Personalized Medicine Meets Payment Policy: MEDCAC Has “Low Confidence” In Most Cancer Tests
This article was originally published in RPM Report
Genomic screening of tumor types may be the cutting edge in cancer treatment and a central component of the President’s vision for personalized medicine. But how much evidence is necessary to make insurance coverage for testing routine?
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CMS remains open to the idea of using parallel review (or, less formal parallel advice) for prescription drugs, but the current and future focus of the pilot program is likely to stay on devices and diagnostics.
Looking Forward At FDA: Hamburg’s Farewell Notes Challenges; Califf’s First Remarks Focus on Pediatrics
FDA Commissioner Margaret Hamburg is leaving the agency on a high note – and taking the opportunity to urge stakeholders to avoid the temptation to push for changes that will “”weaken or undermine” the agency. Meanwhile, FDA's new Deputy Commissioner of Medical Products Robert Califf makes his first formal remarks in that role during a stakeholder meeting on pediatric research.
A “safety focused” advisory committee is never something a sponsor looks forward to. But in the case of FDA’s review of GSK’s new Breo Ellipta asthma inhaler, the outcome was generally positive. In this case, FDA seems more concerned that too much emphasis on safety is steering development aware from an area of significant medical need.