1570 - PD-L1 (Programmed Death Ligand 1) immunohistochemistry (IHC) testing for access to atezolizumab as first line therapy for patients with locally advanced or metastatic triple-negative breast cancer (TNBC)

Page last updated: 03 March 2021

Application Detail

Description of Medical Service

The proposed medical service is an IHC test for evaluation of PD-L1 expression to determine eligibility for treatment with atezolizumab in patients with locally advanced or metastatic TNBC who are previously untreated in the advanced setting. The biopsy sample taken as part of a standard diagnostic process will be used for immunohistochemical testing with PD-L1. The testing would be done by a pathologist alongside other immunohistochemical tests which are done routinely.

Description of Medical Condition

Breast cancer is the most frequently diagnosed cancer among women and is the leading cause of cancer related deaths in women word-wide (1, 2). Triple negative breast cancer, a distinct subtype of breast cancer with the worst prognosis, is characterised immunohistologically by the lack of expression of hormonal estrogen receptor (ER) and progesterone receptor (PgR) and lack of overexpression and/or amplification of the human epidermal growth factor 2 (HER2)/NEU gene (3).

Reason for Application

New MBS item(s)

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (Word 118 KB)
Application Form (PDF 789 KB)

Consultation Survey

Consultation Survey (Word 70 KB)
Consultation Survey (PDF 394 KB)

PICO Confirmation

PICO Confirmation (Word 469 KB)
PICO Confirmation (PDF 1315 KB)

Assessment Report


Public Summary Document

Public Summary Document (Word 226 KB)
Public Summary Document (PDF 742 KB)

Meetings for this Application


11 April 2019


13-14 February 2020


3 April 2020
31 March - 1 April 2021