Application Detail
Description of Medical Service
Genetic testing, by Next Generation Sequencing (NGS), of tumour tissue from patients with specific types of breast cancer (see below) who have had recurrence or progression of disease on or after a type of treatment called endocrine therapy. The testing is to determine whether there have been alterations to the AKT Pathway in the tumour, which could change how the tumour behaves and could be the reason that the tumour was resistant to endocrine treatment. The results of the test will determine whether the patient will be eligible for treatment with PBS subsidised capivasertib.Description of Medical Condition
The medical service is proposed for patients with breast cancer that has been categorised as Hormone Receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative, and who have recurrent, unresectable, or metastatic breast cancer who have relapsed on endocrine therapy.One of the reasons tumours might be resistant to endocrine therapy is the activation of the AKT Pathway, a signalling pathway causing tumour growth, and relapse of disease.
The genes involved are PIK3CA, AKT, and PTEN. AKT Pathways activation includes:
- Activating mutations in PIK3CA or AKT1 which can inappropriately activate the pathway.
- Loss of function mutations in PTEN which can lead to unregulated signalling
Reason for Application
New MBS item (MSAC-PBAC co-dependent submission)Medical Service Type
Investigative technologyPrevious Application Number/s
Not ApplicableAssociated Documentation
Application Summary and PICO Set
Application Summary (PDF 384 KB)Application Summary (Word 23 KB)
PICO Set Document (PDF 1041 KB)
PICO Set Document (Word 499 KB)
Consultation Survey
Consultation Survey (PDF 655 KB)Consultation Survey (Word 32 KB)
PASC Consultation
PASC consultation closes 15 March 2024
MSAC Consultation
MSAC consultation TBA – please subscribe to the MSAC Email Bulletin to be notified when consultation opens for this application
For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process