EXPLANATORY STATEMENT
Issued by the Authority of the Minister for Health
Health Insurance Act 1973
Health Insurance (Section 3C Co-Dependent Pathology Services) Amendment Determination
(No. 4) 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The Table is set out in the regulations made under subsection 4A(1) of the Act, which is repealed and remade each year.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 2019.
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. 4) 2020 (the Determination) is to amend the Health Insurance (Section 3C
Co-Dependent Pathology Services) Determination 2018 to enable the addition of “brigatinib” to MBS item 73341, by referring to Pharmaceutical Benefits Scheme (PBS)-subsidised anaplastic lymphoma kinase (ALK) inhibitors (crizotinib, ceritinib, alectinib and brigatinib), as a therapeutic class, rather than listing the individual PBS-subsidised medicines.
Item 73341 commenced on 1 July 2015 for fluorescence in situ hybridisation (FISH) testing of tumour tissues from a patient with locally advanced or metastatic non-small cell lung cancer (NSCLC) for identification of anaplastic lymphoma kinase (ALK) gene rearrangement status by immunohistochemical (IHC) for access to Pharmaceuticals Benefits Scheme (PBS)-subsidised crizotinib. On 1 February 2017 and 6 February 2018, the item was expanded to include testing for access to PBS-listed ceritinib,and alectinib respectively, as treatment options.
The addition of brigatinib to MBS item 73341 will facilitate access to an additional PBS listed ALK inhibitor treatment for eligible patients with NSCLC.
The Determination will amend Medicare Benefits Scheme (MBS) item 73341 to replace the list of individual Pharmaceutical Benefits Scheme (PBS)-subsidised medicines with reference to the therapeutic class - “anaplastic lymphoma kinase inhibitors”. The amendment will enable access to PBS-listed treatment options for a specialist or consultant physician consideration of individual patient circumstances, resulting in optimal care for patients. This amendment was proposed by the Medical Services Advisory Committee (MSAC) in November 2019, in relation to its consideration of the comparative safety, clinical effectiveness and cost-effectiveness of this pathology test for access to the anaplastic lymphoma kinase inhibitor, brigatinib. Brigatinib is scheduled to be listed on the PBS for this purpose, on 1 May 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 May 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. 4) 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. 4) 2020.
Section 2 – Commencement
Section 2 provides that the Determination commences on 1 May 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 73341, column 2)
Item 1 amends the MBS item 73341 descriptor removing the words “crizotinib, ceritinib, or alectinib” and substituting with the words “an anaplastic lymphoma kinase inhibitor”. This will effectively add the treatment option of brigatinib to the three PBS-listed medicines currently specified in the item.
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. 4) 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. 4) 2020 (the Determination) is to amend the Health Insurance (Section 3C Co-Dependent Pathology Services) Determination 2018 to remove the words “crizotinib, ceritinib, or alectinib” and replace with the words “an anaplastic lymphoma kinase inhibitor”. This will effectively add the treatment option of brigatinib to the three PBS-listed medicines currently specified in the item.
MBS Item 73341 commenced on 1 July 2015 for fluorescence in situ hybridisation (FISH) testing of tumour tissue in patients with non-small cell lung cancer (NSCLC) for identification of anaplastic lymphoma kinase (ALK) gene status rearrangement to determine access to Pharmaceuticals Benefits Scheme (PBS)-listed crizotinib. On 1 February 2017 and 6 February 2018, the item was expanded to include access to ceritinib and alectinib, respectively, as treatment options for patients with locally advanced or metastatic NSCLC.
On 6-8 November 2019 the Pharmaceutical Benefits Advisory Committee (PBAC) evaluated brigatinib and recommended its use as monotherapy as a treatment option for patients with locally advanced or metastatic NSCLC, where FISH testing has identified ALK rearrangements. The corresponding proposal requesting amendment of MBS item 73341 to include brigatinib as one of the PBS listed medicines for which FISH testing of tumour tissue is used to detect anaplastic lymphoma kinase (ALK) gene rearrangement status, was supported by the Medical Services Advisory Committee (MSAC) at the meeting on 28-29 November 2019. MSAC also recommended that MBS item 73341 be amended to refer to “an anaplastic lymphoma kinase inhibitor”, replacing the current list of PBS-listed medicines in this MBS item and circumventing the need to specify the additional treatment, brigatinib.
The Determination will amend MBS item 73341 to describe the testing of tumour tissue by FISH to determine if PBS requirements relating to ALK gene rearrangement status are fulfilled, to provide access to PBS-listed ’anaplastic lymphoma kinase inhibitors’. These amendments to MBS item 73341 will allow an additional treatment option to be available to clinicians in consideration of individual patient circumstances with locally advanced or metastatic NSCLC, resulting in optimal care for patients.
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 effective addition of brigatinib to MBS item 73341. The addition of brigatinib to the existing list of PBS-subsidised ALK inhibitors (i.e. crizotinib, ceritinib and alectinib) currently specified in MBS item 73341, will be facilitated by replacing the individual drug names with the term ‘an anaplastic lymphoma kinase inhibitor’. This will allow expanded PBS listed treatment options for patients with locally advanced or metastatic NSCLC.
Conclusion
This instrument is compatible with human rights as it maintains the right to health and the right to social security.
Renaye Lucchese
Acting Assistant Secretary
Diagnostic Imaging and Pathology Branch
Medical Benefits Division
Health Financing Group
Department of Health