Supporting a National Coverage Determination Request for an Innovative Cancer Treatment

On March 16, 2018, the Centers for Medicare & Medicaid Services (CMS) took a major step forward in enabling precision medicine for the treatment of patients with cancer. Specifically, CMS issued a final National Coverage Determination (NCD) that allows patients to receive U.S. Food and Drug Administration (FDA)-approved next-generation sequencing (NGS) tests for any recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer. NGS tests can be used to sequence the DNA from tumor tissue, allowing care providers to test for a large number of genomic alterations that are implicated in cancer cell biology. Collectively, the results can help physicians make more informed and individualized decisions about a patient's treatment regimen, which can lead to improved treatment response rates and survival. Following the NCD, all Medicare-eligible patients who are diagnosed with advanced solid tumor cancer in the United States each year may become eligible for tumor sequencing using NGS.

Among the tests approved for coverage was FoundationOne CDx™, the first comprehensive genomic profiling assay reviewed simultaneously by the CMS and FDA for solid tumors through a parallel process. Developed by Foundation Medicine, the 324-gene panel test can detect genomic alterations across all solid tumor types, including alterations associated with over 15 already-approved targeted cancer drugs, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB). 

An Analysis Group team, led by Senior Advisor Anita Chawla and Manager Marcia Reinhart, supported Foundation Medicine's NCD request with a comprehensive review and synthesis of medical and scientific information on advanced cancer and settings in which FoundationOne CDx is expected to be used, the analytic and clinical validity of the test, and the clinical utility of NGS-based testing.