1457 PD-L1 (Programmed Death 1 Ligand) IHC (immunohistochemistry) testing for access to pembrolizumab as first-line therapy for patients with unresectable or metastatic bladder cancer ineligible for cisplatin-based therapy.

Page last updated: 08 July 2020

Application Detail



Description of Medical Service

It is proposed that immunohistochemistry (IHC) test for evaluation of Programmed Cell Death- Ligand 1 (PD-L1) expression to determine eligibility for treatment with pembrolizumab, be undertaken in patients diagnosed with unresectable or metastatic bladder cancer. The tissue removed as part of a standard biopsy 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, and it would be proposed that the test is a pathologist determinable test.

Description of Medical Condition

Stage IV advanced/metastatic bladder cancer. Patients with stage IV bladder cancer have cancer that has extended through the bladder wall and invaded the pelvic and/or abdominal wall and/or has lymph node involvement and/or spread to distant sites. Stage IV bladder cancer is also referred to as “unresectable or metastatic” bladder cancer.

Reason for Application

New MBS item

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application form (PDF 275 KB)
Application form (Word 541 KB)

PICO Confirmation

PICO Confirmation (PDF 349 KB)
PICO Confirmation (Word 693 KB)

Assessment Report


Public Summary Document


Meetings for this Application


8 December 2016