HTA69 A retrospective analysis of the Italian Medicines Agency’s evaluation of real-world evidence in innovativeness assessments
Civitelli, D.
, Mills, M. & Kanavos, P.
(2025).
HTA69 A retrospective analysis of the Italian Medicines Agency’s evaluation of real-world evidence in innovativeness assessments.
Value in Health,
28(6, Supplement 1), S259.
https://doi.org/10.1016/j.jval.2025.04.1080
, Mills, M. & Kanavos, P.
(2025).
HTA69 A retrospective analysis of the Italian Medicines Agency’s evaluation of real-world evidence in innovativeness assessments.
Value in Health,
28(6, Supplement 1), S259.
https://doi.org/10.1016/j.jval.2025.04.1080
The Italian Medicines Agency (AIFA) assesses the innovativeness of drugs based on unmet need, added clinical benefit, and quality of evidence. The designation provides access to the 1 billion euro Innovative MedicinesFundand faster market access. We investigate the use of Real-World Evidence (RWE) in submissions for innovative status and their appraisal by AIFA.