title: Cost-effectiveness of gemcitabine + cisplatin vs. gemcitabine monotherapy in advanced biliary tract cancer.
abstract: OBJECTIVE
  The ABC-02 trial demonstrated a statistically significant survival benefit associated with the addition of cisplatin to gemcitabine in the palliative treatment of advanced biliary tract cancer (BTC). Based on the ABC-02 findings, this analysis seeks to evaluate the cost-utility of adding cisplatin to standard gemcitabine therapy from a U.S. societal perspective.
  
  
  METHODS
  A decision-analytic model was developed to estimate direct medical costs, patient time costs, and quality-adjusted life-years (QALYs) for two treatment strategies: (1) gemcitabine + cisplatin, (2) gemcitabine monotherapy. Model parameters were derived from the pivotal trial of gemcitabine + cisplatin in advanced BTC, published literature, and government sources. The model included trial-based adverse events and costs related to drug treatment, routine follow-up, adverse events, and post-progression care. The model results were examined using one-way and probabilistic sensitivity analyses (PSA).
  
  
  RESULTS
  Total QALYs for the gemcitabine + cisplatin and gemcitabine monotherapy strategies were 0.751 and 0.561, respectively. Total costs were $44,885 and $33,653 respectively. Relative to gemcitabine monotherapy, gemcitabine + cisplatin had an incremental cost-effectiveness ratio (ICER) of $59,480 per QALY gained. One-way sensitivity analyses found results to be sensitive to progression-free survival, overall survival, pre and post-progression health state utility values, and the cost of post-progression care. In the PSA, gemcitabine monotherapy had the highest probability of being cost-effective until a willingness-to-pay of $60,000, after which the gemcitabine + cisplatin strategy had the highest probability.
  
  
  CONCLUSIONS
  The results of this analysis suggest that in advanced BTC, the cisplatin + gemcitabine regimen is a cost-effective treatment alternative to gemcitabine monotherapy by currently accepted standards of willingness to pay.
authors.affiliation: Department of Pharmacy, University of Washington, Seattle, WA 98195, USA. rothja@uw.edu
authors.forename: Joshua A
authors.initials: JA
authors.lastname: Roth
authors.forename: Josh J
authors.initials: JJ
authors.lastname: Carlson
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy / Q000191:economics* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage / Q000191:economics*; D017326:Clinical Trials, Phase III as Topic; D003362:Cost-Benefit Analysis / Q000191:economics; D003661:Decision Support Techniques; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics; D018572:Disease-Free Survival; D006801:Humans; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine