Spain Leveling Up: A Comparison of Spain’s New National Health Economic Evaluation Guideline With Those of England, France, Germany, Italy, Portugal, Sweden, Ireland, Canada, Australia, and Japan
Author(s)
Ayesha Naz, MSc1, Patrycja Jaros, MSc, PharmD1, Clement Francois, MSc, PhD2, Yoshie Onishi, Dr.P.H., MSc3, Catriona Crossan, MSc4, Simon Pannett, MSc1.
1Putnam, London, United Kingdom, 2Putnam, Paris, France, 3Putnam, Tokyo, Japan, 4Putnam, Newcastle Upon Tyne, United Kingdom.
1Putnam, London, United Kingdom, 2Putnam, Paris, France, 3Putnam, Tokyo, Japan, 4Putnam, Newcastle Upon Tyne, United Kingdom.
OBJECTIVES: In March 2024, as part of broader pharmaceutical policy reforms, the Spanish Ministry of Health published its first national health economic evaluation (HEE) guideline. This study compares Spain’s new HEE guideline with those from ten countries across Europe, North America, and the Asia-Pacific region to determine the implications for manufacturers.
METHODS: Spain’s HEE guideline was reviewed alongside those of England, France, Germany, Italy, Portugal, Sweden, Ireland, Canada, Australia, and Japan. Key comparative elements included population and comparator selection, perspective, analytical approach, clinical and economic data requirements, utility measurement methods, time horizon, discounting, uncertainty analysis, equity considerations, and the role of HEE in decision-making. The comparison was informed by a previous analysis by Nomoto et al. (2023), updated through a targeted literature review.
RESULTS: Spain’s guideline shares many similarities with other countries, specifying that the evaluated population should reflect the authorised indication, with subgroup analysis required when heterogeneity may influence outcomes. Comparators must include standard practice as well as the most effective, most cost-effective, and lowest-priced alternatives. Like most countries using HEE for pricing and reimbursement decisions, Spain prioritises cost-utility analysis using indirect preference elicitation methods (EQ-5D, SF-6D), requires a healthcare payer perspective, and a time horizon sufficient to capture all relevant outcomes. A notable distinction is Spain’s explicit requirement for external model validation, which is mostly discretionary elsewhere. There are recommendations to prioritise HEE for medicines demonstrating substantial additional clinical benefit; however, its exact role in decision-making has not yet been formalised.
CONCLUSIONS: Spain’s guideline broadly aligns with international standards and marks a significant step in formally integrating HEE into pharmaceutical decision-making. While it remains to be seen whether its publication signals a shift toward greater importance of HEE relative to budget impact analysis, it signals a shift toward a more rigorous, value-based environment, challenging therapies with marginal benefit.
METHODS: Spain’s HEE guideline was reviewed alongside those of England, France, Germany, Italy, Portugal, Sweden, Ireland, Canada, Australia, and Japan. Key comparative elements included population and comparator selection, perspective, analytical approach, clinical and economic data requirements, utility measurement methods, time horizon, discounting, uncertainty analysis, equity considerations, and the role of HEE in decision-making. The comparison was informed by a previous analysis by Nomoto et al. (2023), updated through a targeted literature review.
RESULTS: Spain’s guideline shares many similarities with other countries, specifying that the evaluated population should reflect the authorised indication, with subgroup analysis required when heterogeneity may influence outcomes. Comparators must include standard practice as well as the most effective, most cost-effective, and lowest-priced alternatives. Like most countries using HEE for pricing and reimbursement decisions, Spain prioritises cost-utility analysis using indirect preference elicitation methods (EQ-5D, SF-6D), requires a healthcare payer perspective, and a time horizon sufficient to capture all relevant outcomes. A notable distinction is Spain’s explicit requirement for external model validation, which is mostly discretionary elsewhere. There are recommendations to prioritise HEE for medicines demonstrating substantial additional clinical benefit; however, its exact role in decision-making has not yet been formalised.
CONCLUSIONS: Spain’s guideline broadly aligns with international standards and marks a significant step in formally integrating HEE into pharmaceutical decision-making. While it remains to be seen whether its publication signals a shift toward greater importance of HEE relative to budget impact analysis, it signals a shift toward a more rigorous, value-based environment, challenging therapies with marginal benefit.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE668
Topic
Economic Evaluation
Disease
No Additional Disease & Conditions/Specialized Treatment Areas