OBJECTIVES: Analyse trends in drug reimbursement time through tracking the Italian Medicines Agency (AIFA) P&R approval process from submission to publication.

METHODS: This analysis covered evaluation of new active principles approved by EMA and then tracked by AIFA. Data analysed was taken from official documents published on EMA and AIFA websites: EMA approval dates and each single step/checkpoint of the Italian P&R process (dossier submission, scientific assessment by CTS, price negotiation with CPR, publication on Official Journal [OJ]) at AIFA level were tracked monthly from January 2015 to May 2018 through updates of an internal database. The database currently houses 190 drugs. Drugs were categorized into pre-defined categories and analysis was performed by year, by therapeutic area and by approval step.

RESULTS: Up to May 2018, 89 new drugs were reimbursed and categorized in: innovative (17), orphan (23), innovative and orphan (5), oncological (23) and other approved drugs. The analysis showed an average time between CTS opening and OJ publication of 253 days (min 75 max 655), of which 163 due to CTS-CPR active assessment. The average total administrative delay is therefore 190 days (54% of total time). Timing was consistently reduced in all steps for innovative drugs (196 days), while resulted longer for oncological drugs (327 days), particularly the CTS assessment (233 days), which appears slightly shorter compared to previous publications (247,5 days in 2013-2015). Orphan drugs had shorter opening procedures, but longer assessments. Other drugs have longer openings and faster CTS assessments.

CONCLUSIONS: Despite a speed up in the approval process over the last 3 years compared to previous publications, the subanalysis by category reveals a variety of pathways linked to the different categories, impacting on approval timings. The analysis also reveals that most of the overall timing is still linked to administrative steps.