How Cost-Effectiveness and Budget Impact Drive Pricing and Reimbursement: Insights From an International Comparative Study
Author(s)
Camille SEGUIER, PharmD1, Claire ARFI, PharmD1, Clément Le Dissez, PharmD1, Sandrine Bourguignon, MSc, PhD2, Raphaël TOUEG, MSc3, Alice SELINGER, PharmD3, Laurent Petit, PharmD3, Elsa Duteil, MSc1.
1PASS, Paris, France, 2RWEality, BONDOUFLE, France, 3Leem, Paris, France.
1PASS, Paris, France, 2RWEality, BONDOUFLE, France, 3Leem, Paris, France.
OBJECTIVES: This study aims to comparatively analyze how cost-effectiveness (CEA) and budget impact analyses (BIA) are used and influence reimbursement and pricing decisions across diverses healthcare systems.
METHODS: The study covers 11 countries with diverse healthcare systems, including France, the UK, Germany, Italy, Sweden and the Netherlands. A pragmatic review of grey literature, official guidelines, and HTA agency websites was conducted to collect comparative data on CEA and BIA assessment.
RESULTS: Responsibilities for evaluation and pricing differ across countries, ranging from centralized agencies to decentralized systems at the regional level. Among the 10 countries included in the study (the United States was excluded, as CEA is optional for private payers), 80% incorporate CEA in reimbursement decisions and all in pricing decisions. In 80% of cases, it is the primary decision-making criterion. And only 30% of countries integrate BIA into reimbursement decisions. In each of the countries analyzed, CEA and BIA may influence decision-making either directly or indirectly. For all countries that consider CEA or BIA in reimbursement decisions, the influence is direct. Regarding pricing decisions, CEA has a direct impact in 38% of the countries concerned, and an indirect impact in 62%. As for BIA, it directly or uncertainly influences pricing in 38% of cases and has no impact in 25% of cases. Three main system profiles emerged: (1) countries prioritizing therapeutic added value compared to existing treatments (e.g., France); (2) those relying on cost-effectiveness threshold (e.g., the UK) or reference value (e.g., the Netherlands); and (3) those where budget impact dominates decision-making (e.g., Italy).
CONCLUSIONS: In conclusion, CEA is a key driver of reimbursement and pricing decisions, although its role varies across countries. BIA remains secondary and exerts influence when substantial cost savings are demonstrated. Finally, this study highlights the lack of a harmonized international framework.
METHODS: The study covers 11 countries with diverse healthcare systems, including France, the UK, Germany, Italy, Sweden and the Netherlands. A pragmatic review of grey literature, official guidelines, and HTA agency websites was conducted to collect comparative data on CEA and BIA assessment.
RESULTS: Responsibilities for evaluation and pricing differ across countries, ranging from centralized agencies to decentralized systems at the regional level. Among the 10 countries included in the study (the United States was excluded, as CEA is optional for private payers), 80% incorporate CEA in reimbursement decisions and all in pricing decisions. In 80% of cases, it is the primary decision-making criterion. And only 30% of countries integrate BIA into reimbursement decisions. In each of the countries analyzed, CEA and BIA may influence decision-making either directly or indirectly. For all countries that consider CEA or BIA in reimbursement decisions, the influence is direct. Regarding pricing decisions, CEA has a direct impact in 38% of the countries concerned, and an indirect impact in 62%. As for BIA, it directly or uncertainly influences pricing in 38% of cases and has no impact in 25% of cases. Three main system profiles emerged: (1) countries prioritizing therapeutic added value compared to existing treatments (e.g., France); (2) those relying on cost-effectiveness threshold (e.g., the UK) or reference value (e.g., the Netherlands); and (3) those where budget impact dominates decision-making (e.g., Italy).
CONCLUSIONS: In conclusion, CEA is a key driver of reimbursement and pricing decisions, although its role varies across countries. BIA remains secondary and exerts influence when substantial cost savings are demonstrated. Finally, this study highlights the lack of a harmonized international framework.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE521
Topic
Economic Evaluation, Health Technology Assessment
Topic Subcategory
Thresholds & Opportunity Cost, Value of Information
Disease
No Additional Disease & Conditions/Specialized Treatment Areas