The Italian Medicines Agency conducted an analysis of the authorisation timelines for medicines pricing and reimbursement procedures for the three-year period 2018-2020, with the ultimate aim of monitoring and improving the quality of the service provided.

The study measures the timelines through three indicators: the administrative verification time, which measures the number of days elapsing from the presentation of the application by the pharmaceutical companies to the completion of the administrative verification, the overall duration of the procedure, which measures the time required for completion of the procedure, and finally the time until arrival in the Official Journal, corresponding to the publication of the reimbursement provision and the price of a medicine.

In particular, the administrative verification time in 2018 was on average equal to 17 days if the medicine is non-generic and 10 days if generic, with similar values in 2019, on average respectively 13 and 10 days, with a reduction in 2020, when the value is equal to 6 days for both types of medicine. While the overall duration of the procedure - from the start date to the conclusion date, including the evaluation times by the advisory committees of the Agency (HTA Secretariat, Technical Scientific Committee and Pricing and Reimbursement Committee) in 2018 was on average 275 days if the medicine is non-generic and 91 days if the medicine is generic, with similar values in 2019, respectively 241 and 96 days.

Finally, the time of arrival in the Official Journal, from the date of conclusion of the procedure to the publication in the Official Journal of the related provision, in the year 2018 is on average 78 days if the medicine is non-generic and 71 days if generic. In 2019 it is 61 and 58 days respectively for non-generic and generic medicines.

The data from the analysis were then compared with the timelines of the main European countries reported in a recently published international study ("EFPIA patients W.A.I.T. Indicator 2020 survey", IQVIA, 2020). The comparison shows that AIFA's timeframes are to be considered satisfactory, in fact Italy ranks among the first European countries in terms of medicine authorisation, with an average value of 418 days compared to a European average of 504 days and with a high number of medicines fully reimbursed by the National Health Service.

The analysis methodology used in the study will also provide the Agency with a tool for the continuous monitoring of its administrative action, relating to the reimbursement and price of medicines, with the final aim of optimising its timelines and making medicines available to patients in a timely manner.