The trial was an observational study aimed at collecting real-world data on the Alzheimer’s treatment.
Biogen is terminating its observational, post-marketing trial of Aduhlem (aducanumab-avwa) because the company expects limited usage of the Alzheimer’s disease medication.
“As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice, making the study not feasible for enrollment,” Biogen posted in a June 21 update on Clinicaltrials.gov.
A spokesperson for Biogen said the pharmaceutical manufacturer did not want to provide additional comments or information on the decision.
In early April, CMS confirmed that Medicare will only cover Aduhelm for patients in specific clinical trials. In its final Medicare national coverage determination (NCD), CMS said FDA-approved monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized, controlled trial conducted under an investigational new drug application.
The trial being cancelled is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa compared with standard of care. Participants would have followed up to five years after enrollment.
Biogen is, however, currently recruiting patients for its confirmatory phase 4 trial. The ENVISION study is a randomized, placebo controlled trial that aims to verify the benefit of Aduhelm in patients with early Alzheimer’s disease. It is a requirement based on FDA’s accelerated approval of Aduhelm. The primary endpoint for the trial will be measured by the Clinical Dementia Rating–Sum of Boxes (CDR-SB) at 18 months. The trial will also include a planned long-term extension to collect treatment data for up to 48 months.
Additionally, because of the CMS decision, Biogen said at the time that it would “substantially eliminate its commercial infrastructure supporting Aduhelm, retaining minimal resources to manage patient access programs, including a continued free drug program for patients currently on treatment in the United States.”
In addition, Biogen CEO Michel Vounatsos agreed to step down.
In early May, UnitedHealthcare said in an updated Medical Drug Benefit Policy that patients taking Aduhelm must be in an approved clinical trial. The drug is “unproven and not medically necessary for the treatment of Alzheimer’s disease due to insufficient evidence of efficacy.”