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.
These facilities do not exist in the numbers and locations needed to serve all of the US patients eligible for treatment.
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.
Eisai’s early projections are roughly 10,000 patients will start Leqembi before the end of its fiscal year, with 100,000 patients on therapy in three years. The company thinks those numbers are appropriate based upon its assessment of system readiness.

Leqembi Treatment Infrastructure: If Medicare Pays For It, They Will Come

Testing, Infusion Capacity Next Hurdles For Anti-Amyloid Drug