[Analysis of the reimbursement times of antitumor drugs in Italy in relation to the clinical benefit expressed by the European Society for Medical Oncology (ESMO-MCBS).]

Rapid access to safe and effective oncological therapies is crucial. In recent years, many expensive drugs have been commercialized, making it essential to prioritize those with significant clinical benefits. For this purpose, the European Society for Medical Oncology (ESMO) introduced the ESMO-MCBS (Magnitude of Clinical Benefit Scale), which assigns a score to quantify the clinical benefit of treatments. This study aims to evaluate whether there is a correlation between the ESMO-MCBS score and drug access times in Italy. The clinical benefit was directly extracted from the official ESMO website, considering registrational trials. Data on drug access times included: the date of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the date of authorization published in the European Official Journal (EU OJ), the date of submission of the drug dossier to the Italian Medicines Agency (AIFA) by the company, the date of opinions issued by AIFA's Technical Scientific Committee and pricing and reimbursement committee, and the date of publication in the Italian Official Journal (OJ). Access time was calculated as the difference in days between the publication dates in the Italian OJ and EU OJ. Subgroup analyses also considered EMA authorization procedures (accelerated approval, conditional marketing), drug classification as "orphan drug," and the innovativeness requirement. The analysis included 48 drugs, corresponding to 57 registrational trials, of which 4 referred to drugs not yet commercialized by AIFA, and 7 did not lead to reimbursement. The evaluation focused on 46 registrational trials. The average access time was 488 days: 480 days for drugs with significant benefit and 499 days for those without significant benefit. For orphan drugs, the average access time was 499 days. Drugs with EMA accelerated assessment showed shorter access times (440 days), while those with conditional marketing approval had longer access times (556 days). Drugs evaluated by AIFA for innovativeness were authorized faster on average. No significant difference in access times was observed between drugs with significant and non-significant clinical benefits. Among the analyzed subgroups, access times are better for drugs with accelerated approval and for which AIFA has expressed an opinion of innovativeness, comparable for drugs designated as "orphan drugs", worse when the EMA authorization occurred as conditional marketing.