For Biogen’s ill-fated Alzheimer’s disease drug Aduhelm, a narrow Medicare reimbursement policy is taking a toll beyond sales and on the company’s clinical development plan.
Biogen has pulled the plug on the observational ICARE AD trial, which was meant to collect real-world data on Aduhelm’s use in the U.S., according to an update posted Tuesday on ClinicalTrials.gov. A Biogen spokesperson confirmed the status to Fierce Pharma.
The termination comes as a result of the national coverage policy, Biogen said on the clinical trial registry. “[I]t is expected there will be limited [Aduhelm] prescription and usage in routine clinical practice, making the study not feasible for enrollment.”
Biogen had originally planned to enroll 6,000 participants for the real-world study. But after seven months since it kicked off mid-November, only 29 patients have joined, ClinicalTrials.gov shows.
For those who began treatment on or before April 7, Biogen has established a continuity of care plan to offer Aduhelm at no cost for the duration of their treatment, a Biogen spokesperson told Fierce Pharma.
Back in April, the Centers for Medicaid & Medicare Services stuck to a restrictive policy for Aduhelm, confining the drug’s coverage to only those participating in a randomized, controlled clinical trial. The decision effectively means the end to Aduhelm’s commercial outlook given the limited number of patients for any clinical trial. The drug sold only $2.8 million in the first quarter.
Biogen’s chance for potential broader coverage now hinges on the phase 4 ENVISION trial, which is designed as the confirmatory study for Aduhelm’s accelerated approval. But it will take years before Biogen could have a readout.
In anticipation of a negative Medicare policy, Biogen in January slightly boosted ENVISION’s size to a target of 1,512 participants. That study officially started June 2 and has a primary completion date at the end of 2025.
The Biogen spokesperson confirmed to Fierce Pharma that site activation and patient scheduling for screening in ENVISION has begun. But apparently no patient has received the drug—the spokesperson said Biogen will provide updates when patient dosing is initiated in the future.
Besides the now-terminated ICARE AD study and the ongoing ENVISION trial, Biogen has a phase 3b study called EMBARK testing the longer-term effects of Aduhelm by re-dosing patients from past Aduhelm studies. The trial design means it’s not recruiting new patients.
Given the destructive Medicare policy, Biogen last month said it will cease Aduhelm commercial activities and chop the sales team as part of a deepened $1 billion cost-saving plan. That leaves the company with “minimal resources” managing existing patient access programs.
Along with the rightsizing, Biogen is also bidding farewell to CEO Michel Vounatsos, a staunch supporter of Aduhelm despite all the controversies around its efficacy and safety.
Meanwhile, Biogen’s attention has shifted to its second anti-amyloid beta antibody lecanemab, for which its partner Eisai is leading the charge. Eisai finished a rolling submission of lecanemab to the FDA last month to seek an accelerated approval based on biomarker data. The drug’s confirmatory Clarity AD trial, which will show key results on whether it could slow clinical symptoms of Alzheimer’s, is expected to read out this fall.