Civitelli, Diego ORCID: 0009-0002-9398-8857, Mills, Mackenzie and Kanavos, Panos
ORCID: 0000-0001-9518-3089
(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.
ISSN 1098-3015
Identification Number: 10.1016/j.jval.2025.04.1080
Abstract
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.
Item Type: | Article |
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Additional Information: | © 2025 Published by Elsevier Inc. |
Divisions: | LSE Health Health Policy |
Subjects: | R Medicine > RA Public aspects of medicine R Medicine > RS Pharmacy and materia medica |
Date Deposited: | 17 Jul 2025 10:18 |
Last Modified: | 17 Jul 2025 10:18 |
URI: | http://eprints.lse.ac.uk/id/eprint/128858 |
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