Biogen’s Alzheimer’s Drug Could Face Efficacy Checkpoints Amid Pricing Concerns

Biogen’s FDA-approved Alzheimer’s drug, aducanumab, faces uncertainty amid efficacy and pricing concerns. Now, experts are pushing the Centers for Medicare & Medicaid to begin a Medicare National Coverage Determination (NCD) for the drug, which would include an efficacy analysis. While the drug has been shown to decrease amyloid plaques in clinical trials, its effects in improving cognitive function remain dubious.

“NCDs are the most powerful coverage tool that Medicare has and have generally been reserved for Medicare services that are costly or may be subject to variable local coverage decisions, or where there is a divide in the scientific community regarding efficacy among Medicare beneficiaries.CMS should preemptively generate an internal request for an NCD regarding aducanumab to best protect Medicare beneficiaries from receiving a therapy where the risks likely outweigh the benefits.”  Read more here.

(Source: Sean Dickson, Amy Killelea, Richard Frank; Health Affairs; 6/7/21)