CMS Begins Review of Aduhelm

The Centers for Medicare & Medicaid Services (CMS) has announced it is beginning a National Coverage Determination (NCD) analysis to determine whether Medicare will have a national policy for Aduhelm (aducanumab-avwa), Biogen's treatment for Alzheimer's disease that received FDA approval on June 7.

Currently, coverage determinations for Aduhelm are being made at the local level by individual plans. Some Blue Cross Blue Shield plans have already announced they won't cover Aduhelm because of there is insufficient evidence of clinical benefit and, therefore, not applicable for consideration of medical necessity. Other Blues plans have put Aduhelm on the list of therapies and procedures requiring prior authorization.

CMS will conduct the review through a process that includes an assessment of the clinical evidence, as well as public comments. The analysis aims to determine whether the evidence meets the Medicare law’s requirements that items or services be “reasonable and necessary for the diagnosis or treatment of illness or injury.”

So far, the agency has met with the Alzheimer’s Association, Biogen, Duke University, Margolis Center for Health Policy, and Johns Hopkins University. Two public stakeholder calls have been scheduled for July 22 and July 27.

Following the analysis, CMS will post a proposed national coverage determination, which will be open to a 30-day public comment period. After reviewing all comments received on a proposed determination, CMS will announce its final decision for a national policy.