CMS Says It Will Limit Biogen’s AD Drug to Patients in Clinical Trials

CMS Tuesday announced it would only cover Alzheimer disease (AD) drugs like Biogen’s biologic for Medicare patients enrolled in clinical trials.

Biogen’s aducanumab (Aduhelm) was approved in June 2021 by the FDA. However, the decision was fraught with controversy over whether the value and benefits of the monoclonal antibody was justified by its price and risk of adverse events, including possible brain bleeding. It is the first new therapy for AD in nearly 2 decades.

In the National Coverage Determination (NCD) decision memo released Tuesday, CMS said it will gather public comment for 30 days and expects to make a final decision by April 11. Besides aducanumab, the NCD would also cover other similar monoclonal antibodies approved by the FDA through coverage with evidence development (CED)–meaning enrollment in qualifying clinical trials—that work the same way, by targeting the buildup of amyloid beta plaques in the brain.

“Alzheimer’s disease is a devastating illness that has touched the lives of millions of American families. Throughout this National Coverage Determination process, CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients,” said CMS Administrator Chiquita Brooks-LaSure in a statement. “CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders. Before finalizing this proposal, we will have more opportunities to hear from people with Medicare living with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia, their family members and caregivers, as well as many other stakeholders, including patient advocacy groups, medical experts, states, payers, and industry professionals.”

If the proposed NCD is finalized, CMS will review each submitted clinical trial to determine whether it meets its criteria.

The price of the infused biologic was initially set at $56,000 annually, but Biogen cut the price by 50% last month amid slow uptake by insurers and health systems. Given the price cut, HHS said Monday it would ask CMS to reassess Medicare Part B premiums.