To assess the cost-effectiveness of cardiac resynchronisation therapy (CRT) both with CRT-P (biventricular pacemaker only) and with CRT-D (biventricular pacemaker with defibrillator) in patients with New York Heart Association (NYHA) functional class III/IV from a Belgian healthcare-payer perspective.
A lifetime Markov model was designed to calculate the cost–utility of both interventions. In the reference case, the treatment effect was based on the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure trial. Costs were based on real-world data. Pharmacoeconomic guidelines were applied, including probabilistic modelling and sensitivity analyses.
Compared with optimal medical treatment, on average 1.31 quality-adjusted life-years (QALY) are gained with CRT-P at an additional cost of €14 700, resulting in an incremental cost-effectiveness ratio (ICER) of about €11 200/QALY. As compared with CRT-P, CRT-D treatment adds on average an additional 0.55 QALYs at an extra cost of €30 900 resulting in an ICER of €57 000/QALY. This result was very sensitive to the incremental clinical benefit of the defibrillator function on top of CRT.
Based on efficiency arguments, CRT-P can be recommended for NYHA class III and IV patients if there is a willingness to pay more than €11 000/QALY. Even though CRT-D may offer a survival benefit over CRT-P, the incremental clinical benefit appears to be too marginal to warrant a threefold-higher device price for CRT-D. Further clinical research should focus on the added value of CRT-D over CRT-P.
To assess the cost-effectiveness of cardiac resynchronisation therapy (CRT) both with CRT-P (biventricular pacemaker only) and with CRT-D (biventricular pacemaker with defibrillator).
CRT-P can be recommended for reimbursement for New York Heart Association class III and IV patients if there is a willingness to pay more than €11 000/quality-adjusted life-year.
Current evidence is insufficient to show the superiority of CRT-D over CRT-P. With a threefold-higher device cost, CRT-D's cost-effectiveness is questionable.
Strengths and limitations
Hospital billing data of 342 Belgian CRT implantations were at our disposal for cost calculations.
The results of the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure trial were used to model the treatment effect. This happens to be the only trial that compared CRT-P as well as CRT-D versus optimal pharmacological treatment, allowing an indirect comparison to be made between CRT-P and CRT-D.
Following health economic theory, CRT-D is compared with CRT-P, not with optimal pharmacological treatment (ie, working on the cost-efficiency frontier).
A direct estimate of the added value of CRT-D versus CRT-P in patients with moderate to severe heart failure is lacking. This may be an interesting topic for further research in a randomised controlled trial, especially because of the threefold higher price for a CRT-D device versus CRT-P.
Generic utility instruments to measure quality of life are not always used in clinical trials. To support economic evaluations, it would be useful to include more systematically a generic utility instrument in the study protocol.