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).

Page last updated: 07 November 2017

Application Detail



Description of Medical Service

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.

Description of Medical Condition

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.

Reason for Application

New MBS Item

Medical Service Type


Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (Word 284 KB)
Application Form (PDF 851 KB)

Consultation Survey

Consultation Survey (Word 508 KB)
Consultation Survey (PDF 312 KB)

PICO Confirmation


Assessment Report


Public Summary Document


Meetings for this Application


8 December 2017