title: Cost-utility analysis of genotype-guided antiplatelet therapy in patients with moderate-to-high risk acute coronary syndrome and planned percutaneous coronary intervention.
abstract: BACKGROUND
  Prasugrel is recommended over clopidogrel in poor/intermediate CYP2C19 metabolizers with acute coronary syndrome (ACS) and planned percutaneous coronary intervention (PCI), reducing the risk of ischemic events. CYP2C19 genetic testing can guide antiplatelet therapy in ACS patients.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate the cost-utility of genotype-guided treatment, compared with prasugrel or generic clopidogrel treatment without genotyping, from the US healthcare provider's perspective.
  
  
  METHODS
  A decision model was developed to project lifetime economic and humanistic burden associated with clinical outcomes (myocardial infarction [MI], stroke and major bleeding) for the three strategies in patients with ACS. Probabilities, costs and age-adjusted quality of life were identified through systematic literature review. Incremental cost-utility ratios (ICURs) were calculated for the treatment strategies, with quality-adjusted life years (QALYs) as the primary effectiveness outcome. Relative risk of developing myocardial infarction and stroke between patients with and without variant CYP2C19 when receiving clopidogrel were estimated to be 1.34 and 3.66, respectively. One-way and probabilistic sensitivity analyses were performed.
  
  
  RESULTS
  Clopidogrel cost USD19,147 and provided 10.03 QALYs versus prasugrel (USD21,425, 10.04 QALYs) and genotype-guided therapy (USD19,231, 10.05 QALYs). The ICUR of genotype-guided therapy compared with clopidogrel was USD4,200. Genotype-guided therapy provided more QALYs at lower costs compared with prasugrel. Results were sensitive to the cost of clopidogrel and relative risk of myocardial infarction and stroke between CYP2C19 variant vs. non-variant. Net monetary benefit curves showed that genotype-guided therapy had at least 70% likelihood of being the most cost-effective alternative at a willingness-to-pay of USD100,000/QALY. In comparison with clopidogrel, prasugrel therapy was more cost-effective with <21% certainty at willingness-to-pay of >USD170,000/QALY.
  
  
  CONCLUSIONS
  Our modeling analyses suggest that genotype-guided therapy is a cost-effective strategy in patients with acute coronary syndrome undergoing planned percutaneous coronary intervention.
authors.affiliation: Department of Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago . Chicago, IL, ( United States ).
authors.forename: Vardhaman
authors.initials: V
authors.lastname: Patel
authors.affiliation: Pharmerit North America LLC, Bethesda, MD ( United States ).
authors.forename: Fang-Ju
authors.initials: FJ
authors.lastname: Lin
authors.affiliation: Pharmacoeconomic Center, Department of Defense. Fort Sam Houston, TX ( United States ).
authors.forename: Olaitan
authors.initials: O
authors.lastname: Ojo
authors.affiliation: Department of Epidemiology, University of North Carolina , Chapel Hill, NC ( United States ).
authors.forename: Sapna
authors.initials: S
authors.lastname: Rao
authors.affiliation: Global Health Outcomes, Merck Sharp & Dohme Corp. Whitehouse Station, NJ ( United States ).
authors.forename: Shengsheng
authors.initials: S
authors.lastname: Yu
authors.affiliation: Eisai Inc. Woodcliff Lake, NJ ( United States ).
authors.forename: Lin
authors.initials: L
authors.lastname: Zhan
authors.affiliation: Departments of Pharmacy Practice and Pharmacy Systems, Outcomes and Policy, University of Illinois at Chicago . Chicago, IL ( United States ). drtouche@uic.edu.
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Touchette
keywords: Acute Coronary Syndrome; Clopidogrel; Costs and Cost Analysis; Genetic; Genetic Testing; Polymorphism; Prasugrel; United States