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How donanemab data address the coverage with evidence development questions
Eric G Klein1, Krista Schroeder2, Alette M Wessels2
1Global Medical Affairs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.
Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|February 7, 2024
Summary
Donanemab significantly slowed cognitive decline in early Alzheimer's disease (AD) patients. The drug demonstrated a manageable safety profile, supporting reconsideration of coverage for AD treatments.
Area of Science:
- Neurology
- Pharmacology
- Clinical Trials
Background:
- Alzheimer's disease (AD) poses a significant challenge, necessitating effective treatments.
- The Centers for Medicare & Medicaid Services (CMS) established Coverage with Evidence Development (CED) criteria for amyloid-targeting monoclonal antibodies in AD.
- Donanemab is an investigational monoclonal antibody targeting amyloid plaques.
Approach:
- This review analyzes data from the TRAILBLAZER-ALZ trials for donanemab.
- Evidence from supporting literature and real-world data is integrated.
- The analysis directly addresses the three CED questions set by CMS.
Key Points:
- Donanemab demonstrated statistically significant slowing of cognitive and functional decline in early symptomatic AD patients with confirmed amyloid positivity.
- The treatment lowered the risk of disease progression.
- Key safety risks, primarily amyloid-related imaging abnormalities (ARIA), occurred mainly within the first six months and subsequently declined with monitoring.
Conclusions:
- Donanemab shows meaningful improvement in health outcomes for early symptomatic AD, with a manageable safety profile.
- Trial participant demographics, comorbidities, and co-medications align with the broader Medicare population.
- The presented evidence supports a reconsideration of the current National Coverage Determination (NCD) for donanemab.
Keywords:
Alzheimer's diseaseCenters for Medicare and Medicaid ServicesCoverage with Evidence DevelopmentMedicareNational Coverage Determinationamyloid‐related imaging abnormalitiesamyloid‐targeting therapyanti‐amyloid monoclonal antibodybrain hemorrhagecerebral edemacognitive and functional declinedementiadonanemabearly symptomatic Alzheimer's diseasehealth outcomesmild cognitive impairmenttauMore Related Videos
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