Lilly Comments on Proposed Medicare Coverage for Class of Alzheimer’s Treatments

The CMS decision could undermine the promise of the entire drug class 

Anne White, President of Lilly Neuroscience, has provided public comment to the Centers for Medicare & Medicaid Services (CMS) to share Lilly’s perspective on the proposed National Coverage Decision (NCD) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. Read the full comment letter here.  

Lilly is proud of the data that we published for our investigative therapy, donanemab, in the New England Journal of Medicine and is excited for the data that are to come. But the potential benefits of any amyloid plaque-reducing therapy can only become reality if patients have timely and equitable access to both therapies and diagnostics.  

We fear the proposed NCD undermines the promise of an entire drug class, contributing to unnecessary suffering and irreversible decline for people living with A. It’s our duty to advocate for fair patient access based on clinical evidence to support patients, their caregivers and families. We are concerned that the proposed NCD will impede access to anti-amyloid therapies for several years as patients deal with an unrelenting progressive disease where severity will continue to advance. 

We urge CMS to revise the proposed NCD to provide automatic national coverage for on-label use of anti-amyloid treatments where confirmatory data demonstrate slowing of decline in cognition and function. Alternatively, CMS should issue NCDs on a drug-by-drug basis.  

After more than 30 years of dedicated research, we are on the brink of meaningful change for people living with Alzheimer’s disease. Lilly has multiple therapeutics and diagnostics for neurodegeneration in various stages of clinical development. Lilly’s neurodegeneration pipeline reflects innovation, investments, and collaborations aimed at the entire spectrum of Alzheimer’s disease.  

We’re strongly committed to additional data development for anti-amyloid treatments in new patient populations. If finalized, the proposed NCD will have a chilling effect on Alzheimer’s research. If CMS makes Alzheimer’s disease research investment unattractive, entities will shift investment to other diseases where these barriers do not exist. People with Alzheimer’s disease will be the ones to suffer while they continue to wait for a cure.  

Even in the face of scientific setbacks, Lilly has never wavered in its dedication to end this terrible disease. It’s a personal pursuit for many of us. We’ll continue to advocate for what is in the best interest of people living with Alzheimer’s disease and their caregivers and families.