Some Blues Plans Won’t Cover New Alzheimer’s Therapy Aduhelm

Some Blue Cross Blue Shield plans have announced they won't cover Aduhelm (aducanumab-avwa), Biogen's treatment for Alzheimer's disease that received FDA approval on June 7. Plans that have said "no" so far include:

• Blue Cross Blue Shield North Carolina,
• Independence Blue Cross,
• Blue Cross Blue Shield Michigan,
• Blue Cross Blue Shield Western New York, and
• Blue Cross Blue Shield of Kansas.

These plans have indicated Aduhelm is considered investigational due to insufficient evidence of clinical benefit and not applicable for consideration of medical necessity. As such, there is no coverage for investigational therapies.

Additional Blues plans, such as Highmark Blue Cross Blue Shield and Blue Cross Blue Shield Blue Care Network of Michigan, have put Aduhelm on its list of therapies and procedures requiring prior authorization, but they note this applies to standard commercial plans. Premera Blue Cross has added Aduhelm to its prior authorization list for Medicare Advantage Plus, Part B plans.

Last week, it was announced that Amber Specialty Pharmacy, a subsidiary of Hy-Vee Inc located in Omaha, Neb., will be dispensing Aduhelm. Amber Specialty Pharmacy is licensed in all 50 states, as well as Puerto Rico.

The controversy surrounding this therapy is related to both the clinical trial results and Biogen's pricing of the therapy. The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline, while the second trial did not meet the primary endpoint.

At the end of June, the Institute for Clinical and Economic Review (ICER) updated its analysis for the drug, stating the price range needed to reach standard cost-effectiveness thresholds is between $3,000 and $8,400 a year, compared with the annual price of $56,000 set by Biogen.