Economic Evaluation of Cinacalcet in the United States: The EVOLVE Trial

Value Health. 2015 Dec;18(8):1079-87. doi: 10.1016/j.jval.2015.08.007. Epub 2015 Oct 9.

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.

Objectives: 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.

Keywords: cinacalcet; cost-effectiveness; dialysis; hyperparathyroidism.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Calcimimetic Agents / economics*
  • Calcimimetic Agents / therapeutic use*
  • Cinacalcet / economics*
  • Cinacalcet / therapeutic use*
  • Cost-Benefit Analysis
  • Double-Blind Method
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / complications
  • Hyperparathyroidism, Secondary / drug therapy*
  • Hyperparathyroidism, Secondary / etiology
  • Hyperparathyroidism, Secondary / mortality
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / therapy
  • Male
  • Markov Chains
  • Middle Aged
  • Models, Econometric
  • Quality-Adjusted Life Years
  • Renal Dialysis
  • United States

Substances

  • Calcimimetic Agents
  • Cinacalcet