Rep. Anna Eshoo of California, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan, D-Calif., raised concerns in a letter to CMS last month that patients could struggle to find a doctor participating in the system.
Tomas Philipson, who advised the FDA commissioner and CMS administrator during the second Bush administration, said the registry is an unnecessary hurdle and Medicare should drop it, but he doesn't believe the requirement will create an insurmountable barrier to patients accessing Leqembi. Sen. Bernie Sanders, I-Vt., chair of the Senate Health Committee, has called Leqembi's price "unconscionable" and in alast month asked Health and Human Services Secretary Xavier Becerra to take action to reduce the cost.
Philipson said delaying Medicare coverage of Leqembi would result in increased health-care spending as people with mild Alzheimer's disease, which can be managed at home, progress to more serious disease that requires expensive nursing home care. And representatives from the National Center for Health Research and Doctors for America, also nonprofits, told the panel that Eisai's clinical trial did not include enough Black patients, who are at higher risk for Alzheimer's disease.
The FDA's advisory committee declined to endorse Aduhelm because the data did not support a clinical benefit to patients. Three advisors resigned after the agency's decision to approve the treatment anyway.
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