For Alzheimer’s Drug Leqembi, Coverage Hinges on Full FDA Approval

  • Jan 12, 2023

    Via the FDA’s accelerated approval pathway, Biogen and Eisai got the green light from federal regulators on Jan. 6 to take their Alzheimer’s drug Leqembi (lecanemab) to market. But sources tell AIS Health, a division of MMIT, that uptake and coverage of the medication will likely be underwhelming until it receives full FDA approval — a designation the manufacturers have already filed to acquire. 

    Leqembi represents the drugmakers’ second crack at offering a breakthrough Alzheimer’s drug, as they launched Aduhelm (aducanumab) in 2021 after it received its own accelerated approval nod despite considerable controversy over the medication’s safety and efficacy. Both drugs are monoclonal antibodies that aim to slow cognitive decline in Alzheimer’s patients by reducing amyloid plaque buildup on the brain of patients in early stages of the disease.  

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  • Leslie Small

    Leslie has been working in journalism since 2009 and reporting on the health care industry since 2014. She has covered the many ups and downs of the Affordable Care Act exchanges, the failed health insurer mega-mergers, and hundreds of other storylines spanning subjects such as Medicaid managed care, Medicare Advantage, employer-sponsored insurance, and prescription drug coverage. As the managing editor of Health Plan Weekly and Radar on Drug Benefits, she writes and edits for both publications while overseeing a small team of reporters who also focus on the managed care sector. Before joining AIS Health, she was a senior editor for the e-newsletter Fierce Health Payer, and she started her career as a copy editor at multiple local newspapers. She graduated with a dual degree in journalism and political science from Penn State University.

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