1505 – Programmed cell death ligand 1 (PD L1) testing in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) to determine eligibility for durvalumab monotherapy or durvalumab/tremelimumab combination therapy (co dependent)

New MBS Item.

By expressing programmed cell death ligand 1 (PD L1) on its surface, a tumour cell can evade detection and destruction by the body’s innate immune system. PD L1 expression exists on a spectrum ranging from not detectable to (theoretically) 100% expression. A PD L1 test involves taking a biopsy of the tumour and performing an immunohistochemical (IHC) assay to detect the percentage of PD L1 expression within a tumour, measured as a total proportion score (TPS).

This application requests MBS listing of PD-L1 testing to direct treatment to either monotherapy with the PD-L1 inhibitor durvalumab, or combination therapy with durvalumab and tremelimumab, a CTLA-4 inhibitor, in patients with unresectable recurrent or metastatic SCCHN. Although trials are ongoing, it is expected that patients with a higher (≥25%) PD-L1 expression rate will benefit from monotherapy, while those with a lower (<25%) expression rate will benefit more from combination therapy. Co-dependent PBAC/MSAC submissions are expected to follow this application.

Type: Therapeutic

SCCHN is a form of cancer arising from the squamous cells of various structures including the mouth, tongue, pharynx, larynx and oesophagus. It is associated with smoking, alcohol consumption and poor oral health. In recent years, human papilloma virus (HPV) has also been identified as a cause of SCCHN. HPV related cases are steadily increasing in prevalence. Patients with HPV related SCCHN tend to be younger and have a better prognosis than those whose cancers have other causes.

SCCHN can be disfiguring, particularly in advanced disease. Surgery and radiotherapy offer the best options for treatment, but surgery can be complicated because of the location of the tumours, and may require partial neck dissection which can leave significant scarring. In the case of recurrent tumours, multiple surgeries and radiotherapies can be contraindicated. Because of this, medical treatments are sometimes the preferred option in recurrent or metastatic SCCHN.

• PASC meeting: 8 December 2017
• ESC meeting: -
• MSAC meeting: -