Applications

1783 – Genetic testing to detect PIK3CA mutations in patients with hormone receptor (HR)-positive, HER-2 negative, locally advanced or metastatic breast cancer, to determine eligibility for treatment with PBS subsidised inavolisib

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 -
  • Type New application
  • Pre-PASC consultation Closed
  • Pre-MSAC consultation Not yet started
  • Outcome Pending

Application details

Reason for application

New MBS item (MSAC-PBAC co-dependent submission).

Service or technology in this application

The test is to detect the presence of PIK3CA mutations in tumour tissue using a sample of tumour tissue or circulating tumour DNA (ctDNA) extracted from blood plasma. This test is for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer (a/mBC) who have relapsed on endocrine therapy. This test is to determine eligibility for a potential new PBS subsidised treatment, inavolisib.

Type: Investigative technology

Medical condition this application addresses

Breast cancer is the abnormal growth of cells lining the breast lobules (milk-producing glands) or breast ducts (passages that drain milk from the lobules towards the nipple), or in the fatty and fibrous tissue of the breast. Advanced breast cancer comprises both locally advanced (inoperable) and metastatic disease (a/mBC). Some patients present with a/mBC disease at diagnosis, and many with early breast cancer eventually progress to a/mBC. HR and HER2 describe the receptor subtype of breast cancer which can provide useful information on the patient’s prognosis and how the cells may respond to treatment.

Consultation survey and deadlines

  • PASC consultation: Closed Friday 12 July 2024
    Any consultation received after this date will automatically be included in the MSAC consultation for this application.
  • MSAC consultation: TBA – please subscribe to the MSAC bulletin to be notified when this application is scheduled for MSAC consideration. The bulletin will also advise the closing date for consultation input.

Meetings to consider this application

  • PASC meeting: 15–16 August 2024
  • ESC meeting: -
  • MSAC meeting: -