Applications

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

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  • Status Withdrawn
  • Type -
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome -

Application details

Reason for application

New MBS item.

Service or technology in this application

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.

Type: Co-dependent technology

Medical condition this application addresses

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.

Application documents

Meetings to consider this application

  • PASC meeting: 8 December 2016
  • ESC meeting: -
  • MSAC meeting: -