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Updated: Aug 6, 2026
07:28
Full- versus Sub-Regional Quantification of Amyloid-Beta Load on Mouse Brain Sections
Published on: May 19, 2022
Further data to address the Alzheimer's coverage with evidence development questions
Malaz Boustani1, Eric G Klein2, Jennifer A Zimmer2
1Indiana University School of Medicine, Indianapolis, Indiana, USA.
Summary
Updated evidence on amyloid-targeting therapies for Alzheimer's disease shows continued benefits and manageable safety profiles. Reconsideration of Medicare coverage with evidence development is now scientifically justified.
Area of Science:
- Neurology
- Pharmacology
- Medical Policy
Background:
- Current Medicare coverage for Alzheimer's disease amyloid-targeting therapies is under a 2022 National Coverage Determination (NCD) with Coverage with Evidence Development (CED).
- A previous 2024 review addressed the CED questions, but the 2022 NCD remains in effect.
Purpose of the Study:
- To update the previous review by analyzing new extension and safety data for donanemab and lecanemab.
- To assess whether the new evidence addresses the existing CED questions and justifies reconsideration of the NCD.
Main Methods:
- Systematic review and synthesis of recently published extension data for donanemab and lecanemab.
- Analysis of new safety data, including identification of risk factors for amyloid-related imaging abnormalities (ARIA).
- Evaluation of modified dosing regimens for donanemab regarding ARIA risk.
Main Results:
- New evidence directly addresses the three Coverage with Evidence Development questions.
- Extension studies demonstrate sustained therapeutic benefits without new safety concerns.
- Baseline risk factors for ARIA were identified, and a slower donanemab titration schedule reduced ARIA-edema/effusion risk.
Conclusions:
- The recently gathered evidence scientifically justifies reconsideration of the class-based National Coverage Determination.
- Updated data support the continued benefit and safety of amyloid-targeting therapies for Alzheimer's disease.
Keywords:
Alzheimer diseaseCenters for Medicare and Medicaid ServicesDonanemabMedicareNational Coverage Determinationamyloid‐related imaging abnormalitiesamyloid‐targeting therapyanti‐amyloid monoclonal antibodycerebral edemacognitive and functional declinecoverage with evidence developmentdementiaearly symptomatic Alzheimer's diseasehealth outcomesmild cognitive impairment
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