Ex ante economic evaluation of genetic testing for the ARG389 beta1-adrenergic receptor polymorphism to support bucindolol treatment decisions in Stage III/IV heart failure

Background: Sub-analyses from the BEST trial in heart failure (HF) indicated that Arg389 homozygote patients may respond to bucindolol. Bucindolol is currently being evaluated in Arg389 genotype patients in the GENETIC-AF trial. Our aim is to conduct ex ante economic evaluations of Arg389 genetic testing to support β-blocker treatment in HF. Methods: Using survival results from two BEST sub-analyses, we constructed a decision-tree model (time-horizon 18 months, divided into three 6-month cycles) to estimate the cost-effectiveness/utility of Arg389 genetic testing with bucindolol or carvedilol versus no testing and empirical bucindolol. Costs of bucindolol and genetic testing were set conservatively at 1.5x carvedilol cost and $250, respectively. Incremental cost-effectiveness (ICER) and cost-utility ratios (ICUR) were estimated. Results: Per one BEST sub-analysis, Arg389 genetic testing was associated with incremental gains of 0.29 life-years (LYs) and 0.27 quality-adjusted life years (QALYs) at incremental costs of $726; yielding ICER of US$2,503/LY and ICUR of US$2,688/QALY gained. Per a different BEST sub-analysis, Arg-389 genetic testing was associated with incremental gains of 0.35LYs and 0.32QALYs at savings of (US$1,081); for ICER of (US$3,089)/LY and ICUR of (US$3,378)/QALY gained. Conclusions: Assuming conservative cost estimates, Arg389 genetic testing to inform bucindolol versus carvedilol treatment decisions prevailed economically over bucindolol treatment without genetic testing.