Global & regional health technology assessment · 2026
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Canto Benedetta Dal, Benedetto Vera, Martelli Alma, Scroccaro Giovanna, Vinci Bruna
Аннотация
INTRODUCTION:: Timely access to new medicines is a key dimension of health system performance. In Italy, pricing and reimbursement decisions are taken by the Italian Medicines Agency (AIFA). In 2024, a reform established the Scientific and Economic Commission (CSE), integrating the former Technical-Scientific Committee and Pricing and Reimbursement Committee into a single decision-making body. This study evaluates whether the introduction of the CSE is associated with changes in the duration of the price and reimbursement process.
METHODS:: An observational pre-post study was conducted using publicly available AIFA regulatory data. New chemical entities and orphan medicines under negotiation type 1 reimbursed between January 2022 and January 2026 were included. Time intervals were reconstructed from official AIFA committee agendas and compared between pre-reform (CTS/CPR) and post-reform (CSE) periods. Differences were assessed using the Wilcoxon rank-sum test.
RESULTS:: The sample included 71 medicines (30 pre-reform; 41 post-reform). The median duration of the evaluation and negotiation phase decreased from 195 to 119 days after the introduction of the CSE (p < 0.004). Overall time to publication also decreased but not significantly. Administrative timelines remained stable.
CONCLUSIONS:: The CSE was associated with a significant reduction in evaluation-negotiation timelines, suggesting improved efficiency in the phase targeted by the reform. However, no significant reduction was observed in overall timelines, indicating persistent delays in downstream administrative phases.
METHODS:: An observational pre-post study was conducted using publicly available AIFA regulatory data. New chemical entities and orphan medicines under negotiation type 1 reimbursed between January 2022 and January 2026 were included. Time intervals were reconstructed from official AIFA committee agendas and compared between pre-reform (CTS/CPR) and post-reform (CSE) periods. Differences were assessed using the Wilcoxon rank-sum test.
RESULTS:: The sample included 71 medicines (30 pre-reform; 41 post-reform). The median duration of the evaluation and negotiation phase decreased from 195 to 119 days after the introduction of the CSE (p < 0.004). Overall time to publication also decreased but not significantly. Administrative timelines remained stable.
CONCLUSIONS:: The CSE was associated with a significant reduction in evaluation-negotiation timelines, suggesting improved efficiency in the phase targeted by the reform. However, no significant reduction was observed in overall timelines, indicating persistent delays in downstream administrative phases.