Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017

Administered by Department of Health, Disability and Ageing

Legislation au F2017L01542 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

 

Issued by the Authority of the Minister for Health

 

Health Insurance Act 1973

 

Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017

 

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 Health Insurance (Pathology Services Table) Regulations which is remade each year.  The current Regulation is the Health Insurance (Pathology Services Table) Regulation 2017.  

 

Purpose

The Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Determination 2017 enables certain patients to be tested for 17p chromosomal deletions on the Medicare Benefits Schedule (MBS) as provided under Item 73343 in Schedule 1 to that Determination. Patients with a positive test are eligible to access the drug idelalisib on the Pharmaceutical Benefits Scheme (PBS).

 

The purpose of the Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017 (the Determination) is to amend the Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Determination 2017 to allow patients who tested positive for the 17p chromosomal deletions to access idelalisib or ibrutinib on the PBS from 1 December 2017.

 

In March 2017, the Pharmaceutical Benefit Advisory Committee (PBAC) recommended the listing of ibrutinib for use in patients who met certain conditions for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). In April 2017, the Medical Services Advisory Committee (MSAC) supported the recommendation of PBAC.

 

The Government has approved the listing of ibrutinib on the PBS from 1 December 2017 for the treatment of eligible patients with relapsed or refractory CLL or SLL. Ibrutinib will provide an additional treatment option for eligible patients, and PBAC considered that for some patients, ibrutinib provides a significant improvement in effectiveness compared to current treatments.

 

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.

 

Consultation was previously undertaken with the Royal College of Pathologists Australasia, and the Pathology Clinical Committee were provided status updates in relation to item 73343, as part of the MSAC process.

 

Details of the Determination are set out in the Attachment.

The Determination commences on 1 December 2017.

 

The Determination is 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 Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017

 

Section 1 – Name of Determination

 

Section 1 provides for the Determination to be referred to as the Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017.

 

Section 2 – Commencement

 

Section 2 provides that the Determination commences on 1 December 2017.

 

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 the Schedule to the Amendment Determination amends the instrument specified in the Schedule. The Schedule specifies the Health Insurance (Section 3C Pathology Services – 17p Deletion Testing) Determination 2017.

Schedule 1 – Amendment

Item 1 amends the item descriptor of item 73343 by inserting ibrutinib. From 1 December 2017, patients with a positive test for 17p chromosomal deletions will be eligible for idelalisib or ibrutinib on the Pharmaceutical Benefits Scheme.

 

 

 


Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017

 

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 (Section 3C Pathology Services—17p Deletion Testing) Determination 2017 enables certain patients to be tested for 17p chromosomal deletions on the Medicare Benefits Schedule (MBS). Patients with a positive test are eligible to access to idelalisib on the Pharmaceutical Benefits Scheme (PBS).

 

The purpose of the Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017 (the Determination) is to amend the Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Determination 2017 to allow patients with a positive test for 17p chromosomal deletion to access idelalisib or ibrutinib on the PBS from
1 December 2017.

 

The Government has approved the listing of ibrutinib on the PBS from 1 December 2017 for the treatment of eligible patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). Ibrutinib will provide an additional treatment option for eligible patients. The Pharmaceutical Benefit Advisory Committee considered that for some patients, ibrutinib provides a significant improvement in effectiveness compared to current treatments.

Human rights implications

The Determination 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 Determination will maintain or advance rights to health and social security by ensuring access to publicly subsidised health services which are clinically effective and cost-effective.

Conclusion

This Determination is compatible with human rights as it has a positive effect on human rights issues.

 

Celia Street

Assistant Secretary

Diagnostic Imaging and Pathology Branch

Medical Benefits Division

Department of Health

 

Overview

The Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017 amends the Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Determination 2017 under the authority of subsection 3C(1) of the Health Insurance Act 1973. This Amendment Determination was introduced to address the need to provide patients with access to the drug ibrutinib on the Pharmaceutical Benefits Scheme (PBS) from 1 December 2017, following its approval by the Pharmaceutical Benefit Advisory Committee in March 2017 and the Government's subsequent decision to list it for eligible patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma. The policy objective of this Amendment Determination is to ensure that patients who test positive for 17p chromosomal deletions are eligible for either idelalisib or ibrutinib on the PBS, thus enhancing their access to effective treatment options. This legislative instrument was enacted by the Australian Government, specifically under the authority of the Minister for Health, to align with the broader health policy of providing equitable access to essential medical treatments. The Determination was developed following consultations with relevant medical advisory bodies, ensuring that the amendments are both clinically effective and cost-effective. The overall aim is to improve patient outcomes by facilitating timely access to necessary medications, thereby advancing the rights to health and social security as recognised under international human rights instruments.

Scope and Application

The Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017 amends the Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Determination 2017 under subsection 3C(1) of the Health Insurance Act 1973. This Amendment Determination aims to expand access to certain treatments for patients who test positive for 17p chromosomal deletions. Specifically, from 1 December 2017, it allows these patients to access ibrutinib, in addition to idelalisib, on the Pharmaceutical Benefits Scheme (PBS) for the treatment of relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The Amendment Determination applies to patients in Australia who are eligible for Medicare and need specific pathology services, ensuring they can access these critical treatments under the PBS. The Determination's application is underpinned by recommendations from the Pharmaceutical Benefit Advisory Committee and the Medical Services Advisory Committee, which support the inclusion of ibrutinib for specific medical conditions. This legislative instrument ensures that patients receive appropriate and timely access to treatments that are clinically effective and cost-effective, thus advancing their rights to health and social security as recognised under the International Covenant on Economic, Social and Cultural Rights.

Key Provisions

The Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Amendment Determination (No.2) 2017 amends the existing Health Insurance (Section 3C Pathology Services—17p Deletion Testing) Determination 2017. This amendment, effective from 1 December 2017, allows patients who have tested positive for 17p chromosomal deletions to access ibrutinib, in addition to idelalisib, under the Pharmaceutical Benefits Scheme (PBS) (Section 1 and 4). The amendment ensures that patients with a positive test for 17p chromosomal deletions are eligible for these medications, which are treatments for relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) (Section 4, Schedule 1). The Amendment Determination imposes specific obligations on healthcare providers and patients. Healthcare providers must ensure that eligible patients with a positive test for 17p chromosomal deletions are informed of their eligibility for idelalisib or ibrutinib on the PBS, and they must adhere to the criteria and procedures outlined in the amended determination. Patients, on the other hand, must meet the eligibility criteria and comply with the prescribed conditions for accessing these medications under the PBS. The Determination also requires that the changes be implemented from the specified commencement date of 1 December 2017, ensuring a seamless transition in the provision of these services (Section 2). Failure to comply with the requirements set out in the Amendment Determination may result in legal consequences. While the specific penalties for non-compliance are not detailed in the text, breaches of health-related legislation in Australia can lead to various sanctions, including fines, imprisonment, or both, depending on the severity of the breach. The penalties are designed to enforce compliance and ensure the proper administration of health services and benefits under the PBS and Medicare Benefits Schedule (MBS). Furthermore, non-compliance may also result in civil consequences, such as the revocation of accreditation or the imposition of administrative penalties by relevant health authorities. These measures are intended to maintain the integrity of the health system and protect the rights of patients to access necessary and approved treatments.

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