HPR108 Impact of COVID-19 Pandemic on the Decision Process of the Italian Medicine Agency: A Quantitative Assessment

Abstract

The aim of this study is to assess Covid-19 pandemic impact on drugs’ time to market (TTM) in Italy, defined as the time from the pricing and reimbursement (P&R) dossier evaluation by the Technical Scientific Commission (CTS) to the publication of P&R resolution in the Italian Official Journal. The study included 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 September 2021 and that completed the Italian negotiation pathway. Drugs were clustered into three period groups (Pre-Covid, Partially-Covid and Fully-Covid) according to their negotiation process start and end date. Firstly, kernel density graphs were drawn to visually inspect differences among the three periods. Secondly, descriptive statistics by period and two-sample tests were performed to evaluate the potential role of co-variates influencing TTM. Thirdly, an inferential analysis was performed by implementing a nearest-neighbor matching estimator based on the identified relevant co-variates. Of the 375 drugs receiving a positive opinion in the scrutinized period, 305 were included in the analysis, of which 179, 71 and 55 in the Pre-Covid, Partially-Covid and Fully-Covid period, respectively. Overall, TTM was 317.8 days (SD=219.6), ranging from 237.5 (SD=127.6) days in the Fully-Covid period, to 280.1 (SD=144.5) days in the Pre-Covid period and to 474.9 days (SD=331.6) in the Partially-Covid period. From the matching analysis, Covid-19 impact resulted statistically significant (p<0.01): the average treatment effect of the Partially-Covid period and Fully-Covid period versus the Pre-Covid period was estimated at +138.3 days and -44.8 days, respectively. This study showed that Covid-19 pandemic had a significant impact on drugs TTM in Italy, first lengthening the drugs’ time to Italian market, and then reducing it, underlining the temporary shock for the Italian regulator facing extraordinary epidemiological circumstances.