title: Economic Evaluation of Cinacalcet in the United States: The EVOLVE Trial.
abstract: BACKGROUND
  Previous economic evaluations of cinacalcet in patients with secondary hyperparathyroidism (sHPT) relied on the combination of surrogate end points in clinical trials and epidemiologic studies.
  
  
  OBJECTIVE
  The objective was to conduct an economic evaluation of cinacalcet on the basis of the EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) trial from a US payer perspective.
  
  
  METHODS
  We developed a semi-Markov model to assess the cost-effectiveness of cinacalcet in addition to conventional therapy, compared with conventional therapy alone, in patients with moderate-to-severe sHPT receiving hemodialysis. We used treatment effect estimates from the unadjusted intent-to-treat (ITT) analysis and prespecified covariate-adjusted ITT analysis as our main analyses. We assessed model sensitivity to variations in individual inputs and overall decision uncertainty through probabilistic sensitivity analyses.
  
  
  RESULTS
  The incremental cost-effectiveness ratio (ICER) for cinacalcet was $61,705 per life-year and $79,562 per quality-adjusted life-year (QALY) gained using the covariate-adjusted ITT analysis. Probabilistic sensitivity analysis suggested a 73.2% chance of the ICER being below a willingness-to-pay threshold of $100,000. Treatment effects from unadjusted ITT analysis yielded an ICER of $115,876 per QALY. The model was most sensitive to the treatment effect on mortality.
  
  
  CONCLUSIONS
  In the unadjusted ITT analysis, cinacalcet does not represent a cost- effective use of health care resources when applying a willingness-to-pay threshold of $100,000 per QALY. When using the covariate-adjusted ITT treatment effect, which represents the least biased estimate, however, cinacalcet is a cost-effective therapy for patients with moderate-to-severe sHPT on hemodialysis.
authors.affiliation: Amgen Inc., Thousand Oaks, CA, USA. Electronic address: vasilyb@amgen.com.
authors.forename: Vasily
authors.initials: V
authors.lastname: Belozeroff
authors.affiliation: Stanford University School of Medicine, Palo Alto, CA, USA.
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA.
authors.forename: Christopher N
authors.initials: CN
authors.lastname: Graham
authors.affiliation: Amgen Inc., Thousand Oaks, CA, USA.
authors.forename: Bastian
authors.initials: B
authors.lastname: Dehmel
authors.affiliation: Memorial University, St. John's, Newfoundland, Canada.
authors.forename: Patrick S
authors.initials: PS
authors.lastname: Parfrey
authors.affiliation: Health Economics & Health Technology Assessment, University of Glasgow, Glasgow, UK.
authors.forename: Andrew H
authors.initials: AH
authors.lastname: Briggs
mesh_terms: D000328:Adult; D000368:Aged; D057966:Calcimimetic Agents / Q000191:economics* / Q000627:therapeutic use*; D000069449:Cinacalcet / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000150:complications / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D017059:Models, Econometric; D019057:Quality-Adjusted Life Years; D006435:Renal Dialysis; D014481:United States
chemical_list: D057966:Calcimimetic Agents; D000069449:Cinacalcet
keywords: cinacalcet; cost-effectiveness; dialysis; hyperparathyroidism