Good practices for the development of budget impact models at regional level

Authors

  • Andrea Marcellusi Economic Evaluation and HTA (EEHTA-CEIS), Università degli Studi di Roma “Tor Vergata”, Roma https://orcid.org/0000-0002-3974-3798
  • Angela Ragonese Economic Evaluation and HTA (EEHTA-CEIS), Università degli Studi di Roma “Tor Vergata”, Roma https://orcid.org/0000-0002-0919-7837
  • Andrea Marinozzi Farmacia Ospedaliera, ASL 4 Teramo, Teramo
  • Alberto Bortolami Istituto Oncologico Veneto IRCCS Padova, Padova
  • Sara Mucherino CIRFF- Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione, Dipartimento di Farmacia, Università degli studi di Napoli Federico II, Napoli https://orcid.org/0000-0003-3357-5655
  • Carolina Moreno Value & Access Specialist, Regulatory Pharma Net, Pisa
  • Amalia Antenori Lead Pricing, Reimbursement & Access, Eli Lilly Italy Spa, Roma
  • Matteo Ferrario Integrated Access Lead, Roche Spa, Monza (MB) https://orcid.org/0009-0007-3961-9985
  • Claudia Simonelli Study and Scientific Solutions, Medtronic Clinical & Regulatory Solutions (MCRS), Roma
  • Matteo Zanuzzi Agenzia Italiana del Farmaco, Ufficio Valutazioni Economiche, Roma
  • Marco Cicoira Dipartimento del Farmaco, ASP Trapani, Trapani https://orcid.org/0009-0005-0950-2765
  • Ruggero Lasala Farmacia Ospedaliera, Corato, ASL Bari, Bari https://orcid.org/0000-0003-2411-8743
  • Francesco Russoniello Dipartimento Farmaceutico, ASL Napoli 1 Centro, Napoli
  • Francesco Attanasio Politiche del Farmaco, Regione Toscana, Firenze
  • Caterina Donati IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, (FC) https://orcid.org/0000-0002-7076-3340
  • Chiara Roni Direzione Centrale Salute, Politiche Sociali e Disabilità, Assistenza Farmaceutica, Regione Autonoma Friuli-Venezia Giulia, Trieste https://orcid.org/0009-0003-1258-017X
  • Fabrizio Gemmi Agenzia Regionale di Sanità della Toscana, Firenze https://orcid.org/0000-0002-1266-8433
  • Francesco Saverio Mennini EEHTA CEIS, Facoltà di Economia, Università degli Studi di Roma “Tor Vergata”, Roma, Presidente SiHTA
  • Pierluigi Russo Direttore Ufficio Valutazioni Economiche e Ufficio Registri di Monitoraggio, Italian Medicine Agency (AIFA), Roma https://orcid.org/0000-0003-4881-5703
  • Giovanna Scroccaro Direzione Farmaceutico-Protesica Dispositivi Medici, Area Sanità e Sociale, Regione del Veneto, Venezia https://orcid.org/0000-0002-6438-8521
  • PierLuigi Canonico Department of Pharmaceutical Sciences, Università del Piemonte Orientale; Presidente ISPOR Italy Rome Chapter, Novara - Italy

DOI:

https://doi.org/10.33393/grhta.2023.2582

Keywords:

Best practices, Budget impact analysis, ISPOR

Abstract

Introduction: The present work aims to discuss the current scenario of procedures and regulations regarding budget impact analysis/models (BIA/BIM) at regional level in Italy and to provide a standardized approach and detailed recommendations for developing these analyses.

Method: A systematic review of the literature was conducted in order to collect existing guidelines or specific regional procedures for budget impact analysis in Italy. All the records were analysed in qualitative terms according to a pre-specified analytical framework, based on the ISPOR BIA guidelines. At the end of the analysis, a consensus questionnaire was developed to establish agreed approaches and to provide possible solutions to any critical issues. A list of 39 statements was developed. The survey was distributed to 69 experts who rated their level of agreement with each statement on a 5-point Likert scale. Consensus was predefined as more than 66% of the panel agreeing/disagreeing with any given statement.

Results: Sisty-nine experts answered the questionnaire; a total of 30/39 statements achieved consensus. There was agreement on most of the statements. Time horizon to consider and costs were the issues on which no agreement was found. The results allowed the working group to define a list of good practices.

Conclusion: While the structure and development of BIM are now well-known and well-applied at national level, there remains a great diversity of management of BIM tools at regional level. Consensus was reached among participating experts, as to the main characteristics, determinants and features of regional BIA/BIM in the perspective of the Italian payer.

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Additional Files

Published

2023-06-26

How to Cite

Marcellusi, A., Ragonese, A., Marinozzi, A., Bortolami, A., Mucherino, S., Moreno, C., Antenori, A., Ferrario, M., Simonelli, C., Zanuzzi, M., Cicoira, M., Lasala, R., Russoniello, F., Attanasio, F., Donati, C., Roni, C., Gemmi, F., Mennini, F. S., Russo, P., Scroccaro, G., & Canonico, P. (2023). Good practices for the development of budget impact models at regional level. Global and Regional Health Technology Assessment, 10(1), 53–61. https://doi.org/10.33393/grhta.2023.2582

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Section

Original Research Articles

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Received 2023-03-22
Accepted 2023-05-17
Published 2023-06-26

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