1486 - Programmed cell death ligand 1 (PD-L1) testing to determine PBS access to durvalumab or durvalumab/tremelimumab as 1st line therapy for patients with advanced or metastatic non-small-cell lung cancer (NSCLC)

Page last updated: 24 August 2018

Application Detail



Description of Medical Service

PD-L1 is expressed on tumour cells in a broad range of cancer types, including lung cancer. PD-L1 aids cancers in evading detection and elimination by the immune system by supressing the anti-tumour T cell response. Anti-PD-L1 antibodies can be used therapeutically to enhance anti-tumour immune responses in patients with cancer.
IMFINZI™ (durvalumab, MEDI4736) is a human monoclonal antibody that inhibits binding of PD-L1 to programmed cell death receptor 1 (PD-1). Durvalumab prevents PD-L1 from interacting with its receptors, thus relieving its immunosuppressive effects and enhancing the cytotoxic activity of anti-tumour T cells. Tremelimumab (MEDI1123) is a human monoclonal antibody of the IgG2 kappa subclass which specifically binds to cytotoxic T-lymphocyte antigen -4 (CTLA-4). Upon binding to one of the B7 ligands (CD86 or CD80), CTLA-4 inhibits T cell activity during the early stages of T cell activation. Tremelimumab blocks CTLA-4, prolonging T cell activation and proliferation and enhancing T cell anti-tumour activity. Targeting both the PD-1 and CTLA-4 pathways may have additive or synergistic activity because the mechanisms of action of the PD-1 and CTLA-4 pathways are non-redundant.
The level of PD-L1 gene expression can be assessed using immunohistochemical (IHC) testing with antibodies that bind specifically to the PD-L1 expressed on tumour cells. Several commercial PD-L1 testing kits are now available in Australia. PD-L1 testing is also being conducted to support cancer clinical trials or for research purposes at pathology laboratories in major cancer research hospitals/institutions in Australia.
This application is a co-dependent request for MBS listing of PD-L1 testing to determine which advanced or metastatic NSCLC patients have a high level of PD-L1 gene expression (defined as PD-L1 ≥25%) in order to qualify for requested PBS access to 1st line durvalumab monotherapy treatment, and which advanced or metastatic NSCLC patients have a low level of PD-L1 gene expression (defined as PD-L1 <25%) in order to qualify for requested PBS access to 1st line durvalumab/tremelimumab combination treatment.

Description of Medical Condition

Lung cancer is the fourth most commonly diagnosed cancer in Australia and is also the leading cause of cancer-related death. Lung cancer also has significant morbidity as it has the fourth highest non-fatal cancer disease burden [7.2% of disability-adjusted life years (DALYs) lost]. The 5-year relative survival for lung cancer remains low at 13.8% for males and 18.7% for females. There have been improvements in the diagnosis and clinical management of early stage lung cancer, however the majority of patients (approximately 60%) are still diagnosed with advanced stage disease. New treatments for patients with genetic targets such as Epidermal Growth Factor Receptor (EGFR) mutations and Anaplastic Lymphoma Kinase (ALK) rearrangements have improved outcomes for these patients. For patients with advanced or metastatic NSCLC who do not have these mutations the prognosis remains poor, and the development of new treatments continues to be an area of high unmet medical need.

Reason for Application

New MBS item(s)

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form


Consultation Survey


PICO Confirmation


Assessment Report


Public Summary Document


Meetings for this Application


11 August 2017