Health Evidence Review Commission (herc) Coverage Guidance: Biomarker Tests of Cancer Tissue for Prognosis and Potential Response to Treatment

Oncotype DX is recommended for coverage in early stage breast cancer when used to guide adjuvant chemotherapy treatment decisions for women who are lymph node negative (strong recommendation). The following genetic tests of cancer tissue are recommended for coverage (strong recommendation):  BRAF gene mutation testing for melanoma  Epidermal growth factor receptor (EGFR) gene mutation testing for non-small-cell lung cancer  KRAS gene mutation testing for colorectal cancer The following genetic tests of cancer tissue are not recommended for coverage (weak recommendation):  Mammaprint, ImmunoHistoChemistry 4 (IHC4), and Mammostrat for breast cancer  Prolaris and Oncotype DX for prostate cancer  BRAF, microsatellite instability (MSI), and Oncotype DX for colorectal cancer  KRAS for lung cancer  Urovysion for bladder cancer  Oncotype DX for lymph node-positive breast cancer The use of multiple molecular testing to select targeted cancer therapy is not recommended for coverage (weak recommendation).