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Medicare Coverage Policy For Alzheimer's Drugs ‘Negates’ Value Of Accelerated Approval, Lilly Says

 
• By Cathy Kelly

Lilly downplays expectations for an US FDA accelerated approval of donanemab, given expectations that Medicare will persist in its plan to withhold coverage for Alzheimer's drugs outside of clinical trials. Policy experts are divided on whether the decision sets a precedent for future accelerated approvals.

Medicare Will Effectively Deny Access For donanemab Despite FDA Accelerated Approval, Lilly Believes • Source: Alamy

The Centers for Medicare and Medicaid Services’ recently-proposed national coverage determination restricting reimbursement for amyloid-directed monoclonal antibody drugs for Alzheimer’s disease to use in clinical trials undermines the commercial value of an accelerated approval in the class, according to Eli Lilly and Company.

Lilly no longer believes an accelerated approval from the US Food and Drug Administration for its Alzheimer’s drug candidate donanemab will achieve much in terms of patient access, chief scientific...

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The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

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ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

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• By Sue Sutter

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