Insurers applaud CMS' proposal for Medicare to only cover Aduhelm for seniors in clinical trials

Insurer groups applauded the Biden administration’s decision to narrowly cover Alzheimer’s disease drug Aduhelm, as the industry has had concerns over the effectiveness of the controversial treatment.

The Centers for Medicare & Medicaid Services (CMS) announced Tuesday a proposal that Medicare will cover Aduhelm but only for patients in qualifying clinical trials. Several insurance industry groups applauded the measure after some major insurers have shown reticence in covering the pricey treatment.

“We agree with CMS that there is a need to obtain more clinical data on efficacy, which will be essential to ensuring these new medications deliver real value to patients before broadening access,” said Matt Eyles, president and CEO of America's Health Insurance Plans, the top insurance lobbying group.

The Blue Cross Blue Shield Association also lauded the decision.

“Collecting and analyzing more data on Aduhelm will provide much-needed insights into the drug’s safety and effectiveness,” said Adam Myers, M.D., senior vice president and chief clinical transformation officer for the association.

The Food and Drug Administration granted accelerated approval in June 2021 to Biogen’s Aduhelm to target beta amyloid plaques in the brain, despite objections from agency advisers over its effectiveness. But there has been a major blowback from insurers over whether to cover the drug, especially after Biogen decided to price it at $56,000 for a course of treatment.

One expert says Medicare’s reluctance to fully cover Aduhelm may not have lasting ramifications on the insurance industry as payers are already skeptical of the drug.

“Insurers follow CMS for guidelines on what to cover, and the reputation of this drug is everything but positive, with close to zero proven clinical benefit. My guess is that this will have no impact on insurer coverage,” said Michael Abrams, managing partner of global healthcare consultant firm Numerof & Associates, in a statement to Fierce Healthcare.

A survey conducted by Bloomberg News of more than two dozen major health insurers found they did not believe that the drug was medically necessary. Insurers such as Excellus BlueCross Blue Shield won’t cover the drug, and Highmark only will cover it with prior authorization.

Major hospital systems like Cleveland Clinic and Mount Sinai announced last summer they are not going to prescribe Aduhelm.

Biogen decided back in December to halve the price of Aduhelm after the backlash. The decision prompted Department of Health and Human Services Secretary Xavier Becerra to ask CMS to reevaluate a 15% spike in premiums for Part B prompted in anticipation of Medicare’s coverage decision.

The drugmaker slammed CMS’ proposal to only cover the drug for patients in a qualifying clinical trial, saying it will “significantly limit patient access to an FDA-approved treatment.”

The agency is holding a 30-day comment period on the proposed national coverage with evidence determination. CMS will issue a final determination in April.