OBJECTIVES: The therapeutic innovation status aims to grant a rapid and harmonized access to drugs with significant added value. Recently AIFA released a new algorithm for assessing the innovation status, aimed to improve the previous one. The goal of our research is to compare the impact of the old (OldAlg) and the new (NewAlg) innovation rating system on time to reimbursement (TTR), quality and outcomes of evaluation.

METHODS: The analysis considered all the innovative drugs (IDs) (67: 54 with the OldAlg and 13 with the NewAlg) assessed by AIFA. ATC and negotiating condition (i.e. MEAs) have been evaluated. TTR has been defined as days from the European Marketing Authorization to the price publication (Official Journal - GURI).

RESULTS: TTR for IDs trough the OldAlg resulted longer (mean 492 days, range 67-1015) than with the NewAlg, introduced in April 2017 (mean 265 days, range 63-464). Out of 67 innovative drugs, 21 (31%; mean TTR 441 days) were antineoplastics/immunomodulating agents (ATC L), 15 (22%; mean TTR 259 days) antiinfectives systemic use (ATC J) and 15 (22%; mean 720 days) drugs for diabetes (ATC A10). The majority of IDs has been approved with hidden discounts (47%) and/or Managed Entry Agreements (33%). Out of 67 IDs, 60 (90%; 10/13–77% with the NewAlg and 51/54–94% with the OldAlg) received a “full” (36 months duration, access to the new introduced innovative drugs funds, exempt from payback and immediate inclusion in regional formularies) and 7 (10%; 3/13-23% with the NewAlg and 3/54-6% with the OldAlg) a conditional innovative status (18 months duration and immediate inclusion in regional formularies only).

CONCLUSIONS: The new Italian innovation rating system leads to a shorter TTR and to an increased percentage of “conditional innovation” status, allowing a quicker and more sustainable availability of therapeutic valuable drugs for Italian patients.