1 (item 73344, column 2)
Item 3 amends the descriptor of item 73344 by removing the words “crizotinib” and substituting with “crizotinib or entrectinib”. This will effectively add the treatment option of entrectinib to item 73344, in addition to crizotinib.
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. 5) 2020
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. 5) 2020 (the Determination) is to amend the Health Insurance (Section 3C
Co-Dependent Pathology Services) Determination 2018. This amendment will enable the addition of entrectinib to Medicare Benefits Scheme (MBS) item 73344, and to amend item 73295 and list two new items 73301 and 73302 to expand testing for access to olaparib to patients who have BRCA variants detected, regardless of whether the BRCA variants are the result of germline variant/s or not.
Addition of entrectinib to item 73344
Item 73344 commenced on 1 January 2019 for fluorescent in situ hybridisation (FISH) testing for ROS proto-oncogene 1 (ROS1) rearrangements in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), to determine access to crizotinib under the Pharmaceutical Benefits Scheme (PBS).
The addition of entrectinib to item 73344 will facilitate access to an additional PBS listed treatment for eligible patients with ROS1-positive NSCLC. The Determination will amend item 73344 to enable testing for the ROS1 gene rearrangement by FISH to determine eligibility for newly PBS-subsidised entrectinib, in addition to crizotinib.
This proposal was supported by the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2020 and the Medical Services Advisory Committee (MSAC) in April 2020.
Amendment to item 73295 and introduction of new items 73301 and 73302
Item 73295 commenced on 1 February 2017 for the detection of germline BRCA1 and BRCA2 mutation in selected patients with relapsed ovarian fallopian tube or primary peritoneal cancer with continued sensitivity to platinum-based chemotherapy, to inform eligibility for olaparib under the PBS.
Item 73295 is currently available to patients with ovarian, fallopian tube or primary peritoneal cancer whose cancer has come back (relapsed) after initial response to treatment. Subsequent treatment after the first treatment that either was not effective or is no longer effective is called second-line treatment. Patients with ovarian fallopian tube or primary peritoneal cancer can be tested to see if they have a germline BRCA gene mutation, and if they do they can get olaparib as second-line treatment. However, a service under 73295 cannot be provided for testing of BRCA genes for mutations in a sample from the tumour.
Genetic testing is the only way to confirm if someone has a gene mutation. Genetic testing can be done on a blood sample to determine if the mutation is inheritable (germline testing). It can also be done on a sample from the tumour, which can be taken during surgery, to determine what mutations are present in the tumour (somatic testing).
From 1 August 2020, patients with epithelial ovarian, fallopian tube or primary peritoneal cancer will be able to access the MBS to detect both somatic and germline BRCA1 or BRCA2 variants, to determine eligibility to access olaparib. This will enable the testing for BRCA mutations in tumour samples from patients with these cancers, enabling access to olaparib as a second-line treatment. Access to olaparib may assist patients with ovarian fallopian tube or primary peritoneal cancer and a BRCA mutation, without having to know whether this mutation was inherited or is present only in the tumour.
To implement this change, the Determination will amend item 73295 to expand the patient population to patients with advanced (FIGO stage III-IV) high-grade ovarian epithelial, fallopian tube or primary peritoneal for testing of the blood (germline testing) to detect BRCA1 or BRCA2 pathogenic or likely pathogenic variants, where tumour testing is not feasible. The reference to gene mutations has also been updated to reference pathogenic or likely pathogenic variants to reflect current clinical terms.
New item 73301 will be introduced for testing of the tumour tissue (somatic testing) to detect BRCA1 or BRCA2 pathogenic or likely pathogenic variants, in a patient with advanced (FIGO stage III-IV) high-grade ovarian epithelial, fallopian tube or primary peritoneal cancer.
New item 73302 will be introduced to determine whether the presence of somatic BRCA markers, which are to be detected by item 73301, are the result of a hereditary (‘germline’) pathogenic or likely pathogenic BRCA1 or BRCA2 variant. This will further inform the clinician who may recommend testing of the patient’s family members based on the test result.
This proposal was supported by MSAC in November 2019 and by PBAC in March 2020.
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.
Analysis
This instrument advances the right to health and the right to social security with the addition of entrectinib to item 73344, which will allow an additional PBS listed treatment option for ROS1-positive patients with locally advanced or metastatic NSCLC.
This instrument also expands access to the treatment to olaparib for patients with high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who have BRCA1 or BRCA2 variants detected, regardless of whether the BRCA variants are the result of germline variant/s or not. This is implemented by amending item 73295 and listing new item 73301. New item 73302 is also introduced to determine whether the presence of somatic BRCA markers are the result of a hereditary pathogenic BRCA1 or BRCA2 variant. This will further inform the clinician who may recommend testing of the patient’s family members based on the test result.
Conclusion
This instrument is compatible with human rights as it advances the right to health and the right to social security.
Mary Warner
Acting Assistant Secretary
MBS Policy and Specialist Services Branch
Medical Benefits Division
Health Financing Group
Department of Health