OBJECTIVES: The aim of this study is to update previous research on time to market (TTM) in Italy and evaluate the Covid-19 pandemic impact on drugs’ TTM in an expanded timeframe (2015-2022 vs 2015-2021), to provide a more comprehensive assessment of the work of the Italian Medicines Agency committees ahead of the reform foreseen in the next months.

METHODS: The analysis was updated to include all the new active substances, excluding vaccines, that received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) between January 2015 and December 2022 and that completed the Italian negotiation pathway. Firstly, drugs were clustered into the Pre-Covid, Partially-Covid and Fully-Covid groups depending on the timing of their negotiation process. Differences in TTM among the three periods were inspected visually and through descriptive statistics, and two-sample tests were performed to evaluate the potential role of co-variates influencing TTM. Then, a nearest-neighbor matching estimator analysis was implemented based on the identified relevant co-variates.

RESULTS: In 2022, 24 new drugs met the inclusion criteria for the analysis, bringing our sample to 387 unique combinations of molecule and indication. Descriptive analyses showed a difference in TTM only for the Partially-Covid period (average TTM: 435.7 days), while no difference was observed between the Fully-Covid vs Pre-Covid periods (average TTM: 283.7 and 283.2 days). Inferential analysis confirmed the results from the previous study: the average treatment effect of the Partially-Covid period was +124.6 days (p=0.00) (vs. +108.0 days [p=0.00] in the 2015-2021 timeframe), with moderate variation resulting from sensitivity analyses (101.0-138.7 days; p=0.00).

CONCLUSIONS: This study confirmed previous evidence on the impact of Covid-19 on drugs TTM in Italy: while TTM increased significantly during the pandemic, it decreased back to its pre-pandemic averages in the Fully-Covid period, highlighting the temporary nature of the shock.