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Lilly Does Not Expect A Quick Medicare Coverage Decision For Donanemab

Eisai Will Make A Case For Lecanemab Soon

 
• By Mandy Jackson

Donanemab may receive accelerated approval for Alzheimer’s disease in early 2023, but Lilly will not approach CMS about Medicare coverage until mid-year when it has Phase III data – and even then does not expect a quick decision. 

health insurance claim form with stethoscope
Gaining Medicare reimbursement will take time even with Phase III data in hand • Source: Shutterstock

Eli Lilly and Company may achieve a landmark drug approval early in 2023 when the US Food and Drug Administration decides whether to grant accelerated approval for its anti-amyloid antibody donanemab in the treatment of early Alzheimer’s disease. But as the company outlined its financial guidance for next year, executives were careful to note that despite the sales potential for what may be a disease-modifying AD therapy, donanemab is not expected to generate significant revenue in 2023.

The biggest hurdle to commercial success in the US for the product – and for Eisai Co., Ltd./Biogen,...

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