CMS Jumps Out Ahead Of FDA With Transcatheter Valve Coverage Analysis
This article was originally published in The Gray Sheet
Executive SummaryEdwards Lifesciences is still waiting on an approval decision from FDA on the first indication for its Sapien transcatheter aortic heart valve replacement, but CMS has decided not to wait.
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New Medicare coverage policy for transcatheter aortic valve replacement is a significant step for the nascent procedure and a possible window into how the agency will address future high-profile, early-stage technologies.
CMS’ proposed national coverage determination comes only three months after the approval and launch of Edwards Lifesciences’ Sapien, the first transcatheter aortic valve in the U.S. It restricts coverage to FDA-approved indications and includes a coverage-with-evidence-development provision.
The non-randomized continued access program, which enrolled 822 transapical patients beyond the original randomized enrollment of 104 transapical patients, tells an improving story for transapical delivery for Sapien.