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Blog #2 What's the point of developing a life-changing drug, if most people don't have access to it?

Updated: Apr 2, 2023

Recently, the US Food and Drug Administration (FDA) granted accelerated approval of Lecanemab, an anti-amyloid antibody for people with early Alzheimer's disease (mild cognitive impairment or mild dementia due to Alzheimer's disease). FDA will determine their full approval possibly in this summer. Lecanemab's 18-month clinical phase 3 trial demonstrated less cognitive and functional decline in the Lecanemab group, compared to the placebo group*1. Although they still have to examine its adverse events and safety of Lecanemab, maybe, this can be the drug that we have been waiting for a long time? If so, I hope that the US Centers for Medicare & Medicaid Services (CMS) revisit their decision of the coverage for the class of anti-amyloid monoclonal antibodies such as Lecanemab, limiting reimbursement only to people in clinical studies*2. This drug will cost about $26,500 a year*3. Yes, $26,500!! What is the point of developing a new drug that can possibly help so many people if you make it not accessible?

*1. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948

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