Medicare Officially Restricts Coverage of Biogen's Aduhelm

John Tlumacki/The Boston Globe via Getty

Shares of Biogen are falling in post-market trading after the U.S. government officially announced it will limit coverage of the company’s controversial Alzheimer’s drug Aduhelm to patients in clinical trials.

The move by Medicare officials will severely limit the availability of the drug to Alzheimer’s patients, many of whom receive coverage through the federal insurance program. It is estimated that there are about 1.5 million people in the United States who have been diagnosed with mild Alzheimer’s-related cognitive decline, which is the indication for which it received its controversial approval from the U.S. Food and Drug Administration.

For months, the government had signaled its intentions to limit coverage of Aduhelm (aducanumab) to clinical patients. It was the first Alzheimer’s drug approved in the United States in nearly 20 years and was greenlit under the FDA’s accelerated approval program. In January, the CMS first issued its draft notice about the limitations. In its response, Biogen had hoped to mitigate the draft proposal with its own three-point approach to use real-world evidence in order to complement any perceived shortcomings in clinical data. The Bay State-based company pressed its case, noting that any decision to limit the FDA-approved drug could negatively impact current patients, as well as the development of future therapies for the devastating disease.

According to the New York Times, Chiquita Brooks-LaSure, the administrator of the Centers for Medicare and Medicaid Services (CMS) said today’s decision was “was intended to protect patients while gathering data to indicate whether Aduhelm… could actually help them by slowing the pace of their cognitive decline.”

Pointing to the majority of the approximately 10,000 comments CMS received on its website, Brooks-LaSure said most were in favor of “really limiting coverage of Aduhelm to a really controlled space where we could continue to evaluate its appropriateness for the Medicare population.”.

Biogen has not issued a formal response to the CMS ruling. BioSpace has reached out to the company seeking comment about the decision, as well as the future of Aduhelm in the United States. In its report, Bloomberg cited some analysts who suggested the CMS limitations could not only spell the end for Aduhelm but also trigger additional cost-cutting measures at Biogen. Last month, the company began to lay off employees. Biogen indicated that it was cutting about 10% of its staff. Last year, the company announced a $500 million cost-savings program but it was not believed that the savings will be entirely driven by headcount.

Some early reports around the layoffs indicated that many of the commercial team associated with its Alzheimer’s drug had been let go.

Since its June 2021 approval, Biogen has struggled to gain commercial ground for Aduhelm. The drug has been hampered over concerns with efficacy, as well as safety. This year, Biogen was hammered by reports of additional deaths of patients who took Aduhelm. At least four elderly adults have died after taking the medication, according to data in the U.S. Food and Drug Administration’s Adverse Events Reporting System (FAERS). It’s important to note that the elderly patients had other complications beyond Alzheimer’s that could have been the cause of death. During the clinical development of Aduhelm, researchers observed cases of amyloid-related imaging abnormalities (ARIA-E), also known as cerebral edema. The drug’s warning label points to possibilities of ARIA-E. Regardless, the specter of safety concerns has cast a long shadow over the first Alzheimer’s drug to be approved in the U.S. in nearly two decades.