CRITICAL ANALYSIS OF THE HISTORY AND IMPACT OF COST-EFFECTIVENESS THRESHOLDS: LESSONS AND INSIGHTS FOR DECISION-MAKERS
Author(s)
Michael Schlander, MBA, PhD, MD1, Ramon Schaefer, BSc, MA, PhD1, Stacey Hickson, PhD2, Danielle Rollmann, MPA3, Christoph Glaetzer, Dipl. Kfm.3.
1Institute for Innovation & Valuation in Health Care (InnoValHC), Heidelberg, Germany, 2Senior Director, Global Access Policy, Johnson & Johnson, Raritan, NJ, USA, 3Johnson & Johnson, Raritan, NJ, USA.
1Institute for Innovation & Valuation in Health Care (InnoValHC), Heidelberg, Germany, 2Senior Director, Global Access Policy, Johnson & Johnson, Raritan, NJ, USA, 3Johnson & Johnson, Raritan, NJ, USA.
OBJECTIVES: Conduct a critical analysis of the conceptual basis of, and pragmatic experience with, cost-effectiveness thresholds (CETs) in healthcare policy and decision-making, their roles, limitations and open issues.
METHODS: An integrative review and ‘snowballing’ approach across textbooks, databases, grey literature, and seminal papers is being conducted. Of 3,586 records initially identified, 154 theoretical, 198 empirical, and 47 policy-related papers were considered eligible and included.
RESULTS: Analysis from this ongoing research uncovered at least six dominant themes: 1. Historical CET experiments: Some systems have chosen to leverage CETs; others have chosen not to, either based on principled reasoning and/or their perception of limited utility of CETs as a prioritization tool. 2. Establishing a CET: There is no uncontroversial scientific basis for the determination of any level of CET. Thresholds have been assigned differently across markets, contingent on the theoretical approach, local preferences, and political & technocratic pressures. 3. Ethical considerations: CETs drive equality of QALYs, but do not treat patients as persons equally. Social preferences and the social (distributive) goals of collectively financed health schemes beyond allocative efficiency defined in terms of health maximization are not addressed. 4. Usefulness in decision-making: CETs do not account for rights/based reasoning, and derived priorities inherent in constitutional provisions across nations. 5. Empirical issues: Apart from measurement challenges, CETs are by definition blind to budget impact. 6. Real-world implications: CETs can lead to delayed or reduced access to effective medicines meeting medical needs, resulting in ‘modifications’ to funding and access pathways and threshold levels to address social needs and preferences.
CONCLUSIONS: Cost-effectiveness thresholds raise fundamental ethical and methodological issues, as well as pragmatic questions on impact and the social dimensions of healthcare. Given the potentially far-reaching consequences for both patients and payers of selecting and utilizing an ill-defined CET, these issues should be openly discussed in each health system.
METHODS: An integrative review and ‘snowballing’ approach across textbooks, databases, grey literature, and seminal papers is being conducted. Of 3,586 records initially identified, 154 theoretical, 198 empirical, and 47 policy-related papers were considered eligible and included.
RESULTS: Analysis from this ongoing research uncovered at least six dominant themes: 1. Historical CET experiments: Some systems have chosen to leverage CETs; others have chosen not to, either based on principled reasoning and/or their perception of limited utility of CETs as a prioritization tool. 2. Establishing a CET: There is no uncontroversial scientific basis for the determination of any level of CET. Thresholds have been assigned differently across markets, contingent on the theoretical approach, local preferences, and political & technocratic pressures. 3. Ethical considerations: CETs drive equality of QALYs, but do not treat patients as persons equally. Social preferences and the social (distributive) goals of collectively financed health schemes beyond allocative efficiency defined in terms of health maximization are not addressed. 4. Usefulness in decision-making: CETs do not account for rights/based reasoning, and derived priorities inherent in constitutional provisions across nations. 5. Empirical issues: Apart from measurement challenges, CETs are by definition blind to budget impact. 6. Real-world implications: CETs can lead to delayed or reduced access to effective medicines meeting medical needs, resulting in ‘modifications’ to funding and access pathways and threshold levels to address social needs and preferences.
CONCLUSIONS: Cost-effectiveness thresholds raise fundamental ethical and methodological issues, as well as pragmatic questions on impact and the social dimensions of healthcare. Given the potentially far-reaching consequences for both patients and payers of selecting and utilizing an ill-defined CET, these issues should be openly discussed in each health system.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
P53
Topic
Economic Evaluation, Health Technology Assessment
Topic Subcategory
Thresholds & Opportunity Cost
Disease
No Additional Disease & Conditions/Specialized Treatment Areas