Somatic Biomarker Testing for Immune Checkpoint Inhibitor Therapy (BRAF, MSI/MMR, PD-L1, TMB)

Multiple biomarkers are being evaluated to predict response to immunotherapy for individuals with cancer. Immune checkpoint inhibitors and associated companion diagnostic tests for these therapies have received U.S. Food and Drug Administration approval for cancer-specific and, more recently, tumor agnostic indications. Extensive evidence review is not included for somatic tests of individual genes (not gene panels) associated with U.S. Food and Drug Administration (FDA)-approved therapeutics (ie, as companion diagnostic tests) for therapies with National Comprehensive Cancer Network (NCCN) recommendations of 2A or higher. Pivotal evidence is included in Table 1 for informational purposes. Additionally, no evidence review is provided for somatic tests of individual genes that do not have associated FDA-approved therapies regardless of NCCN recommendations, as these off-label therapies are deemed investigational per the Blue Cross and Blue Shield Association Medical Policy Program Policies and Procedures.