1408 - A prognostic RT-qPCR test run locally for ER+ve /HER2-ve breast cancer that determines the risk of early and late metastasis in node negative and positive cancer under endocrine treatment.

Page last updated: 08 October 2021

Application Detail

Description of Medical Service

An application was received for public funding through the Medicare Benefits Schedule (MBS) for a type of genetic testing. The test, called EndoPredict, is claimed to help determine the risk of a patient getting breast cancer again after they have had surgery.

Description of Medical Condition

Patients with ER positive and HER2 negative breast cancer following surgery.

Currently, combining information from clinical assessments and pathology test results helps doctors calculate whether a patient has a low, intermediate or high risk of breast cancer returning after surgery. This helps the patient decide, with their treating clinicians, whether to have chemotherapy in addition to their hormone therapy. The applicant claims that this decision is most difficult for patients whose existing information shows they have an intermediate risk of the cancer returning and that the EndoPredict genetic test can then provide valuable extra information to help this group of patients.

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

Final Protocol (PDF 2940 KB)
Final Protocol (Word 245 KB)

Assessment Report

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Public Summary Document

Public Summary Document (PDF 576 KB)
Public Summary Document (Word 205 KB)

MSAC minutes - July 2021 (PDF 212 KB)
MSAC minutes - July 2021 (Word 69 KB)

Meetings for this Application

PASC

13 August 2015

ESC

10-11 October 2019

MSAC

28-29 November 2019
29-30 July 2021

Stakeholder Meeting

The Royal College of Pathologists of Australasia (RCPA), together with the Department of Health and Cancer Australia, hosted a workshop on 21 June 2021 to discuss options for publicly funded access to gene expression profiling (GEP) tests in Australia. Participants also included representatives from consumer organisations, clinicians with experience and expertise in breast cancer, pathology and clinical genetics, and representatives of the four current GEP test providers (Endopredict®, MammaPrint®, Oncotype DX®, Prosigna®). The outcome of this workshop was that GEP test providers were invited to lodge focussed applications to support the prognostic value of GEP tests; the focussed application should also address Therapeutic Goods Administration (TGA) registration, the Department’s proposed Medicare Benefits Schedule (MBS) item fee consistent with prognostic value, and provide a proposed MBS item descriptor. Focussed applications were received for EndoPredict from Myriad Genetics Pty Ltd, MammaPrint from Genome Investigation Pty Ltd and Prosigna from Veracyte, Inc.

As part of the appraisal process for these focussed applications, the Department also invited input from a range of stakeholders through public consultation, primarily facilitated by workshop participants. Individuals or organisations with an interest in this application, including lived experience of the health conditions and/or treatment that the application is addressing, were able to provide input by the deadline of 12 July 2021.

Focussed applications and public consultation feedback were considered by the Medical Services Advisory Committee (MSAC) at its 29-30 July 2021 meeting. The MSAC Minutes for the GEP test applications are published above.