The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy.

ABSTRACT: Italy has a well-established prominent system of national registries to support managed entry agreements (MEAs), monitoring innovative medicinal products (MPs) with clinical as well as economic uncertainties to ensure appropriate use and best value for money. The technological architecture of the registries is funded by pharmaceutical companies, but fully governed by the national medicines agency (AIFA). A desktop analysis was undertaken of data over a 15-year timeframe of all AIFA indication-based registries and associated EMA information. The characteristics of registries were evaluated, comparing orphan MPs vs. all MPs exploring cancer and non-cancer indications. OMP (orphan medicinal product) registries' type vs. AIFA innovation status and EMA approval was reviewed. Of the 283 registri

SUBMITTER: Xoxi E 

PROVIDER: S-EPMC8386173 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature