title: The cost-effectiveness of HLA-B*5801 screening to guide initial urate-lowering therapy for gout in the United States.
abstract: Positive HLA-B*5801 carriers are at greater risk of experiencing rare but severe allopurinol hypersensitivity syndrome (AHS) [i.e., Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)]; however, HLA-B*5801 prevalence and AHS risk vary by race/ethnicity. We evaluated the cost-effectiveness of HLA-B*5801 testing according to race/ethnicity in the United States.
  
  
  
  We determined the cost-effectiveness of universal testing for HLA-B*5801 compared to no testing prior to the initiation of allopurinol per US major race/ethnicity groups. Using US-specific data, SJS/TEN risks and HLA-B*5801 prevalences were modeled per race/ethnicity (i.e., 1/3846 and 0.7% among Caucasians and Hispanics, 1/735 and 3.8% among African Americans, and 1/336 and 7.4% among Asians, respectively). Those who tested positive for HLA-B*5801 received febuxostat. Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) were estimated over a lifetime.
  
  
  
  Compared to no testing, universal testing for HLA-B*5801 costs more and was more effective for all races/ethnicities. The ICERs varied substantially across racial/ethnic groups, following their HLA-B*5801 prevalences. HLA-B*5801 testing was cost-effective for African Americans (ICER $83,450) and Asians (ICER $64,190), but not for Caucasians or Hispanics (ICER $183,720), using accepted US willingness-to-pay threshold ($109,000/QALY). Results were robust in sensitivity analyses, except that reducing the risk of SJS/TEN by a half made testing not cost-effective for all races/ethnicities.
  
  
  
  Testing for HLA-B*5801 prior to allopurinol initiation is cost-effective for Asians and African Americans, but not for Caucasians or Hispanics in the United States. Reducing AHS risk by other predictive measures could make HLA-B*5801 testing not cost-effective even among Asians and Blacks.
authors.affiliation: Division of Health Policy and Management, School of Public Health, University of Minnesota, MMC 729, 420 Delaware St SE, Minneapolis, MN 55455. Electronic address: jutko001@umn.edu.
authors.forename: Eric
authors.initials: E
authors.lastname: Jutkowitz
authors.affiliation: Section of Clinical Epidemiology, Boston University School of Medicine, Boston, MA; Section of Rheumatology, VA Boston Healthcare System, Boston, MA.
authors.forename: Maureen
authors.initials: M
authors.lastname: Dubreuil
authors.affiliation: Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Boston, MA.
authors.forename: Na
authors.initials: N
authors.lastname: Lu
authors.affiliation: Division of Health Policy and Management, School of Public Health, University of Minnesota, MMC 729, 420 Delaware St SE, Minneapolis, MN 55455.
authors.forename: Karen M
authors.initials: KM
authors.lastname: Kuntz
authors.affiliation: Division of Rheumatology, Allergy, and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA. Electronic address: hchoi@partners.org.
authors.forename: Hyon K
authors.initials: HK
authors.lastname: Choi
mesh_terms: D001741:Black or African American; D000493:Allopurinol / Q000009:adverse effects*; D001213:Asian; D003362:Cost-Benefit Analysis; D005260:Female; D005819:Genetic Markers; D005820:Genetic Testing / Q000191:economics*; D006073:Gout / Q000188:drug therapy*; D006074:Gout Suppressants / Q000009:adverse effects*; D059949:HLA-B51 Antigen / Q000191:economics / Q000235:genetics*; D006801:Humans; D008297:Male; D012307:Risk Factors; D012680:Sensitivity and Specificity; D013262:Stevens-Johnson Syndrome / Q000208:ethnology / Q000235:genetics / Q000517:prevention & control; D014481:United States; D014527:Uric Acid
chemical_list: D005819:Genetic Markers; D006074:Gout Suppressants; D059949:HLA-B51 Antigen; D014527:Uric Acid; D000493:Allopurinol
keywords: Economic evaluations; Gout; Outcomes research