In early July, CMS said it would start covering the drug for Medicare patients outside of clinical trials. Physicians who wish to prescribe Leqembi must submit data to an agency-run patient registry to collect evidence on the drug’s real-world efficacy. CMS has committed to sharing that data with researchers.
“However, we are very concerned that Leqembi registries developed by medical societies, medical centers, nonprofit organizations or other non-governmental entities may limit access to their respective population-level data, potentially making it difficult for CMS and other researchers to conduct independent analysis of the data,” the experts wrote in a July 27 letter to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure.
As a condition of coverage, CMS should require that data submitted to all registries must be accessible for independent statistical analysis, the researchers said. Additionally, all registries, whether government-funded or privately run, should collect a standard set of baseline information, they added.
View the full letter here.
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