Medicare finalizes policy restricting Aduhelm coverage to clinical trial patients

Medicare will only cover Biogen’s Alzheimer’s therapy Aduhelm during clinical trials, the Centers for Medicare and Medicaid Services announced Thursday, finalizing a proposal from January.

Medicare beneficiaries participating in clinical trials overseen by CMS, the Food and Drug Administration or the National Institutes of Health are eligible for Aduhelm coverage under the new policy. A previous version limited reimbursement for the medicine to patients in CMS- or NIH-approved studies.

The limited Aduhelm coverage decision won’t automatically extend to new Alzheimer’s disease medications so long as they are subject to full FDA reviews rather than the accelerated process the regulator used to approve Biogen’s treatment, CMS said.

This is a developing story. Check back for updates.