Procedural activity and dynamics of the new Italian Scientific and Economic Committee (CSE): a one-year observational analysis

Introduction: In January 2024, the Commissione Scientifica ed Economica (CSE) became the national body responsible for the integrated scientific and economic evaluation of medicines in Italy. This study provides the first systematic description of the CSE's activity during its initial operational year, focusing on procedural workload, timelines, and negotiation outcomes. Methods: All publicly available "Esiti CSE" documents published by the Italian Medicines Agency (AIFA) between April 2024 and April 2025 were manually extracted and validated. Each record included the negotiation typology (TN-1 to TN-8), outcome, and iter duration. Descriptive analyses summarised distributions, median and mean durations, deferral rates, and trends over time. Results: A total of 641 procedures (523 products, 446 INNs) generated 2,145 individual outcomes. Argomento rinviato (deferral) was the most frequent outcome (55.7% of all decisions; 51% of procedures). The average procedure involved 1.9 deferrals, and 83% experienced at least one. Mean overall duration was 269 days (median 196; IQR 133-350), with the longest timelines for TN-1 and TN-4 negotiations (298 and 322 days, respectively). Oncology (L01, L04) and metabolic agents (A10) showed the greatest variability, while antivirals (J05) recorded the longest average duration (549 days) but a lower incidence of deferral. Conclusions: The first year of CSE activity reveals a high workload, variable timelines, and frequent deferrals, reflecting the complexity of integrating scientific and economic assessment within a single body. The results provide an empirical baseline for future monitoring and underscore the need for refinement of governance arrangements and procedural transparency in AIFA's new framework.