Medicare Finalizes NGS Test Coverage For Advanced Cancers, Drops Evidence-Collection Provision
The US Centers for Medicare and Medicaid Services said on March 16 that it will cover next-generation sequencing diagnostic laboratory tests for advanced cancers, broadening its final determination to cover use in relapsed, refractory and stage III cancers, while dropping "coverage with evidence development" conditions.
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The CMS opened a national coverage analysis tracking sheet on 29 April to reconsider evidence for next-generation sequencing tests of germline mutations. These assays identify beneficiaries with hereditary cancer who may benefit from targeted treatments based on the tests’ conclusions about carcinogenic genetic mutations passed on by patients’ parents.
There are changes afoot in the regulation and reimbursement policy for IVDs in the EU and US. When it comes to personalized medicine, and companion diagnostics in particular, are the two markets becoming more polarized? Medtech Insight asked US- and EU-based attorneys at Hogan Lovells.
Loxo impressed at ASCO last year with larotrectinib, which has now been accepted by FDA for priority review with a PDUFA date of Nov. 26, and the oncology drug developer could shine again this year. If approved, however, larotrectinib could launch ahead of its companion diagnostic.