Italian Medicines Agency's reform and time until pricing and reimbursement decisions: a time-to-event analysis

Introduction: The duration of pricing and reimbursement (P&R) negotiations is a key performance indicator for medicines agencies in universal health coverage systems. In early 2024, the Italian Medicines Agency (AIFA) underwent a major reform, including the merging of the previous Scientific-Technical Committee and Price and Reimbursement Committee into a single Scientific and Economic Committee. This study evaluates the reform's impact on time to P&R determinations for new medicines in Italy. Methods: A time-to-event analysis was conducted on 139 new chemical entities authorized by the European Commission (EC) between February 2021 and December 2023. The primary outcome was the time from marketing authorization (MA) to publication of AIFA's P&R determination. Kaplan-Meier curves and Cox proportional hazards models were used to compare reclassification hazards between pre-(before March 2024) and post-reform groups of medicinal products, based on a fixed separation date, adjusting for antineoplastic therapeutic area and pharmaceutical company size. Four sensitivity analyses tested the robustness of the results. Results: The multivariate Cox model, adjusting for antineoplastics, products from major corporations, and orphan medicines, showed that the reform was associated with an 84% increase in reclassification hazards (HR = 1.84, 95% CI 1.20-2.82, p = 0.005). Sensitivity analyses corroborated these findings, showing even greater improvements when focusing on national evaluation timeframes (HR = 11.57 and HR = 3.91). Conclusion: The consolidation of separate committees into a unified structure, as a part of the 2024 AIFA reform, was accompanied by accelerated P&R negotiations for new medicines in Italy, demonstrating that structural optimization of health technology assessment processes may enhance system efficiency. Keywords: AIFA, Health Services Accessibility, Pricing and reimbursement, Pharmaceutical policy, Pharmaceutical preparations, Survival Analysis