Management and utilization of the Fund for Innovative Medicines: a multistakeholder qualitative survey on regional and local practices
DOI:
https://doi.org/10.33393/grhta.2025.3433Keywords:
Financial management, Funds, Innovative medicines, Italy, Organizational models, Pharmaceutical policyAbstract
Introduction: The Fund for Innovative Medicines, Fondo Farmaci Innovativi (FFI), enables financing, non-competition, and fast access to innovative medicines. However, limited evidence exists regarding its management processes and the stakeholders involved. In order to identify characteristics, critical issues, and improvement opportunities, this analysis investigates the FFI management processes through the perspective of the Key Opinion Leaders (KOLs) involved.
Methods: The research employs a qualitative research methodology. A survey administered through interviews to 18 KOLs (clinicians, hospital pharmacists, top hospital managers, and regional pharmaceutical service directors) from 9 Italian regions provided evidence of FFI utilization patterns. The content analysis identified FFI management features, challenges, and best practices. The expert meeting discussion validated the findings and developed consensus priority recommendations.
Results: The FFI regulation promotes the convergence between regional and local authorities; however, different regional governance models may determine varying levels of organizational efficiency. Critical interventions were proposed: overall, enhanced AIFA data feedback is supported by 85% of the sample; regionally, strengthened communication with local institutions and centralized planning are recommended (mean score 3.2/4); locally, enhanced digitalization of reporting systems may address operational inefficiencies for clinicians and hospital pharmacists (mean score 3.4/4).
Conclusion: This analysis contributed to a better awareness of the current FFI management process through a multi-level and multi-professional methodology. Partial return of data, potential distortions of a fund’s allocation based on usage, multiplication of accounting processes, and regional variability in healthcare governance provide a foundation for targeted improvement interventions and to direct future research.
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References
AIFA. Farmaci Innovativi. Online https://www.aifa.gov.it/farmaci-innovativi (Accessed November 2024)
Jommi C, Armeni P, Bertolani A, Costa F, Otto M. Il futuro dei Fondi per Farmaci Innovativi: risultati di uno studio basato su Delphi panel. Glob Reg Health Technol Assess. 2021;8:22-28. https://doi.org/10.33393/grhta.2021.2219 PMID:36627867 DOI: https://doi.org/10.33393/grhta.2021.2219
Gazzetta Ufficiale della Repubblica Italiana. Legge 11 dicembre 2016, n. 232. Online https://www.gazzettaufficiale.it/eli/id/2016/12/21/16G00242/sg (Accessed November 2024)
Gazzetta Ufficiale della Repubblica Italiana. Decreto-Legge 25 maggio 2021, n. 73. Online https://www.gazzettaufficiale.it/atto/vediMenuHTML?atto.dataPubblicazioneGazzetta=2021-05-25&atto.codiceRedazionale=21G00084&tipoSerie=serie_generale&tipoVigenza=originario
(Accessed November 2024)
Gazzetta Ufficiale della Repubblica Italiana. Legge 30 dicembre 2021, n. 234. Online https://www.gazzettaufficiale.it/atto/vediMenuHTML?atto.dataPubblicazioneGazzetta=2021-12-31&atto.codiceRedazionale=21G00256&tipoSerie=serie_generale&tipoVigenza=originario (Accessed November 2024)
Gazzetta Ufficiale della Repubblica Italiana. Decreto 16 febbraio 2018. Online https://www.camera.it/temiap/2018/12/06/OCD177-3842.pdf (Accessed November 2024)
AIFA. Monitoraggio della Spesa Farmaceutica Nazionale e Regionale Gennaio-Dicembre 2023 Consuntivo. Online https://www.aifa.gov.it/documents/20142/1872190/Monitoraggio_Spesa_gennaio-dicembre-2023_consultivo.pdf (Accessed November 2024)
Squillace A, Nardi S. Indagine civica sul grado di accesso ai farmaci innovativi. Cittadinanzattiva. Online https://www.cittadinanzattiva.it/multimedia/import/files/primo_piano/salute/INDAGINE-CIVICA-SUL-GRADO-DI-ACCESSO-AI-FARMACI-INNOVATIVI.pdf (Accessed November 2024)
Davies EL, Bulto LN, Walsh A, et al. Reporting and conducting patient journey mapping research in healthcare: A scoping review. J Adv Nurs. 2023;79(1):83-100. https://doi.org/10.1111/jan.15479 PMID:36330555 DOI: https://doi.org/10.1111/jan.15479
Busetto L, Wick W, Gumbinger C. How to use and assess qualitative research methods. Neurol Res Pract. 2020;2(1):14. https://doi.org/10.1186/s42466-020-00059-z PMID:33324920 DOI: https://doi.org/10.1186/s42466-020-00059-z
Martini M. Il benchmarking in Sanità Pubblica. Leadership Medica. 2001; 9:22. Available at (online): https://www.leadershipmedica.it/index.php/p-z/politica-sanitaria/368-il-benchmarking-in-sanita-pubblica (Accessed November 2024)
Cicchetti DV, Shoinralter D, Tyrer PJ. The Effect of Number of Rating Scale Categories on Levels of Interrater Reliability: A Monte Carlo Investigation. Appl Psychol Meas. 1985;9(1):31-36. https://doi.org/10.1177/014662168500900103 DOI: https://doi.org/10.1177/014662168500900103
York Health Economics Consortium. Rating Scale (2016). Online https://yhec.co.uk/glossary/rating-scale (Accessed November 2024)
Camera dei deputati del Parlamento Italiano. Legge di Bilancio 2025 – Provvedimento 8 novembre 2024. Online https://temi.camera.it/leg19/provvedimento/la-legge-di-bilancio-per-il-2025.html (Accessed November 2024)
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Accepted 2025-03-05
Published 2025-03-27