FDA’s accelerated approval of aducanumab for the treatment of Alzheimer’s disease (AD) has added urgency to the discourse around evidence generation for this and other AD monoclonal antibodies (mAbs), treatment costs, and patient access to treatment. As more information is expected to flow from aducanumab’s phase 4 trial and pivotal trials of other anti-amyloid mAbs, important evidentiary gaps and uncertainties remain. Recently, CMS announced its proposed decision to cover the class of AD anti-amyloid mAbs for the treatment of AD under a coverage with evidence development (CED) framework, only in randomized controlled trials.
The Duke-Margolis Center for Health Policy convened a meeting with the FDA to identify the issues associated with AD mAb treatments that are important to the payer community and continues to work with different stakeholders to define key evidentiary gaps and opportunities to generate data and improve the evidence base on these treatments to inform future coverage decisions. The Center is also developing issue briefs and comment letters to CMS that address these pressing issues.
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