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CMS Released Final Decision on Aduhelm

Contributed by Joshua Grill, PhD:

The Centers for Medicaid and Medicare Services (CMS) recently released their final decision related to coverage for the monoclonal antibody against beta amyloid, aducanumab (Aduhelm®). The decision was expected by many and includes only a few changes from the preliminary decision announced January 11. The decision remains that CMS will pay for aducanumab under a coverage with evidence determination (CED).

This means that the drug will only be covered when a person with Mild Cognitive Impairment or mild dementia is enrolled in a randomized controlled trial. Such trials will need to be approved by CMS and could be funded by NIH or other sources, including the company that makes aducanumab, Biogen. As evidence of what a major issue this decision was, CMS received more than 10,000 comments during the public comment period. According to CMS, the majority of comments supported the preliminary CED decision or requested CMS not cover aducunamab.

One notable change from the preliminary CED decision is the inclusion of people with Down syndrome in the CED. Another is that the decision was adjusted to state future monoclonal antibodies against the amyloid protein could achieve full coverage, if they demonstrate clinical efficacy in registration clinical trials to achieve full FDA approval (aducanumab has mixed clinical efficacy data and was only accelerated approval by the FDA).

What comes next? Time will tell what trials of aducanumab will be performed and covered by the CED. In the meantime, important Phase 3 trials of other monoclonal antibodies in people with Mild Cognitive Impairment and mild dementia are ongoing. Three major clinical trials are also testing monoclonal antibodies as potential disease-delaying or prevention therapies. This includes the AHEAD Study happening at UCI MIND.