Biogen, citing insurance challenges, shutters one of its Aduhelm studies
Following a ruling by the US federal insurance program, Medicare, a company claims it was forced to end an observational trial of the Alzheimer's drug Aduhelm.
Biogen stated that a recent Medicare coverage decision forced it to abandon the drug trial after only 29 participants were enrolled.
Following the ruling, the company stated that it made the decision to halt the large study evaluating its marketed treatment.
Years of information
The ICARE AD study hoped to collect years of data on patients who had been prescribed Biogen's drug, which is sold under the brand name.
The study, along with two other clinical trials - one of which requires Aduhelm to remain on the market - was designed to generate more evidence of the drug's effects following its controversial approval last year.
With ICARE AD, the company hoped to enroll up to 6,000 patients across approximately 200 centers in the United States.
According to a federal clinical trials database, the study had only 29 participants eight months after it officially began. On the study's database entry, only 22 trial sites were listed.
Biogen attributes the low number of participants to a policy decision by Medicare, which was expected to cover the majority of patients eligible for Aduhelm.
Clinical trials under strict control
In April, Medicare confirmed that it would not pay for Aduhelm or similar drugs unless patients were enrolled in randomized, controlled clinical trials rather than observational trials like ICARE.
Early sales figures indicated that the drug had only been prescribed to a small percentage of the millions of Alzheimer's patients in the United States, making enrollment in ICARE AD much more difficult, ultimately leading to Biogen terminating the study.
Participants in the study were supposed to be followed for five years, with regular visits every six to twelve months to assess changes in cognition and function.
"We cancelled ICARE-AD because, given the national policy for coverage, there will be limited ADUHELM prescription and usage in ordinary clinical practice, and thus Biogen will not be able to further pursue the trial," a Biogen spokeswoman said in a statement.