The length of price&reimbursement negotiation procedures in Italy in the period 2021-2023 was independent from the price of medicines

Abstract

Background: The duration of price&reimbursement (P&R) procedures is taken as a key performance indicator of Regulatory Agencies in Europe. In this study we have tested the hypothesis that the price of medicines may have negatively affected the duration of P&R negotiations in Italy in the period 2021-2023.

Methods: Data were retrieved from the Intexo database, which included all medicines with EC approval within the period 2021-2023. Biosimilars, generics, gene therapies, Sars-Cov-2 vaccines and medicines with no negotiated price at the datalock of December 2023 were excluded from the analysis. The ex-factory price of the most expensive package was taken as the price of each reimbursed medicine, whereas the time between the publication of EC decision in the European GU and the publication of P&R AIFA decision in the Italian GU (gazette-to-gazette time) as well as the time between the submission of P&R dossier and the publication of AIFA decision in the Italian GU (AIFA negotiation time) were taken as the procedure duration.

Results: Sixty-seven EC approved medicines completed the P&R procedure in Italy within the study period, and had a reimbursed price. The median and mean gazette-to-gazette times were 395 and 442.6 days, respectively, whereas the mean and median AIFA negotiation times were 389.5 and 434.7 days, respectively. The mean price was 10,942 euros. The analysis of correlation between the duration of procedure and the negotiated price showed that there is no correlation whatsoever between the length of procedures and the price of medicines.

Conclusions: We can reasonably exclude that the price of medicines negatively affected the duration of P&R negotiation procedures.