The timelines for the price and reimbursement authorization in Italy 2018-2020.

This is the first study to examine the time of the P&R process in Italy, from MAH submission to the publication of the final decision in the Italian Official Journal. The time span considered is 3 years, including the first year of the COVID-19 pandemic. Compared to European average times, in Italy, the time necessary for evaluation, authorization for reimbursement, and definition of the price of a medicine can be considered satisfactory.