Background: Since the COVID-19 pandemic has placed more attention on drugs’ approval process and the importance of rapid decision-making in the healthcare sector, it is crucial to assess how time to market (TTM) of drugs varied. Objective: To estimate the impact of the COVID-19 pandemic on TTM of drugs in Italy. Methods: An IQVIA database was used to retrieve information on drugs that obtained positive opinion from the Committee for Medicinal Products for Human Use between January 2015 and December 2021. The available observations were divided into three groups (Pre COVID, Partially COVID, and Fully COVID) according to the timing of their negotiation process. Differences in average TTM among the three groups were analyzed in three steps: (1) descriptive statistics; (2) univariate analysis; (3) multivariate analysis, using a matching estimator. Results: A total of 363 unique combinations of molecule and indication met the inclusion criteria: 174 in the Pre COVID group, 69 in the Partially COVID group, and 123 in the Fully COVID group. Descriptive statistics and univariate analysis found a statistically significant difference in TTM among the three periods, with average TTM increasing during the pandemic (+136 days, p = 0.00) and then decreasing afterward (−23 days, p = 0.09). In the matching analysis, results for the Partially COVID period were confirmed (+108 days, p = 0.00) while results for the Fully COVID period lost significance but maintained a negative sign. Conclusions: The results suggest that after an adjustment phase in the Partially COVID period, a return to the status quo was reached.

Introduction: This study estimates the change in the costs of second-line or later (2L+) treatments compared to the current scenario, associated with the introduction of brentuximab vedotin (Adcetris®) (BV) in combination with doxorubicin, vinblastine and dacarbazine (A+AVD) for the treatment of previously untreated (1L) patients with stage IV classical Hodgkin’s lymphoma (cHL). Methods: An economic model has been developed that estimates the variation in treatment costs of 2L+ associated with the introduction of BV in 1L from the point of view of the Italian National Health System over a time horizon of 3 years. The population eligible to receive a treatment of 2L+ has been estimated from the literature, considering an increasing consumption in the three years of A+AVD in 1L. Two main scenarios and several alternative scenarios were considered to address the uncertainty that characterizes the distribution of market shares of 2L+ treatments. Results: In the baseline scenario, over three years, the introduction of BV in 1L is associated with a cumulative reduction in treatment costs of 2L+ of € 1.74 M. In all scenarios, a reduction in treatment costs of 2L+ is confirmed, with a total saving that varies between € 5.6 M and € 1.3 M compared to the main scenarios. Conclusions: The present analysis shows that the introduction of A+AVD in 1L for the treatment of stage IV CD30+ cHL patients is associated with a reduction in treatment costs of 2L+, even if there are some limitations related to the uncertainty of real cost and population estimates.