A policy model to evaluate the benefits, risks and costs of warfarin pharmacogenomic testing
Abstract
Background In 2007, the US FDA added information about pharmacogenomics to the warfarin label based on the influence of the CYP2C9 and VKORC1 genes on anticoagulation-related outcomes. Payers will be facing increasing demand for coverage decisions regarding this technology, but the potential clinical and economic impacts of testing are not clear. Objective To develop a policy model to evaluate the potential outcomes of warfarin pharmacogenomic testing based on the most recently available data. Methods A decision-analytic Markov model was developed to assess the addition of genetic testing to anticoagulation clinic standard care for a hypothetical cohort of warfarin patients. The model was based on anticoagulation status (international normalized ratio), a common outcome measure in clinical trials that captures both the benefits and risks of warfarin therapy. Initial estimates of testing effects were derived from a recently completed randomized controlled trial (n = 200). Healthcare cost ($US, year 2007 values) and health-state utility data were obtained from the literature. The perspective was that of a US third-party payer. Probabilistic and one-way sensitivity analyses were performed to explore the range of plausible results. Results The policy model included thromboembolic events (TEs) and bleeding events and was populated by data from the COUMAGEN trial. The rate of bleeding calculated for standard care approximated bleeding rates found in an independent cohort of warfari…
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STMs used to evaluate screening strategies consider two types: one-time screening or repeated interval screening.
“STMs used to evaluate screening strategies [16,17] consider two types: one-time screening, (e.g., of newborns [18] or genetic screening [19 -21]) or repeated (interval) screening (e.g., for cancer [22][23][24][25] or HIV [26,27]).”
From State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3 (2012) · cites this paper as [20]
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State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3
Siebert, U., Alagoz, O., Bayoumi, A. M., Jahn, B., Owens, D. K., Cohen, D. J., & Kuntz, K. M. (2012) · Value in Health · doi:10.1016/j.jval.2012.06.014 · Cited by 495 · see citing works
State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force–3
Siebert, U., Alagoz, O., Bayoumi, A. M., Jahn, B., Owens, D. K., Cohen, D. J., & Kuntz, K. M. (2012) · Medical Decision Making · doi:10.1177/0272989x12455463 · Cited by 348 · see citing works
Coleman, C. I., Limone, B. L., Bookhart, B. K., Mody, S. H., & Nutescu, E. A. (2014) · Thrombosis Research · doi:10.1016/j.thromres.2014.02.006 · Cited by 18 · see citing works
- Authors
- Meckley, L. M., Gudgeon, J. M., Anderson, J. L., Williams, M. S., & Veenstra, D. L.
- Affiliations
- University of Washington (US)
- Intermountain Healthcare (US)
- Corresponding author
- Veenstra, David L.
- Venue
- PharmacoEconomics
- Published
- 2010-01
- Volume
- 28
- Issue
- 1
- Pages
- 61-74
- ISSN
- 1170-7690 (ISSN-L)
- OpenAlex
- W2059533196
- Cited by
- 97
- References
- 0
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 1 · 2022: 3 · 2021: 4 · 2019: 1 · 2018: 3 · 2017: 10 · 2016: 4 · 2015: 10 · 2014: 8 · 2013: 16 · 2012: 16
- FWCI
- 10.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- PharmacoEconomics (publishedVersion)
- PubMed (publishedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- Funders
- University of Washington
- Centers for Disease Control and Prevention (1u18gd000005-01)
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Keywords
- warfarin, pharmacogenetic testing, CYP2C9, VKORC1, anticoagulation, cost-effectiveness, bleeding risk, thromboembolic events, international normalized ratio, genotyping cost, health technology assessment, quality-adjusted life years
- MeSH terms
- Anticoagulants, Aryl Hydrocarbon Hydroxylases, Cost-Benefit Analysis, Costs and Cost Analysis, Health Policy, Humans, Markov Chains, Pharmacogenetics, Genetic Variation, Warfarin, Models, Organizational, Quality-Adjusted Life Years, International Normalized Ratio, Cytochrome P-450 CYP2C9
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