Multicriteria and economic evaluations: toward a proposal for a new framework for drug pricing in Italy

Introduction: The drug pricing and reimbursement process in Italy lacks a structured and shared framework to translate therapeutic value into consistent economic criteria, especially in a regulatory context characterized by spending caps and increasing pressure on access to innovations. The present work proposes a valuation model capable of combining methodological rigor and operational flexibility. Methods: A qualitative analysis was conducted based on the activities of the multidisciplinary Working Group, which compared international models (e.g., cost-effectiveness vs. multicriteria) to outline a pragmatic framework, adaptable to the Italian context. The framework validation was done through SWOT-analysis. Results: The framework is characterized by a modular structure, integrating clinical, economic and organizational components. The cost-effectiveness model was indicated as preferred to ensure consistency and transparency, while multicriteria remains useful in complex cases. The framework adapts to special contexts (e.g., orphan drugs) by providing more flexibility in ICER thresholds and the use of price-volume trade-off logic. The SWOT-analysis revealed strengths in the clear and shared nature of the rules and in reducing the risk of discretion; weaknesses include difficulty in defining thresholds and interpreting exceptions. Opportunities are in stakeholder involvement and in the possibility of faster and more standardized reporting. Major threats are related to limitations in technical expertise and possible resistance to accepting rules in exceptional cases. Conclusions: The proposed model represents a step toward a structured assessment of the value of medicines in Italy. Its adoption may promote equity, efficiency and sustainability, although requiring systemic and regulatory investment to ensure its viability.