COVID-19 impact on the decision process of the Italian Medicine Agency: a quantitative assessment

Background: Since the COVID-19 pandemic has placed more attention on drugs' approval process and the impor-tance 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 ob-servations 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.