Applications

1549 – PD-L1 immunohistochemistry testing for access to pembrolizumab in combination with chemotherapy for first line treatment of triple negative breast cancer

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 -
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Supported

Application details

Reason for application

Amendment to MBS item.

Service or technology in this application

It is proposed that immunohistochemistry (IHC) testing be used for the evaluation of Programmed Cell Death- Ligand 1 (PD-L1) expression to determine eligibility for treatment with pembrolizumab in combination with chemotherapy in patients with recurrent inoperable or metastatic triple negative breast cancer. Tissue obtained through core or excisional biopsy at diagnosis of disease will be used for IHC testing of PD-L1 expression (Combined Positive Score >10). The testing would be done by a pathologist alongside other immunohistochemical tests.

Type: Investigative technology

Medical condition this application addresses

Triple negative breast cancer refers to breast cancer that does not present with the three most common types of receptors known to fuel breast cancer growth (estrogen, progesterone, and the human epidermal growth factor receptor 2 gene). This form of cancer tends to be more aggressive than other breast cancer sub-types with a poor prognosis, and is more likely to affect premenopausal women.

Consultation survey and deadlines

  • PASC consultation: Expedited – bypassing PASC
  • MSAC consultation: Closed Friday 10 February 2023

Meetings to consider this application

  • PASC meeting: Bypassing PASC
  • ESC meeting: Bypassing ESC
  • MSAC meeting: 30 to 31 March 2023