In relation to information released by some news agencies concerning the opinion expressed by the AIFA Scientific and Economic Committee (CSE) on the reimbursement of the medicines lecanemab and donanemab (Leqembi and Kisunla) for the treatment of Alzheimer’s disease, the Italian Medicines Agency wishes to clarify the following:

When assessing reimbursement dossiers, the CSE operates independently, analysing the technical and scientific aspects related to the efficacy and safety of medicines, their benefit–risk profile, the added value compared with treatments already reimbursed, and the economic impact on the National Health Service. The balance of these factors underpins decisions made in the interest of all citizens and with full awareness of the significant clinical needs associated with Alzheimer’s disease.

Specifically, the evaluation process for the two medicinal products has not yet been definitively concluded, and any interim negative assessments issued by the Committee may be subject to further review. Once the procedure has been formally completed, the Agency will publicly communicate the outcome.