Presentation (CTI)

OBJECTIVES: Cost-effectiveness thresholds (CETs) are a key element of Health Technology Assessment (HTA), supporting evidence-based decisions in pricing and reimbursement. While several countries, including the United Kingdom (£20,000-30,000 per QALY) and Canada (CAD$50,000 per QALY), have adopted formal CETs, Italy still lacks an explicit threshold, despite the increasing reliance on economic evaluations. This study aims to compare international CET approaches and assess their relevance for shaping a structured threshold framework in Italy.
METHODS: A sistematic literature review was conducted to identify CET values, definition methods, and the use of modifiers across 27 countries. Sources included HTA agency guidelines, peer-reviewed literature, and institutional reports. Special focus was given to the role of contextual modifiers such as disease severity, rarity, and end-of-life status.
RESULTS: The analysis revealed considerable heterogeneity. Some countries use fixed CETs, while others apply formal modifiers. The Netherlands adopts a proportional shortfall approach to reflect disease burden; Norway stratifies CETs based on absolute QALY loss; and England’s Highly Specialised Technologies programme permits thresholds up to £300,000 per QALY for ultra-rare diseases. In Italy, recent studies suggest an implicit CET of €33,004 per QALY, with limited increases for orphan indications (€37,157) and severe conditions (€41,411). These values are substantially lower than international comparators. Based on global models, adopting structured multipliers—1.2-1.7 for severity, and 3-10 for rarity—could provide a pragmatic solution.
CONCLUSIONS: Italy may benefit from a transparent and flexible CET framework that incorporates clinical and contextual factors. Such an approach could enhance fairness, predictability, and alignment with international best practices in reimbursement decision-making.