OBJECTIVES: The present work aims to discuss the role of the economic evaluation in the new guidelines for pricing and reimbursement (P&R) of medicines adopted by the Italian Medicines Agency (AIFA) in March 2021.

METHODS: A multidisciplinary scientific group were enrolled from Academia (2 researchers), Regulatory Agency (1 expert from AIFA), Regional Entities (2 pharmacists), Pharma Companies (2 access managers) and Healthcare Consultancy Firms (2 access leads). A systematic review of the literature was conducted in order to collect the main documents available in Europe about the role of economic evaluations in the P&R process. All the records were analysed in qualitative terms according to a pre-specified analytical framework. At the end of the analysis, a consensus questionnaire was developed to establish agreed approaches and possible solutions to any critical issues.

RESULTS: A common analysis framework was applied to all countries, and the results were narratively summarised and presented in evidence tables. The consensus process allowed to collect many experts' opinions on the main issues relating to P&R approaches. All affiliated members of ISPOR Italy Rome chapter will complete the consensus questionnaire during Q4 2021.

CONCLUSION: The new AIFA guidelines provide an opportunity to improve the use of economic evaluations. Comparison with the guidelines used in other European countries demonstrates the importance of a standardised and transparent approach to economic analysis in healthcare for improving transparency of the economic modelling approach during the P&R process.