Commonwealth Fund July 14, 2022
Toplines
Controversy surrounding Aduhelm’s extremely high cost, along with questions over its clinical benefit and health risks to patients, has placed the accelerated approval program under scrutiny
As state and federal governments continue to struggle with the growing costs of accelerated-approval drugs, Congress is likely to face continued calls for more significant reforms
In June 2021, the Food and Drug Administration (FDA) approved the Alzheimer’s drug Aduhelm through the agency’s Accelerated Approval Program. This pathway allows for earlier approval of drugs that offer a meaningful benefit over existing therapies and treat serious conditions that have an unmet medical need. Controversy surrounding Aduhelm’s extremely high cost, along with questions over its clinical benefit and health risks to patients, has placed the...