Further data to address the Alzheimer's coverage with evidence development questions
Malaz Boustani, Eric G. Klein, Jennifer A. Zimmer, Hong Wang, Staci E. Engle, Adam Phipps, Maureen Japha, Traci Schilling, Ann Hartry,Abstract
INTRODUCTION
Medicare patients currently access amyloid‐targeting therapies for Alzheimer's disease through the class‐based National Coverage Determination (NCD) with coverage with evidence development (CED) established in 2022. Evidence addressing the stated CED questions was previously published in a 2024 review; however, the original 2022 NCD remains unchanged.
METHODS
Update the previously published review responding to the CED questions by summarizing recently published donanemab and lecanemab extension data and new safety‐related data.
RESULTS
New evidence addresses each of the three CED questions. Extension data show that the benefit of amyloid‐targeting therapy continues to accrue with no new safety signals observed. Safety analyses identified baseline risk factors for amyloid‐related imaging abnormalities (ARIA). Further, a more gradual donanemab titration regimen decreased risk of ARIA‐edema/effusions.
DISCUSSION
With CED questions addressed, reconsideration of the class‐based NCD is scientifically justified.
Clinical Trial Registration : NCT04437511, NCT05738486, NCT03887455