Medicare will only cover Biogen's Alzheimer's therapy Aduhelm during clinical trials, the Centers for Medicare and Medicaid Services announced Thursday, finalizing a proposal from January.
The announcement paves the way for CMS to reduce Medicare Part B premiums. Health and Human Services Secretary Xavier Becerra said last month that CMS was waiting on a final coverage decision for Aduhelm to fully assess its impact on Part B premiums for 2022, which increased 15% from last year, in part because of projected spending on the drug.
Medicare beneficiaries participating in clinical trials overseen by CMS, the Food and Drug Administration or the National Institutes of Health are eligible for Aduhelm coverage under the new policy. In its final decision, CMS removed exclusion criteria specified in the proposed decision because it would have left out some populations, including people with Down syndrome.
"There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare," CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality Dr. Lee Fleisher said in a news release.
The coverage decision applies to all monoclonal antibody treatments for Alzheimer's disease, of which Aduhelm—also known as aducanumab—is the first to obtain FDA approval.
This limited coverage policy won't automatically extend to new Alzheimer's disease medications so long as they are subject to full FDA reviews rather than the accelerated process the regulator used to approve Biogen's treatment.
The Food and Drug Administration approved Aduhelm last June despite uncertainty about its efficacy and some concerns over its safety. The medicine may cause headaches, falls or even bleeding in the brain, according to CMS.
CMS received more than 10,000 comments on its draft Medicare coverage plan from January. The Alzheimer's Association and other advocacy organizations argued the proposal would cut off access to Aduhelm, especially for underserved populations less likely to participate in clinical trials.
But others viewed CMS's decision as appropriate, given the limited evidence available on the drug.
"We commend the administration's decision today to limit Aduhelm coverage to Medicare beneficiaries participating in clinical trials. The Centers for Medicare and Medicaid Services has shown that its coverage decisions are guided by science and quality care for beneficiaries," Alliance of Community Health Plans President and CEO Ceci Connolly said in a news release. CMS should reevaluate Part B premiums in light of the coverage decision, she said.
At its original $56,000 annual price, Aduhelm would have cost Medicare $29 billion a year. according to Kaiser Family Foundation analysis. CMS does not factor prices into national coverage determinations.
Critics contend the medication is still overvalued at its lower price, and some health systems won't prescribe it due to doubts about its effectiveness.
The nation's 25 largest insurers do not consider Aduhelm to be "medically necessary," according to a Bloomberg News report. Medicaid must cover Aduhelm but can states can choose to subject it to prior authorization.