OBJECTIVES:

To observe the duration of the assessment phase of new drugs during the P&R process at the Italian Medicines Agency (AIFA), in the period covering the last mandate of the committees (between 2018 and 2022), in order to identify potential influencing variables.

METHODS:

A specific internal database was developed in Microsoft Excel by MA Provider and constantly updated. The database was populated with information related to all new drugs approved by the European Medicines Agency. The assessment phase (from the opening of the CTS procedure to the CPR outcome) of each medicine has been tracked through Official Journals and AIFA committee outcomes from October 2018 to June 2022.

RESULTS:

The P&R process was concluded for 93 new medicines. The average duration of the assessment phase was 257 days (n=93; SD±139), a significant increase compared to the timelines of the previous committees in the three-year period 2015-2018 (180 days, n=63, SD±127; p=0.0006).

28% (25/93) of the analysed drugs were innovative and 19% (18/93) had a managed entry agreement.

A longer assessment time was observed for innovative drugs (295 days, n=25; SD±109), although not statistically significant compared to non-innovative drugs (244 days, n=68; SD±146; p=0.1145). A significant variation was observed for drugs with a MEA applied (357days, n=18, SD±173 vs 233 days, n=75, SD±118; p= 0.0005).

A sub-analysis of non-innovative drugs with MEAs shows an even longer duration of assessment (407days, n=8, SD±222) vs non-innovative drugs without MEAs (222days, n=60, SD±119; p=0.0005).

CONCLUSIONS:

Over the past 45 months, we have observed an increase in overall assessment timelines of approximately 2.6 months. Among the potential drivers for this delay, it appears that the application of MEAs might be a discriminating factor. However, also the additional effort required and delays due to the pandemic condition must be considered.