1642 – Programmed Death Ligand 1 testing for access to cemiplimab for the treatment of locally advanced or metastatic non-small cell lung cancer

Page last updated: 23 February 2022

Description of medical service

Measurement of Programmed Death Ligand 1 (PD-L1) levels in tumour material from a patient diagnosed with NSCLC to determine if requirements are fulfilled for access to cemiplimab (a PD-1 inhibitor), under the Pharmaceutical Benefits Scheme.

Description of medical condition

The applicant’s response is: ‘Lung cancer is the leading cause of cancer death in Australia and worldwide. At least 50% of lung cancer cases are stage III or IV at diagnosis. The 5-year relative survival for stage III lung cancer is 17.1% and for stage IV only 3.2%. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 85% of all lung cancer cases. The majority of NSCLC lack defined mutations (such as epidermal growth factor receptor and anaplastic lymphoma kinase) that can be targeted by tyrosine kinase inhibitors. NSCLC is most commonly treated with platinum-based chemoradiation and more recently immunotherapies, inhibiting programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1).'

Reason for application

Amendment to existing MBS item 72814

Medical Service Type


Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1336 KB)
Application Form (Word 185 KB)

Consultation Survey

Consultation Survey (PDF 559 KB)
Consultation Survey (Word 70 KB)

PICO Confirmation


Assessment Report


Public Summary Document

Public Summary Document (PDF 390 KB)
Public Summary Document (Word 74 KB)

Meetings for this Application


Expedited – Bypassed PASC


Expedited – Bypassed ESC


25-26 November 2021