Susan R Snyder1, Jing Hao2, Larisa H Cavallari3, Zhi Geng2, Amanda Elsey3, Julie A Johnson3, Zahurin Mohamed4, Nathorn Chaiyakunapruk5,6,7,8,9, Huey Yi Chong5, Maznah Dahlui10, Fatiha H Shabaruddin11, George P Patrinos12,13, Christina Mitropoulou14, Marc S Williams15. 1. Department of Epidemiology and Health Services Research, Geisinger Health System, Danville, Pennsylvania, USA, ssnyder@gsu.edu. 2. Department of Epidemiology and Health Services Research, Geisinger Health System, Danville, Pennsylvania, USA. 3. Department of Pharmacotherapy and Translational Research, University of Florida, Gainesville, Florida, USA. 4. Department of Pharmacology, University of Malaya, Kuala Lumpur, Malaysia. 5. School of Pharmacy, Monash University Sunway Campus, Subang Jaya, Malaysia. 6. Center of Pharmaceutical Outcomes Research (CPOR), Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand. 7. School of Pharmacy, University of Wisconsin, Madison, Wisconsin, USA. 8. Asian Centre for Evidence Synthesis in Population, Implementation and Clinical Outcomes (PICO), Global Asia in the 21st Century (GA21) Platform, Monash University, Subang Jaya, Malaysia. 9. Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, Utah, USA. 10. Department of Social and Preventive Medicine, Julius Centre, University of Malaya, Kuala Lumpur, Malaysia. 11. Department of Pharmacy, University of Malaya, Kuala Lumpur, Malaysia. 12. University of Patras School of Health Sciences Department of Pharmacy, Patras, Greece. 13. United Arab Emirates University, College of Medicine, Department of Pathology, Al-Ain, United Arab Emirates. 14. The Golden Helix Foundation, London, United Kingdom. 15. Genomic Medicine Institute, Geisinger Health System, Danville, Pennsylvania, USA.
Abstract
BACKGROUND/AIMS: Economic evaluation is integral to informed public health decision-making in the rapidly growing field of precision and personalized medicine (PM); however, this research requires specialized expertise and significant resources. Generic models are a novel innovation to efficiently address a critical PM evidence shortage and implementation barrier by enabling use of population-specific input values. This is a generic PM economic evaluation model proof-of-concept study for a pharmacogenomic use case. METHODS: An 8-step generic economic model development process was applied to the use case of human leukocyte antigen (HLA)-B*15:02genotyping for prediction of carbamazepine-induced cutaneous reactions, with a user-friendly decision-making tool relying on user-provided input values. This generic model was transparently documented and validated, including cross-validation comparing cost-effectiveness results with 3 country-specific models. RESULTS: A generic pharmacogenomic use case cost-effectiveness model with decision-making tool was successfully developed and cross-validated using input values for 6 populations which produced consistent results for HLA-B*15:02 screening at country-specific cost-effectiveness threshold values. Differences between the generic and country-specific model results were largely due to differences in model structure and assumptions. CONCLUSION: This proof on concept demonstrates the feasibility of generic models to provide useful PM economic evidence, supporting their use as a pragmatic and timely approach to address a growing need.
BACKGROUND/AIMS: Economic evaluation is integral to informed public health decision-making in the rapidly growing field of precision and personalized medicine (PM); however, this research requires specialized expertise and significant resources. Generic models are a novel innovation to efficiently address a critical PM evidence shortage and implementation barrier by enabling use of population-specific input values. This is a generic PM economic evaluation model proof-of-concept study for a pharmacogenomic use case. METHODS: An 8-step generic economic model development process was applied to the use case of humanleukocyte antigen (HLA)-B*15:02genotyping for prediction of carbamazepine-induced cutaneous reactions, with a user-friendly decision-making tool relying on user-provided input values. This generic model was transparently documented and validated, including cross-validation comparing cost-effectiveness results with 3 country-specific models. RESULTS: A generic pharmacogenomic use case cost-effectiveness model with decision-making tool was successfully developed and cross-validated using input values for 6 populations which produced consistent results for HLA-B*15:02 screening at country-specific cost-effectiveness threshold values. Differences between the generic and country-specific model results were largely due to differences in model structure and assumptions. CONCLUSION: This proof on concept demonstrates the feasibility of generic models to provide useful PM economic evidence, supporting their use as a pragmatic and timely approach to address a growing need.
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