CMS Takes A Look At Alzheimer’s With Lilly's Amyvid In Mind
This article was originally published in RPM Report
The Alzheimer’s drug Amyvid received FDA approval for a narrower indication than the sponsors originally wanted. The limited indication got the imaging agent to market, but now Amyvid faces another challenge on the reimbursement front.
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CMS is proposing to deny coverage of Lilly’s Alzheimer’s “rule-out” diagnostic Amyvid. The decision is important for biopharma manufacturers for several reasons, both as a demonstration that the agency really will refuse to pay for FDA approved drugs—and for how CMS thinks it can actually use its authority to encourage research on effective AD therapies.
The Centers for Medicare & Medicaid Services’ new list of “potential” topics for National Coverage Decisions includes 33 separate ideas, most proposed by the public. Not one is directly related to a biopharma topic. CMS’ coverage team swears it remains interested in drug-related coverage issues—but still, this is one list it is nice not to be on.
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