Applications

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

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type Re-application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

New MBS item.

Service or technology in this application

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.

Type: Investigative medical service

Medical condition this application addresses

Early stage breast cancer.

Previous applications

1376 – MammaPrint? 70-gene microarray mRNA gene expression profile breast cancer signature to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit.

Application documents

Meetings to consider this application

  • PASC meeting: 12 April 2017
  • ESC meeting: 8 - 9 February 2018
  • MSAC meeting: 
    • 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.