Medicare contractor Palmetto GBA has proposed coverage for Guardant Health's 73-gene Guardant360 liquid biopsy test in more than a dozen solid tumor types where biomarker information is needed to inform their treatment.
In a draft local coverage decision issued today, Palmetto said it would cover Guardant360 for advanced solid tumors when tissue-based genomic analysis is not possible or when tissue testing for non-small cell lung cancer hasn't identified actionable mutations. Patients can be eligible for covered testing if they are considering treatment with a drug with a biomarker-defined indication that is US Food and Drug Administration approved or is recommended by the National Comprehensive Cancer Network.
This is the first liquid biopsy genomic profiling assay to receive broad local coverage across multiple solid tumors. Palmetto and other Medicare contractors previously granted local coverage to Guardant360 for patients with advanced non-small cell lung cancer. In moving to expand coverage of the test, Palmetto reasoned that broader access to a liquid biopsy assay may help address the limitations of biomarker-guided treatments informed by tissue-based profiling tests. "Even among patients whose cancers were genomically profiled at diagnosis and found to have a mutation for which they are receiving targeted treatment, resistance to the initial targeted treatment may emerge," Palmetto said. "For some patients, the identification of a new mutation, not present in the original tissue sample and found in the blood, may allow the selection of a new targeted life-prolonging therapy."