FDA, CMS Data-Sharing Gets Jump Start With Biomarker Initiative
The Oncology Biomarker Qualification Initiative could serve as a pilot test for further data collaboration between FDA and CMS
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Oncology biomarker qualification efforts jointly tackled by FDA, the National Cancer Institute and CMS will encompass prospective studies and ongoing clinical trials
The Centers for Medicare & Medicaid Services will use coverage with evidence development only when an agent is highly likely to show benefit in a broader patient population than its labeled indication, CMS Senior Advisor Peter Bach said Dec. 5
FDA is moving ahead with its biomarker validation efforts with the establishment of a consortium with the Pharmaceutical Research & Manufacturers of America and NIH, but the agency has halted an internal biomarker survey in favor of a broader inventory of endpoints