Medicare will require data on patient use for approved Alzheimer’s drugs

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(Reuters) -The U.S. Medicare health plan said on Thursday it would limit reimbursement for Eisai Co (OTC:ESAIY) Ltd and Biogen Inc (NASDAQ:BIIB)’s Alzheimer’s drug Leqembi to patients whose doctors participate in a health agency database should the drug win full approval, a move advocates say will hinder its use.

Leqembi received accelerated approval from the FDA in January, based on limited evidence suggesting it would slow cognitive decline in early Alzheimer’s patients. A panel of FDA advisers will discuss whether Leqembi should receive traditional approval next week, and a decision could come by early July.

Medicare, the government health plan for Americans 65 and over, currently pays for Leqembi only if patients are enrolled in a clinical trial. The agency said the registry requirement would broaden access to the drug.

It would require doctors to submit evidence on how the drug works in routine practice, and collect information in an “easy-to-use” portal maintained by the Centers for Medicare and Medicaid Services (CMS) upon traditional approval.

“Until CMS announces the registry design and details, it is difficult to understand how a registry will impact patient access to Leqembi should the therapy receive traditional approval from the FDA,” Eisai said in a statement, noting that historically such programs have limited access to patients in underserved communities.

The CMS decision would apply to all Alzheimer’s treatments that reduce a protein called beta amyloid from the brain, including Eli Lilly (NYSE:LLY) and Co’s donanemab, which recently reported positive results from its late-stage trial.

Such “coverage with evidence development” requirements are rare and historically used by Medicare to evaluate medical devices rather than drugs.

“We continue to believe that registry as a condition of coverage is an unnecessary barrier,” the Alzheimer’s Association said in a statement. The group said it supports collecting information on how such treatments work, but that registries should not be a requirement for coverage of an FDA-approved drug.

Biogen’s shares were 2.6% higher at $304.16, while Eli Lilly’s shares rose nearly 1% to $433.14.

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.

Sue Peschin, president and chief executive of the Alliance for Aging Research, said the registry would delay access to treatment.

“Registries take an average of 18 months or more to put together, and the other conditions of coverage will make it tough for the vast majority patients who rely on the program to get an entry ticket,” she said in an emailed statement.