The company believes the Phase III Clarity AD results offer a high level of evidence that may convince the Centers for Medicare and Medicaid Services to change its stance on anti-amyloid antibodies for lecanemab. 

Ivan Cheung, Eisai’s US CEO, explains the ‘question-by-question’ the company is taking to convince the Centers for Medicare and Medicaid Services that its Phase III Clarity AD results in Alzheimer’s offer the ‘high level of evidence’ needed for smooth reimbursement of lecanemab.

While Phase III results for Eisai and Biogen’s lecanemab show amyloid clearance provides benefit and Roche’s Phase III gantenerumab data are supportive, more data and certainty of access to treatment are needed.

Lilly’s donanemab showed faster, deeper amyloid clearance versus Biogen/Eisai’s Aduhelm and Roche’s failed Phase III gantenerumab studies showed the importance of deep, rapid removal.

Alzheimer’s patients treated with the amyloid protofibril-clearing antibody had slower disease progression compared to placebo, with differences increasing over time. Safety concerns, however, are growing. 

Phase III results for Eisai/Biogen’s lecanemab are the main event at the Clinical Trials on Alzheimer’s Disease meeting, but other data – even Roche’s failed Phase III gantenerumab studies – also may have implications for the amyloid-clearing antibody.