Time to market evaluation for new chemical entities in Italy: a critical analysis of the period 2018-2024

• Published in: Global & Regional Health Technology Assessment
• Main Authors: Alessandro Tedesco, Marzia Bonfanti, Asia Barugolo, Fulvio Luccini, Patrizia Berto
• Format: Article
• Language: English
• Published: AboutScience Srl 2025-05-01
• Subjects: Italy; Orphan drugs; Pricing; Rare diseases; Time-to-market
• Online Access: https://journals.aboutscience.eu/index.php/grhta/article/view/3422

Objective: This study aims to provide an up-to-date analysis, for new chemical entities on the market, on the timing of pricing and reimbursement (P&R) in Italy, covering the entire period of activity (from September 2018 to January 2024) of the last evaluation Commission (Technical Scientific Committee, CTS, and Price and Reimbursement Committee, CPR). Methods: The data used in this analysis were obtained from public official websites. The information was systematically collected to investigate the days required to complete the P&R process. The analysis was stratified into indications for rare diseases, orphan designation, innovation assessment, and anatomical therapeutic chemical (ATC) class L. Mann-Whitney U test was used to study the significance of the difference. A p-value < 0.05 was considered significant. Results: Overall, 180 procedures were included in the final analysis. The median duration of the entire process, from MAH submission to final Gazette publication, was of 439.5 days. The timelines varied among the analyzed drug classes. Rare disease drugs (n = 78) had a longer timeline than non-rare-disease drugs (n = 102) (462.0 days vs 419.5 days, respectively). Among rare disease procedures, orphan designation was a predictor for time prolongation (orphan drugs, n = 66, 462.0 days vs 443.0 days non-orphan drugs, n = 12). Innovativeness status was associated with a shorter timeframe (-14 days), as was the ATC L classification (-68 days). Conclusion: The results indicate a methodological consistency with previous studies, suggesting a continuity of analysis, despite the increase in the complexity of evaluations and the number of drugs treated.