Clinical Utility Card (CUC) proforma

The CUC proforma is modelled on the clinical utility gene card format used by EuroGentest. When completed, a CUC provides relevant information regarding the clinical utility of genetic testing of relevant heritable mutations in particular circumstances, grouped by disease area.

Clinical Utility Card proforma (PDF 180 KB)
Clinical Utility Card proforma (Word 101 KB)

Clinical Utility Card glossary (PDF 112 KB)
Clinical Utility Card glossary (Word 79 KB)

Integrated codependent submissions for tumour-agnostic or pan-tumour cancer medicines

The MSAC Executive has commissioned and endorsed the following two complementary documents to provide context and background into the emerging area of testing biomarkers to help determine eligibility for cancer medicines to be used in metastatic cancer across solid tumour types. Although primarily directed at one such example, these documents are also intended to help applicants and assessment groups consider those aspects which might also be relevant to other examples in this emerging area.

Discussion paper on pan-tumour biomarker testing to determine eligibility for targeted treatment
Discussion paper (PDF 1524 KB)
Discussion paper (Word 304 KB)

A review of the current testing methodologies for the detection of mismatch repair deficiency in tumours
Review paper (PDF 902 KB)
Review paper (Word 85 KB)

MSAC Position Statement on programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) testing for determining patient eligibility for treatment with PD-(L)1 checkpoint inhibitors

MSAC has ratified its Position Statement on programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) testing for determining patient eligibility for treatment with PD (L)1 checkpoint inhibitors. The Position Statement outlines MSAC’s views on the place of PD-L1 IHC testing to help determine eligibility for PD-(L)1 checkpoint inhibitors. The Position Statement enables applicants to lodge streamlined codependent submissions requesting subsidy for PD-L1 IHC testing on a case-by-case basis.

Applicants wishing to seek Medicare Benefits Schedule (MBS) listing of PD-L1 IHC testing to determine eligibility for treatment with PD-(L)1 checkpoint inhibitors should lodge an MSAC Application Form that addresses the rationale for PD-L1 IHC testing and address the clinical utility and analytical performance considerations in this Position Statement.

MSAC Position Statement on PD-L1 immunohistochemistry testing to determine eligibility for treatment with PD-(L)1 checkpoint inhibitors
Position statement (PDF 386 KB)
Position statement (Word 106 KB)