Leqembi Coverage By Veterans Affairs Department Sign Of Success For Eisai’s Payer Engagement Strategy
Alzheimer’s product is following a different playbook than Aduhlem, reflecting better data – and hard-earned lessons. Eisai estimates that 80-90% of veterans who are eligible for Leqembi treatment based on the FDA label would also fit the VA’s criteria.
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The biggest barrier for Eisai/Biogen’s Alzheimer’s medicine Leqembi was Medicare. With full US FDA approval and Medicare coverage in place, PET scan, MRI and infusion centers are needed to facilitate treatment.
CMS will cover Leqembi now that the US FDA has converted Leqembi’s accelerated approval to traditional approval, giving most patients eligible for treatment access to the drug. Updated labeling puts greater emphasis on safety concerns.
While a US FDA advisory committee would focus on efficacy and safety data from Leqembi’s Phase III CLARITY-AD trial, it likely also would provide a public forum for relitigating Audhelm’s accelerated approval and the evidence needed to formally validate amyloid plaque reduction as a surrogate.