From regulatory approval to clinical practice: real-world eligibility for anti-amyloid monoclonal antibodies in an Italian dementia-care network

Abstract

Background: European approval of lecanemab and donanemab has shifted anti-amyloid monoclonal antibodies from trial evidence to health-system implementation. In Italy, reimbursement decisions are pending, and real-world estimates of treatment-ready eligibility under Italian appropriate use recommendations (AUR) incorporating European Medicines Agency (EMA) restrictions are needed.<br><br>Methods: We conducted a retrospective cohort study at the Cognitive Neurology Clinic of the University Hospital of Modena, embedded in the provincial dementia-care network. All patients with at least one visit between Jan 1, 2024, and Dec 31, 2025, were included. Eligibility for lecanemab and donanemab was assessed through a sequential algorithm based on Italian AUR, applying EMA product-label restrictions. Eligibility was estimated across three denominators: the service cohort, the clinical cohort with MCI or mild AD dementia, and the clinical-biological AD cohort.<br><br>Findings: Among 1080 patients, 596 had MCI or mild AD dementia, and 230 had clinical-biological AD. After all eligibility steps, 50 patients were treatment-ready. Eligibility was 4·6% of the service cohort (50/1080; 95% CI 3·5–6·1%), 8·4% of the clinical cohort (50/596; 6·3–10·9%), and 21·7% of the clinical-biological AD cohort (50/230; 16·6–27·6%). After biomarker testing, the largest attrition points were clinical stage, care-context readiness, MRI findings, and APOE-related criteria.<br><br>Interpretation: Even in a biomarker-enabled Italian cognitive neurology network, treatment-ready eligibility is 4·6% of all seen patients. These findings may contribute to the creation of equitable referral pathways by providing empirical denominators for reimbursement assessment and service planning.