BRAF V600 Variant Testing
BRAF V600 variant testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy may be considered medically necessary in the following circumstances:
Individuals with unresectable or metastatic melanoma.
AND
The individual does not have any U.S. Food and Drug Administration (FDA)-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.
Analysis of tumor tissue for the somatic BRAF V600 variant to select individuals for immune checkpoint inhibitor therapy is considered investigational in all other situations.
Mismatch Repair/Microsatellite Instability Testing
Mismatch repair/microsatellite instability (MMR/MSI) testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy may be considered medically necessary in the following circumstances:
Individuals with advanced or metastatic colorectal cancer; OR
Individuals with advanced endometrial carcinoma who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation; OR
Individuals with unresectable or metastatic solid tumors who have progressed following prior treatment and who have no satisfactory alternative treatment options.
