The Italian Medicines Agency has carried out an updated analysis of the time to authorisation of pharmaceutical pricing and reimbursement (P&R) procedures in the period 2018-2021, with the aim of monitoring and improving the quality of the service rendered.

The study measures such time through five indicators, of which the first two are a novelty compared to the previous report. The first new indicator is the time between the date of the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) for a centrally authorised medicine, and the date of decision by the European Commission (EC). The second new indicator is the time between the date of the EC decision and the date of submission of the P&R application to AIFA. The third indicator is the administrative check, which measures the number of days between the submission of the application by pharmaceutical companies and the actual completion of the administrative check. The fourth indicator is the overall duration of the procedure, which measures the time required for its conclusion, including the assessment by the HTA Office and AIFA’s advisory committees. Finally, the fifth indicator is time to the sending of the final decision for publication in the Official Gazette, which measures the days between the date of approval by the Board of Directors, including the issuing of the decision and the notification to companies, and the sending of the final P&R decision for publication in the Official Gazette.

During 2018-2021, the time between the date of the CHMP opinion and the date of the EC decision was on average around 2 months for non-generic medicines and around 2-3 months for generics, with greater variability for procedures related to non-generic medicines.

During 2018-2021, the time between the date of the EC decision and the date of submission of the P&R application by the pharmaceutical company was on average around 10-12 months for non-generic medicines and around 7-12 months for generics, with heavy time variability for both types of pharmaceuticals.

The time for the administrative check was the most successful, with an average of 8 days during 2018-2021, with a decreasing trend up to 2 days for generics and to 5 days for non-generic medicines in 2021.

The overall duration of procedures - from start to closing, including the assessment by AIFA’s HTA Secretariat, Scientific-Technical Commission and Prices and Reimbursement Committee - decreased from 2018 to 2020, from an average of 9 to 8 months for non-generic medicines, and around 3 months for generics.

The time to the sending of the final decision for publication in the Official Gazette - from the date of conclusion of the procedure to the sending of the document to the Official Gazette - showed a decreasing trend over time. It went from just over 2 months in 2018 to 2 months in 2020, both for generic and non-generic medicines.

The data resulting from the analysis were then compared with the times recorded in the main European countries, as reported in a recently published international study (“EFPIA patients W.A.I.T. Indicator 2021 survey”, IQVIA, April 2022). The comparison shows that AIFA’s times can be considered satisfactory. Italy ranks among the first European countries for authorisation of medicinal products, with an average of 429 days compared to a European average of 511 days, and against a large number of medicines totally reimbursed by the National Health System.

The analysis carried out also takes into account that procedure times were affected by two years of COVID-19 pandemic.

The methodology used in this study will provide the Italian Medicines Agency with a tool for continuously monitoring its administrative action in the field of pricing and reimbursement of medicines, with the ultimate aim of optimising its times and making medicines promptly available to patients.

Published on: 13 April 2022