1376.1 - 70 gene signature (MammaPrint) for use in breast cancer to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit

Page last updated: 08 October 2021

Application Detail

Description of Medical Service

Microarray 70 gene signature expression profiling of breast cancer, performed on either core biopsy or surgically resected formalin fixed paraffin embedded histological specimen, to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit.

Description of Medical Condition

Early stage breast cancer.

Reason for Application

New MBS item

Medical Service Type

Investigative medical service

Previous Application Number

1376

Associated Documentation

Application Form

Application Form (PDF 627 KB)
Application Form (Word 656 KB)

PICO Confirmation

-

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 798 KB)
Public Summary Document (Word 467 KB)

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

Meetings for this Application

PASC

12 April 2017

ESC

8-9 February 2018

MSAC

28-29 March 2018
31 March - 1 April 2021
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.