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Lilly Phase III Alzheimer’s Data Will Set Stage For Unrestricted Medicare Coverage Request

 
• By Cathy Kelly

Donanemab results due next year have a good chance of persuading CMS to offer unrestricted coverage, Lilly argues, even though the drug might just have accelerated approval at that point. ‘We believe that having two positive pivotal trials should meet that high level of evidence.’

• Source: Alamy

Eli Lilly and Company is hoping that release of Phase III data on its Alzheimer’s drug candidate donanemab in about a year will persuade the Centers for Medicare and Medicaid Services to quickly agree to unrestricted Medicare coverage for the drug, company officials said during the company’s earnings call 28 April.

Under a national coverage determination released in early April, Medicare coverage for all amyloid-directed monoclonal antibodies for Alzheimer’s would be conditioned on further evidence collection, either from a randomized clinical trial, for accelerated approvals, or based on data collection through routine clinical practice or patient registries for drugs with traditional approvals

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