Applications

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

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 Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Supported

Application details

Reason for application

Amendment to existing MBS item 72814.

Service or technology in this application

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.

Type: Investigative

Medical condition this application addresses

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).'

Meetings to consider this application

  • PASC meeting: Expedited – bypassed PASC
  • ESC meeting: Expedited – bypassed ESC
  • MSAC meeting: 25 to 26 November 2021