OBJECTIVES: this work analyzed the P&R timing for new therapeutic indications of a drug already reimbursed in the Italian market. In addition, the percentage of discount granted to the new indications was calculated, based on the analysis of the net prices indicated in the regional tenders. The data obtained were compared with those reported in the available literature.

METHODS: a database was created to monitor sources, timings, and prices. The timeframes were divided into 8 procedural STEPS: the first STEP coincides with EMA’s CHMP opinion and the last corresponds to the end of the P&R process (i.e. Italian OJ publication). The significance of the differences (p-value) was calculated using Mann-Whitney’s U-test.

RESULTS: of the 81 extensions initially considered in this paper, only 42 met the inclusion criteria and were included in the analysis. The average time to complete the whole process, starting from the CHMP opinion to the publication in the Italian OJ, is 507.3 days, compared to 415 days to complete the process for new medicinal products. The CPR (Price and Reimbursement Commission) assessment time is longer both for orphan (p=0.0319*) and for rare disease drugs (0.0032*). New indications reimbursed with conditional innovativeness take a longer CPR time than new indications reimbursed with full innovativeness (p=0.0336*). The average confidential discount obtained by AIFA following the extension of indication was 12% compared to the 25.1% discount for new medicines; furthermore, a lower discount was observed for new indications reimbursed with a MEA (Managed Entry Agreement) (p=0.0067*).

CONCLUSIONS: in this study, we observed that all the timeframes considered (e.g. overall duration of the procedure, duration of AIFA assessment, timeframe for submission of the P&R application) are generally longer for new indications procedures than for new medicines procedures. Moreover, the confidential discounts obtained for new indications are significantly lower than those obtained for new medicines.