Technical Validation of Health Economic Models: Is There a Gold Standard? Assessment and Refinement of Current Checklist Tools
Author(s)
Anna Tokarz, MSc1, Agota Szende, PhD2, Emilija Veljanoska, MSc3.
1Market Access Consulting & HEOR, Fortrea, Warsaw, Poland, 2Market Access Consulting & HEOR, Fortrea, Leeds, United Kingdom, 3Fortrea, Munich, Germany.
1Market Access Consulting & HEOR, Fortrea, Warsaw, Poland, 2Market Access Consulting & HEOR, Fortrea, Leeds, United Kingdom, 3Fortrea, Munich, Germany.
OBJECTIVES: Model validation is essential in cost-effectiveness (CE) evaluations of new therapies. While internal, external, and cross-validation are standard approaches to assess credibility, tools for verifying the technical correctness of model calculations remain limited. We reviewed existing checklists and developed an enhanced technical checklist to address observed methodological gaps.
METHODS: We conducted a structured review using PubMed and AI-assisted searches to identify validation checklists applied in economic models. Checklists were classified into four domains: technical (T), methodological (M), reporting (R), and country-specific (C). Country-specific HTA guidelines were excluded due to their focus on M and R aspects. A framework of 19 validation test categories was used for comparison.
RESULTS: Of 42 identified publications, 12 were excluded as country-specific HTA guidelines, leaving 30 for analysis. Most (n=22) emphasized reporting or methodology; only 8 addressed technical aspects. Only one included tests for calculation verification, sensitivity, and credibility organised across four modules. None assessed data flow, model adaptation, efficiency, or volatile functions. To address these gaps, we developed a complementary set of verification tests and combined them with existing checklists. By synthesizing the 8 relevant checklists, 5 new items were added to the existing 4 modules. We also introduced 3 new modules for model adaptation and validity, Visual Basic for Applications (VBA), and budget impact models (BIM). In total, 14 new items were added to the existing modules and 23 to the new ones. Key additions include assessments of model flow, volatile functions, validity, and VBA/BIM-specific tests. The final checklist includes 7 modules and 130 tests, each with a defined expected outcome.
CONCLUSIONS: Current validation tools mainly emphasize methodological and reporting standards, offering limited technical assurance. Our expanded checklist addresses this gap, which might help to ensure higher technical accuracy of CE models and support more reliable reimbursement decisions.
METHODS: We conducted a structured review using PubMed and AI-assisted searches to identify validation checklists applied in economic models. Checklists were classified into four domains: technical (T), methodological (M), reporting (R), and country-specific (C). Country-specific HTA guidelines were excluded due to their focus on M and R aspects. A framework of 19 validation test categories was used for comparison.
RESULTS: Of 42 identified publications, 12 were excluded as country-specific HTA guidelines, leaving 30 for analysis. Most (n=22) emphasized reporting or methodology; only 8 addressed technical aspects. Only one included tests for calculation verification, sensitivity, and credibility organised across four modules. None assessed data flow, model adaptation, efficiency, or volatile functions. To address these gaps, we developed a complementary set of verification tests and combined them with existing checklists. By synthesizing the 8 relevant checklists, 5 new items were added to the existing 4 modules. We also introduced 3 new modules for model adaptation and validity, Visual Basic for Applications (VBA), and budget impact models (BIM). In total, 14 new items were added to the existing modules and 23 to the new ones. Key additions include assessments of model flow, volatile functions, validity, and VBA/BIM-specific tests. The final checklist includes 7 modules and 130 tests, each with a defined expected outcome.
CONCLUSIONS: Current validation tools mainly emphasize methodological and reporting standards, offering limited technical assurance. Our expanded checklist addresses this gap, which might help to ensure higher technical accuracy of CE models and support more reliable reimbursement decisions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE684
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas