More and earlier data from AIFA: do they impact on the regional policies? Results from an exploratory analysis

In Italy, drug prices and reimbursement are managed by the Italian Medicines Agency (AIFA), but regions actually enable patient access to medicines. Our aim is to provide evidence on (i) the current management of regional pharmaceutical policies, the use of resources and time to policy completion (TPC-procurement awarding), (ii) the potential impact on resources used and TPC of an earlier-enhanced access of regions to AIFA's data.

Four regions (Veneto, Emilia-Romagna, Campania, Puglia) were selected on a purposive basis. Data on policies and resources used were retrieved from a literature review and interviews with regional officers. TPC was tracked for medicines approved for reimbursement in Italy from January 2023 to June 2024. The potential impact of an earlier-enhanced access to AIFA's data was detected through perceptual questionnaires self-compiled by regional officers.

To manage regional access, the regions employ a staff of 21 Full-Time-Equivalent (FTE) persons on average, ranging from 11 to 29. The mean TPC ranges from 135 to 361. The average score of perceived impact of an earlier-enhanced AIFA's data equals 3.3 within a range of 1-4 for both FTE and TPC. An earlier access to public information (e.g., innovativeness appraisal) is perceived as impactful on TPC. Availability of data that are currently not shared with regions may have a greater potential impact on FTE.

A great consensus emerged on the importance of timely access to revised P&R data. Systematic early disclosure by AIFA could help to improve efficiency in resource utilization and to expedite patient access to innovative medicines.