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Lilly’s ‘High Quality’ Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says

 
• By Cathy Kelly

As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.

Demonstrating The Value Of The Drug To Its Leading Prospective Payer • Source: Shutterstock

The Centers for Medicare and Medicaid Services should reopen its Medicare national coverage determination for Eli Lilly and Company’s Alzheimer’s drug donanemab based on the company’s clinical trial and real-world data, Lilly researchers conclude in a paper published in the journal Alzheimer’s & Dementia earlier this month.

Key Takeaways

  • Lilly is marshalling its data to demonstrate that patient registry requirements should not be a condition of Medicare coverage for donanemab.

  • Approval of donanemab would give CMS additional information on the clinical benefits and risks of such treatments

Issued in April 2022, the Medicare NCD limits reimbursement of anti-amyloid monoclonal antibody treatments with traditional US Food and Drug Administration approval to patients enrolled in a registry

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