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

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 re...

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Autores principales: Xoxi, Entela, Facey, Karen M, Cicchetti, Americo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8386173/
https://www.ncbi.nlm.nih.gov/pubmed/34456724
http://dx.doi.org/10.3389/fphar.2021.699466
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author Xoxi, Entela
Facey, Karen M
Cicchetti, Americo
author_facet Xoxi, Entela
Facey, Karen M
Cicchetti, Americo
author_sort Xoxi, Entela
collection PubMed
description 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 registries, 182 are appropriateness registries (35.2% relate to OMPs, with an almost equal split of cancer vs. non-cancer for OMPs and MPs), 35 include financial-based agreements [20% OMPs (2 non-cancer, 5 cancer)], and 60 registries are payment by result agreements [23.3% OMPs (4 non-cancer, 10 cancer)]. Most OMPs (53/88) came through the normal regulatory route. With the strengthening of the system for evaluation of innovation, fewer outcomes-based registries have been instigated. AIFA has overcome many of the challenges experienced with MEA through developing an integrated national web-based data collection system: the challenge that remains for AIFA is to move from using the system for individual patient decisions about treatment to reviewing the wealth of data it now holds to optimize healthcare.
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spelling pubmed-83861732021-08-26 The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy Xoxi, Entela Facey, Karen M Cicchetti, Americo Front Pharmacol Pharmacology 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 registries, 182 are appropriateness registries (35.2% relate to OMPs, with an almost equal split of cancer vs. non-cancer for OMPs and MPs), 35 include financial-based agreements [20% OMPs (2 non-cancer, 5 cancer)], and 60 registries are payment by result agreements [23.3% OMPs (4 non-cancer, 10 cancer)]. Most OMPs (53/88) came through the normal regulatory route. With the strengthening of the system for evaluation of innovation, fewer outcomes-based registries have been instigated. AIFA has overcome many of the challenges experienced with MEA through developing an integrated national web-based data collection system: the challenge that remains for AIFA is to move from using the system for individual patient decisions about treatment to reviewing the wealth of data it now holds to optimize healthcare. Frontiers Media S.A. 2021-08-10 /pmc/articles/PMC8386173/ /pubmed/34456724 http://dx.doi.org/10.3389/fphar.2021.699466 Text en Copyright © 2021 Xoxi, Facey and Cicchetti. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Xoxi, Entela
Facey, Karen M
Cicchetti, Americo
The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy
title The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy
title_full The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy
title_fullStr The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy
title_full_unstemmed The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy
title_short The Evolution of AIFA Registries to Support Managed Entry Agreements for Orphan Medicinal Products in Italy
title_sort evolution of aifa registries to support managed entry agreements for orphan medicinal products in italy
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8386173/
https://www.ncbi.nlm.nih.gov/pubmed/34456724
http://dx.doi.org/10.3389/fphar.2021.699466
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