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.

Downloads

Download data is not yet available.

References

Linee guida per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale ai sensi del d.m. 2 agosto 2019. Versione 1.0 - 2020. Online https://www.aifa.gov.it/documents/20142/1307543/2021.01.22_estratto_linee_guida_sezione_E.pdf (Accessed March 2023)

Ravasio R, Girolomoni G, Gorla R. Analisi di budget impact del biosimilare di etanercept: lo scenario italiano. Glob Reg Health Technol Assess. 2018;5:1-12. https://doi.org/10.33393/grhta.2018.444 DOI: https://doi.org/10.33393/abtpn.2019.280

Basile M, Somaini L, Cicchetti A. Analisi di Budget Impact della formulazione depot di buprenorfina a rilascio prolungato per la gestione di pazienti affetti da disturbo da uso di oppiacei. Glob Reg Health Technol Assess. 2021;8:96-104. https://doi.org/10.33393/grhta.2021.2237 DOI: https://doi.org/10.33393/grhta.2021.2237

Bini C, Mennini FS, Marcellusi A, Paoletti M, Tomino C. Analisi di impatto di budget di un nuovo sistema di cura in pazienti affetti da malattia di Parkinson. Glob Reg Health Technol Assess. 2022;9:91-98. https://doi.org/10.33393/grhta.2022.2413 DOI: https://doi.org/10.33393/grhta.2022.2413

Mauskopf JA, Sullivan SD, Annemans L, et al. Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices--budget impact analysis. Value Health. 2007;10(5):336-347. https://doi.org/10.1111/j.1524-4733.2007.00187.x PMID:17888098 DOI: https://doi.org/10.1111/j.1524-4733.2007.00187.x

Sullivan SD, Mauskopf JA, Augustovski F, et al. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force.

Value Health. 2014 Jan-Feb;17(1):5-14. https://doi.org/10.1016/j.jval.2013.08.2291 PMID:24438712 DOI: https://doi.org/10.1016/j.jval.2013.08.2291

Hasson F, Keeney S, McKenna H. Research guidelines for the Delphi survey technique. J Adv Nurs. 2000;32(4):1008-1015. PMID:11095242 DOI: https://doi.org/10.1046/j.1365-2648.2000.t01-1-01567.x

Giannarou L, Zervas E. Using Delphi technique to build consensus in practice. Int J Bus Sci Appl Manag. 2014;9:65-82.

Mauskopf J. Stephanie R. Earnshaw, Anita Brogan, Sorrel Wolowacz, Thor-Henrik Brodtkorb. Budget-Impact Analysis of Health Care Interventions. A Practical Guide. Springer International Publishing AG; 2017, https://doi.org/10.1007/978-3-319-50482-7. DOI: https://doi.org/10.1007/978-3-319-50482-7

Tastle WJ, Wierman MJ, Dumdum UR. Ranking ordinal scales using the consensus measure. Issues Inf Syst. 2005;6(2):96-102.

Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs--same or different? Value Health. 2009;12(4):402-404. https://doi.org/10.1111/j.1524-4733.2008.00476_1.x PMID:19138306 DOI: https://doi.org/10.1111/j.1524-4733.2008.00476_1.x

Taylor RS, Iglesias CP. Assessing the clinical and cost-effectiveness of medical devices and drugs: are they that different? Value Health. 2009;12(4):404-406. PMID:19138305 https://doi.org/10.1111/j.1524-4733.2008.00476_2.x PMID:19138305 DOI: https://doi.org/10.1111/j.1524-4733.2008.00476_2.x

Tarricone R, Callea G, Ogorevc M, Prevolnik Rupel V. Improving the Methods for the Economic Evaluation of Medical Devices. Health Econ. 2017;26(suppl 1):70-92. PMID:28139085 https://doi.org/10.1002/hec.3471 PMID:28139085 DOI: https://doi.org/10.1002/hec.3471

Gazzetta Ufficiale della Repubblica Italiana. Serie Generale n. 300 del 23.12.1996. Online https://www.gazzettaufficiale.it/eli/gu/1996/12/23/300/sg/pdf (Accessed March 2023)

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

Issue

Section

Original Research Articles

Categories

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

Metrics

Most read articles by the same author(s)

1 2 3 > >>