(C) Common Dreams This story was originally published by Common Dreams and is unaltered. . . . . . . . . . . Medicare Officially Limits Coverage of Aduhelm to Patients in Clinical Trials [1] ['Pam Belluck', 'More About Pam Belluck'] Date: 2022-04-07 The trials will still need to comply with a Medicare requirement to recruit a racially and ethnically diverse group of participants, contrasting with the previous trials of Aduhelm, in which most participants were white. In the trials, “the manufacturers will have to come to us with how are they going to include all patients that represent the Medicare population, and how are they going to ensure that all of these patients are getting appropriate medical treatment and monitoring of their treatment while they’re in each of these studies,” Tamara Syrek Jensen, the director of coverage and analysis for the Medicare agency’s Center for Clinical Standards and Quality, said in an interview. The F.D.A. has also required Biogen to conduct another clinical trial to determine if the drug provided any evidence of benefit, but it said that in the years it will take for that trial to be completed, Aduhelm would be available to patients. Under Thursday’s decision, Medicare would cover the costs for participants in Biogen’s trial. In a statement after the Medicare announcement, the F.D.A. said, “At the end of the day, both agencies have a shared goal of ensuring that safe and effective medical products are available for Americans.” Medicare’s coverage evaluation team makes decisions without considering the cost of a drug, but the Aduhelm decision could ease some concerns about how covering the drug might affect the pocketbooks of the country’s millions of Medicare beneficiaries. [END] --- [1] Url: https://www.nytimes.com/2022/04/07/health/aduhelm-medicare-alzheimers.html Published and (C) by Common Dreams Content appears here under this condition or license: Creative Commons CC BY-NC-ND 3.0.. via Magical.Fish Gopher News Feeds: gopher://magical.fish/1/feeds/news/commondreams/