The Italian Assessment System for Innovative Medicines: An 8-Year Retrospective Analysis of Outcomes, Criteria, Timelines and Funding Dynamics
The Italian system has been applied consistently over time, with appraisal outcomes largely reflecting the formal decision criteria rather than regulatory status. The 2025 reform may represent a turning point, potentially changing designation patterns and their determinants. Ongoing monitoring is needed to ensure access does not compromise evidence standards or sustainability, offering lessons that may be relevant to other health systems considering similar mechanisms.
Authors
- G. Polito (ORCID: https://orcid.org/0009-0004-6158-1045)
- Lorenzo Martellone (ORCID: https://orcid.org/0000-0002-4921-8778)
- Camilla Servidio (ORCID: https://orcid.org/0000-0002-3908-5086)
- Marcello Vaccaro (ORCID: https://orcid.org/0009-0008-3931-576X)
- Adriana Coluccia (ORCID: https://orcid.org/0009-0004-5090-6932)
- Katiuscja Malandrini
- Claudio Maria Mastroianni
- Alessandra Oliva
Institutions
- Policlinico Umberto I (IT)
- Sapienza University of Rome (IT)
Publication Details
- Journal
- Applied Health Economics and Health Policy
- Published
- 2026-03-04
- DOI
- https://doi.org/10.1007/s40258-026-01032-8
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00