Accelerated approval not accelerated access: Clinical trials required for coverage of Alzheimer's treatments
By Xcenda
With the Alzheimer’s disease drug market expected to increase over the next few years, a dynamic interplay between market and policy has emerged.
In January, CMS proposed a National Coverage Decision (NCD) through Coverage with Evidence Development (CED) for an entire class of Alzheimer’s treatments – including future treatments. Accordingly, patient participation in a qualifying randomized clinical trial would be the only pathway to coverage for monoclonal antibodies directed against amyloid plaque for the treatment of Alzheimer’s.
Download our new issue brief that explains this proposed coverage decision, next steps, potential access challenges, and how this may impact your next launch.
In January, CMS proposed a National Coverage Decision (NCD) through Coverage with Evidence Development (CED) for an entire class of Alzheimer’s treatments – including future treatments. Accordingly, patient participation in a qualifying randomized clinical trial would be the only pathway to coverage for monoclonal antibodies directed against amyloid plaque for the treatment of Alzheimer’s.
Download our new issue brief that explains this proposed coverage decision, next steps, potential access challenges, and how this may impact your next launch.
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