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

Page last updated: 30 June 2022

Application Detail

Description of Medical Service

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

Description of Medical Condition

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.

Reason for Application

Amendment to MBS item

Medical Service Type

Investigative technology

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1297 KB)
Application Form (Word 171 KB)

Consultation Survey

Consultation Survey (PDF 659 KB)
Consultation Survey (Word 27 KB)

PASC Consultation
Expedited - Bypassing PASC

MSAC Consultation
MSAC consultation input closed Friday, 10 February 2023.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation


Assessment Report


Public Summary Document

Public Summary Document (PDF 802 KB)
Public Summary Document (Word 793 KB)

Meetings for this Application


Bypassing PASC


Bypassing ESC


30-31 March 2023