title: Cost effectiveness of fibrosis assessment prior to treatment for chronic hepatitis C patients.
abstract: OBJECTIVE
  Chronic hepatitis C (HCV) is a liver disease affecting over 3 million Americans. Liver biopsy is the gold standard for assessing liver fibrosis and is used as a benchmark for initiating treatment, though it is expensive and carries risks of complications. FibroTest is a non-invasive biomarker assay for fibrosis, proposed as a screening alternative to biopsy.
  
  
  METHODS
  We assessed the cost-effectiveness of FibroTest and liver biopsy used alone or sequentially for six strategies followed by treatment of eligible U.S. patients: FibroTest only; FibroTest with liver biopsy for ambiguous results; FibroTest followed by biopsy to rule in; or to rule out significant fibrosis; biopsy only (recommended practice); and treatment without screening. We developed a Markov model of chronic HCV that tracks fibrosis progression. Outcomes were expressed as expected lifetime costs (2009 USD), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER).
  
  
  RESULTS
  Treatment of chronic HCV without fibrosis screening is preferred for both men and women. For genotype 1 patients treated with pegylated interferon and ribavirin, the ICERs are $5,400/QALY (men) and $6,300/QALY (women) compared to FibroTest only; the ICERs increase to $27,200/QALY (men) and $30,000/QALY (women) with the addition of telaprevir. For genotypes 2 and 3, treatment is more effective and less costly than all alternatives. In clinical settings where testing is required prior to treatment, FibroTest only is more effective and less costly than liver biopsy. These results are robust to multi-way and probabilistic sensitivity analyses.
  
  
  CONCLUSIONS
  Early treatment of chronic HCV is superior to the other fibrosis screening strategies. In clinical settings where testing is required, FibroTest screening is a cost-effective alternative to liver biopsy.
authors.affiliation: Department of Management Science and Engineering, Stanford University, Stanford, California, United States of America. shanliu@stanford.edu
authors.forename: Shan
authors.initials: S
authors.lastname: Liu
authors.forename: Michaël
authors.initials: M
authors.lastname: Schwarzinger
authors.forename: Fabrice
authors.initials: F
authors.lastname: Carrat
authors.forename: Jeremy D
authors.initials: JD
authors.lastname: Goldhaber-Fiebert
mesh_terms: D000328:Adult; D000368:Aged; D000465:Algorithms; D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use; D015415:Biomarkers / Q000378:metabolism; D001706:Biopsy / Q000379:methods; D003362:Cost-Benefit Analysis; D018450:Disease Progression; D005260:Female; D005355:Fibrosis / Q000191:economics* / Q000378:metabolism / Q000628:therapy*; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000191:economics* / Q000628:therapy*; D006801:Humans; D008099:Liver / Q000473:pathology; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D011336:Probability; D019057:Quality-Adjusted Life Years; D018570:Risk Assessment
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers