Application Detail

Description of Medical Service

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.

Description of Medical Condition

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.

Reason for Application

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

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Summary and PICO Set

Application Summary (PDF 169 KB)
Application Summary (Word 27 KB)

Application PICO Set (PDF 637 KB)
Application PICO Set (Word 143 KB)

Consultation Survey

Consultation Survey

PASC Consultation
PASC consultation closed Friday 12 July 2024.

MSAC Consultation
MSAC consultation TBA – please subscribe to the MSAC email bulletin to be notified when this application is scheduled for MSAC consideration. The bulletin will also advise the closing date for consultation input.

For further information please refer to PASC, ESC, MSAC Key Dates

For further information on the consultation proves please refer to MSAC Consultation Process

PICO Confirmation

PICO Confirmation (PDF 1554 KB)

PICO Confirmation (Word 1266 KB)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

15-16 August 2024

ESC

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MSAC

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