The Centers for Medicare and Medicaid Services should require registries maintained by outside organizations that are tracking patients taking Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi to include all “critical data” that could shed light on safety and outcomes and, importantly, ensure that at least CMS has access to the data, health care providers, patients, physician groups, researchers and policy experts are urging the agency.
Key Takeaways
Two groups of researchers and physicians are advocating that:
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CMS should require private organizations hosting registries for Leqembi to allow outside researchers access to the data as a condition of coverage
In two recent letters to CMS and the Department of Health and Human Services, the experts call for transparency and consistency in
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