Biogen Ends Aduhelm Study Due to Medicare Restrictions

Biogen has ended its observational ICARE AD real-world data (RWD) trial for Aduhelm, another in a long series of setbacks for the drug. The move was caused in part by the Centers for Medicaid and Medicare Services’ (CMS) decision to only cover the drug for patients in clinical trials. The ICARE AD trial was aiming for 6,000 participants but only managed to recruit 29 patients since its launch in November.

According to Angus Liu, “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.”

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(Source: Fierce Pharma, June 23^rd, 2022)