OBJECTIVES: Access to reimbursed drugs in Italy involves a three-phase regional process: inclusion in the Regional Therapeutic Hospital Formulary (PTOR), identification of authorized prescribing centers, and tendering. These phases vary across regions, creating temporal barriers to patient access. The objective of this analysis is to identify different factors impacting regional access

METHODS: An Excel database included 184 procedures (new substances and indication extensions) was created. Access timelines were recorded for all regions from publication in the Official Journal (GU) to tendering. Procedures approved from December 11, 2019, to September 16, 2022, with retrievable information, were included. Sources used: Regional Official Bulletins, Regional Pharmaceutical Services websites, and Central Procurement Authorities. Data collected: procedure type, rare disease procedures, recognition of innovation, GU and regional publication dates. Mean and range (MIN - MAX) in days from GU to tendering were calculated.

RESULTS: The analysis covered 91 indications (49% of the total) during the analyzed period. The average regional access time from GU publication was 65.65 days (range: 1-773). Indication extensions had shorter access times than new substances (Mean: 67 days, range: 11-222 vs. Mean: 112 days, range: 20-298). Average access times increase for rare diseases compared to non-rare diseases for new substances (Mean: 95 days, range: 22-234 vs. Mean: 99 days, range: 18-322) and decrease if innovation is recognized (Mean: 68 days, range: 6-169 for innovative substances vs. Mean: 144 days, range: 34-476 for non-innovative substances).

CONCLUSIONS: Regional processes, rather than regional epidemiology, influence access time. The pathway is partially influenced by drug characteristics. Indication type impacts access to new substances (the insertion ex novo in tenders lengthens the process). Indication extensions have shorter timelines (due to previous tenders). Innovative and/or rare disease drugs have a more favorable position compared to non-innovative non-orphan drugs.