Biogen's Aduhelm: A Cautionary Tale in Alzheimer's Treatment and Pricing

By: Jason Peterson, RPh, Senior Manager of Formulary Development at Nuwae 

Biogen, in partnership with Eisai, initially placed a strong emphasis on Aduhelm's development, envisioning it as a breakthrough and blockbuster seller in Alzheimer's treatment. However, as they encountered significant clinical and commercial obstacles, the focus shifted. The amended partnership with Eisai led to the emergence of Leqembi, another promising Alzheimer's drug, which received FDA approval based on its potential to slow cognitive decline. Biogen's recent decision to halt Aduhelm comes as a culmination of a series of controversies and challenges that have plagued the drug since its inception.  

FDA Controversy  

The FDA's advisory committee, typically heeded by the agency, unanimously advised against Aduhelm's initial approval. The FDA's subsequent decision to grant accelerated approval—bypassing the committee's recommendation—sparked intense debate and scrutiny. This decision was so contentious that it triggered a congressional investigation, uncovering what was described as "irregularities" and "lapses in protocol" in the FDA's process. Among the most alarming findings was an unusually close collaboration between the FDA and Biogen, raising questions about the integrity of the approval process and undermining public trust. 

Cost & Clinical Trial Concerns  

Initially priced at an exorbitant $56,000 per year, Aduhelm’s cost alone was a significant barrier, even before the price was cut to $28,000 annually—a figure still daunting for many. In addition to high cost, there was skepticism surrounding the drug’s safety and efficacy. Physicians have long been split over whether clinical trial data proves the monoclonal antibody actually slows cognitive decline. The lack of clear clinical benefit meant that many payers, including Medicare, restricted coverage, leaving patients in a limbo that required them to participate in clinical trials to access the treatment. 

From Aduhelm to Leqembi: A Strategic Shift 

While some experts argue that Aduhelm's approval was a misstep, it's undeniable that Biogen's experience has been a rich source of insights. These insights were pivotal in the development and approval of Leqembi, a drug similar to Aduhelm but with a different mechanism for reducing amyloid-beta plaques, the plaques in Alzheimer’s patients that block cell-to-cell signaling in the brain. Unlike its predecessor, Leqembi received traditional approval from the FDA, with clinical trials demonstrating a tangible slowdown in cognitive decline—a win for both Biogen and patients, with coverage extended by payers. 

The Future of Alzheimer's Treatment 

Although Aduhelm's journey may be seen as a commercial failure, its groundbreaking approval has undoubtedly set the stage for future Alzheimer's research. Biogen's strategic decision to transition resources from Aduhelm to Leqembi and other Alzheimer's treatments reflects a commitment to learning from the past and investing in the future. The hope is that these efforts will yield significant benefits for the millions of Americans battling Alzheimer's, proving that even in the face of setbacks, innovation in healthcare is a continuous and evolving path.