Best Practices for the Development of Budget Impact Models at Regional Level
Author(s)
Marcellusi A1, Ragonese A2, Bortolami A3, Marinozzi A4, Mucherino S5, Moreno C6, Antenori A7, Attanasio F8, Cicoira M9, Donati C10, Ferrario M11, Lasala R12, Roni C13, Russoniello F14, Simonelli C15, Zanuzzi M16, Canonico PL17
1University of Rome “Tor Vergata”, Rome, Italy, 2Clinical Psychologist, roma, RM, Italy, 3Veneto Oncology Network, Veneto Institute of Oncology IRCCS, Padova, Italy, 4Hospital Pharmacist, Clinical Pharmacy, Department of Health Servis, AO University United Hospitals of Ancona, Ancona, Italy, 5Center of Pharmacoeconomics and Drug Utilization Research (CIRFF), Department of Pharmacy, University of Naples Federico II, Rome, RM, Italy, 6Value & Access Specialist, Regulatory Pharma Net, Pisa, Italy, 7Lead Pricing, Reimbursement & Access, Eli Lilly spa, Roma, RM, Italy, 8Drugs and appropriateness policy sector, Tuscan Regional Authority, Firenze, Italy, 9Pharmaceutical Department, ASP Trapani, Trapani, Italy, Trapani, Italy, 10Oncology Pharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy, 11Integrated Access Lead, Roche Spa, Monza, Italy, 12Local Health Unit of Bari, Bari, Italy, 13Central Directorate for Health, Social Policies and Disability, Pharmaceutical Assistance Service, Region Autonomous Friuli Venezia Giulia, Trieste, Italy, 14Pharmaceutical Department, ASL Napoli 1 Centro, Napoli, Italy, 15Study and Scientific Solutions, Medtronic Core Clinical Solutions, Rome, Italy, 16Italian Medicines Agency, Roma, Italy, 17University of Eastern Piedmont, Novara, Italy
OBJECTIVES: The present work aims to discuss the current scenario of procedures and regulations regarding budget impact analysis (BIA) models at regional level in Italy andprovide a standardized approach and detailed recommendations for developing a BIA
METHODS: A multidisciplinary scientific group were enrolled from Academia (1 researcher), Regulatory Agency (1 expert from AIFA), Regional Entities (10 pharmacists), Medical Device and Pharma Companies (3 access managers) and Healthcare Consultancy Firms (1 access lead). A systematic review of the literature was conducted in order to collect the main documents available about 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 possible solutions to anycritical issues
RESULTS: The ISPOR analytic framework was applied to all regions, and the results were narratively summarised and presented in evidence tables.The consensus process will allowto collect many experts' opinions on the main issues relating the best practices in BIA. All affiliated members of ISPOR Italy Rome chapter will complete the consensus questionnaire during Q4 2022.
CONCLUSIONS: While the structure and development of BIM are now well-known and well-applied at the national level, there remains a great diversity of management of BIM tools at the regional level. This project aims to develop a good practice tool to be applied in all Italian regions for the development of appropriate BIM analysis
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
HTA187
Topic
Economic Evaluation, Study Approaches
Topic Subcategory
Budget Impact Analysis, Literature Review & Synthesis, Surveys & Expert Panels
Disease
No Additional Disease & Conditions/Specialized Treatment Areas