Early-Stage Alzheimer's Disease Treatment

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.

Related Events, Publication, and Materials

CMS Comment Letters

CMS Comment Letter, August 2021

CMS Comment Letter on Proposed Coverage Decision, February 2022

Alzheimer’s Disease Monoclonal Antibody Treatments: Evidence and Payment Updates

Medicare Coverage of Monoclonal Antibody Treatments for Alzheimer’s Disease: Key Issues from the CMS Proposed Coverage Decision - January 24, 2022

Understanding Payer Evidentiary Needs for Alzheimer’s Disease Monoclonal Antibody Treatments
July 14, 2021

Roundtable Objective:
Important progress in clinical research and innovative Alzheimer’s Disease monoclonal antibody (AD mAb) drug development has been made over the last decade, and potentially transformative treatments may be on the horizon. However, the opportunity to treat patients with this new class of therapies will be accompanied by questions related to patient access, treatment costs, and long-term data collection on patient outcomes.

This multistakeholder roundtable explored the issues associated with the use of these AD mAb treatments that are important to the payer communities. Specifically, sessions focused on the broader therapeutic class landscape, how payer groups envision continuing evidence development efforts in a postmarket setting, and ideas for working together to track utilization and patient outcomes. This roundtable did not focus on the approval process or approval requirements for any mAb therapy.

July 14 Meeting Summary

July 14 Meeting Discussion Guide