"Until CMS announces the registry design and details, it is difficult to understand how a registry will impact patient access to Leqembi," Eisai said in a statement. Historically, such programs have limited access to patients in underserved communities, the company added.
"We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS' promise of broad coverage to all Medicare beneficiaries," a Lilly spokesman said in a statement. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs.
To receive Medicare coverage, people will need to be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer's and have a qualified physician participating in a registry.
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