CHALLENGES FOR THE ECONOMIC EVALUATION OF DIAGNOSTIC TECHNOLOGIES: A REVIEW AND TAXONOMY
Author(s)
Osvaldo Ulises Garay, BEc, MSc1, Simon Walker, MSc2, Ankur Pandya, MPH, PhD3, Federico Augustovski, MSc, PhD, MD4, Tristan Snowsill, PhD5, Paul Tappenden, BA, MSc, PhD6, Martin Vu, BSc, MPH, PhD7, Stephen Palmer, MSc, PhD8, Marta Ferreira Oliveira Soares, PhD2.
1Access Evidence Generation, Roche Diagnostics International, Rotkreuz, Switzerland, 2University of York, York, United Kingdom, 3Harvard T.H. Chan School of Public Health, Boston, MA, USA, 4Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina, 5University of Exeter Medical School, Exeter, United Kingdom, 6ScHARR, University of Sheffield, Sheffield, United Kingdom, 7Queen Mary University of London, BOW, United Kingdom, 8University of York, YORK, United Kingdom.
1Access Evidence Generation, Roche Diagnostics International, Rotkreuz, Switzerland, 2University of York, York, United Kingdom, 3Harvard T.H. Chan School of Public Health, Boston, MA, USA, 4Institute for Clinical Effectiveness and Health Policy, Buenos Aires, Argentina, 5University of Exeter Medical School, Exeter, United Kingdom, 6ScHARR, University of Sheffield, Sheffield, United Kingdom, 7Queen Mary University of London, BOW, United Kingdom, 8University of York, YORK, United Kingdom.
OBJECTIVES: Diagnostic technologies present challenges for economic evaluation. Understanding these challenges is crucial for objective and robust assessments. This research aimed to identify and categorise methodological and other challenges for the economic evaluation of diagnostic technologies based on a review of the published literature and consultation with experts in the field.
METHODS: A pragmatic literature review was conducted to identify economic evaluations and methodological studies on diagnostics mentioning challenges. These challenges were extracted, thematically consolidated to remove redundancies, and classified into a draft taxonomy. This framework was then extended and refined through feedback from 13 international experts from academia, industry, and HTA bodies.
RESULTS: The literature review identified 761 relevant studies of which 29 were selected for data extraction. A total of 137 challenge descriptions were extracted and, after expert consultation, consolidated into 40 distinct challenges. The taxonomy classified challenges into three main categories: Evidence Generation, which includes Direct Evidence (tracking the journey of individuals from test to outcome) and Linked Evidence (modelling outcomes via multiple sources); Ethical and Normative; and Others.
CONCLUSIONS: This project provides a comprehensive list and novel taxonomy of challenges for the economic evaluation of diagnostic technologies. This can serve as a strategic tool to optimise early-stage test development and evidence planning, and help researchers and HTA bodies anticipate methodological pitfalls. By identifying these challenges upfront, the framework ensures that critical complexities are not overlooked during evaluation, allows stakeholders to determine methodological solutions where available, and highlights gaps that require the development and funding of new research to improve the robustness of diagnostic value assessments.
METHODS: A pragmatic literature review was conducted to identify economic evaluations and methodological studies on diagnostics mentioning challenges. These challenges were extracted, thematically consolidated to remove redundancies, and classified into a draft taxonomy. This framework was then extended and refined through feedback from 13 international experts from academia, industry, and HTA bodies.
RESULTS: The literature review identified 761 relevant studies of which 29 were selected for data extraction. A total of 137 challenge descriptions were extracted and, after expert consultation, consolidated into 40 distinct challenges. The taxonomy classified challenges into three main categories: Evidence Generation, which includes Direct Evidence (tracking the journey of individuals from test to outcome) and Linked Evidence (modelling outcomes via multiple sources); Ethical and Normative; and Others.
CONCLUSIONS: This project provides a comprehensive list and novel taxonomy of challenges for the economic evaluation of diagnostic technologies. This can serve as a strategic tool to optimise early-stage test development and evidence planning, and help researchers and HTA bodies anticipate methodological pitfalls. By identifying these challenges upfront, the framework ensures that critical complexities are not overlooked during evaluation, allows stakeholders to determine methodological solutions where available, and highlights gaps that require the development and funding of new research to improve the robustness of diagnostic value assessments.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
MSR291
Topic
Health Technology Assessment, Medical Technologies, Methodological & Statistical Research
Disease
No Additional Disease & Conditions/Specialized Treatment Areas