With accelerated approval granted and a supplemental filing for full approval in the FDA's hands, Eisai set a price it says is below the “societal value” its Alzheimer’s drug provides as it prepares to seek Medicare coverage. Labeling notably comes with no black box warning or safety restrictions despite various concerns.

Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.

One patient treated with Aduhelm died who was diagnosed with cerebral edema thought to be ARIA-E, a known risk, Biogen confirmed.