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CMS wants more data from Lilly before it reimburses for Alzheimer’s imaging agent
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Eli Lilly’s Amyvid, an Alzheimer’s disease screening agent, has been rejected for Medicare reimbursement unless patients are enrolled in clinical trials, according to a CMS draft decision.
Amyvid (florbetapir F 18 injection), an FDA-approved beta-amyloid positron emission tomography imaging agent, is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques.
“CMS appears to be challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment,” Daniel Skovronsky, MD, PhD, president and CEO of Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly, said in a press release. “Restricting coverage could hinder a timely and accurate diagnosis, which is in conflict with the advice of Alzheimer’s disease experts and with the administration’s National Alzheimer’s Project Act.”
The CMS decision said that “evidence is insufficient to conclude that the use of positron emission tomography amyloid-beta imaging improves health outcomes for Medicare beneficiaries with dementia or neurodegenerative disease.”