Eisai Co., Ltd. and its partner Biogen, Inc. crossed over the biggest barrier in their quest to commercialize Leqembi (lecanemab) now that Medicare will cover the cost of the Alzheimer’s disease drug. The next hurdles for doctors and patients will be obtaining blood tests and PET scans for confirming amyloid pathology in the brain, genetic testing to assess APOE4 status, MRIs to monitor for amyloid-related imaging abnormalities (ARIA) and infusion centers to administer the medicine – facilities that exist, but not in the numbers and locations needed to serve all of the US patients eligible for treatment.
KEY TAKEAWAYS
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Leqembi requires blood tests and PET scans to confirm amyloid pathology in the brain, genetic testing to assess APOE4 status, MRIs to monitor for amyloid-related imaging abnormalities (ARIA) and infusion centers to administer the medicine.
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These facilities do not exist in the numbers and locations needed to serve all of the US patients eligible for treatment.
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Blood tests are emerging that can predict amyloid presence that may help doctors determine when to pursue PET scans or CSF testing and Leqembi treatment for dementia patients
The Centers for Medicare and Medicaid Services (CMS) said that it will cover the cost of Leqembi on 6 July, the day that the US Food and Drug Administration converted the amyloid protofibril-targeting antibody’s accelerated approval for the treatment of mild cognitive impairment or mild dementia associated with Alzheimer’s disease (AD) into full approval
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