Radiofrequency Renal Denervation for Uncontrolled Hypertension: A Cost-Effectiveness Analysis for the Belgian Setting Based on SPYRAL HTN-ON MED and Other Contemporary Evidence

OBJECTIVES: Radiofrequency renal denervation (RF RDN) is a therapeutic option for uncontrolled, including resistant, hypertension. This study examined the cost-effectiveness of RF RDN from the perspective of the Belgian healthcare payer.

METHODS: A decision-analytic Markov model projected clinical events, quality-adjusted survival and costs with a time horizon of ten years and lifetime. Clinical events projected included stroke, myocardial infarction (MI), angina pectoris/coronary heart disease (AP/CHD), heart failure (HF), end-stage renal disease (ESRD), cardiovascular death (CVD), and all-cause death (ACD). The model was based on multivariate risk equations, including the Framingham equations. Clinical event risk reductions associated with changes in office systolic blood pressure (oSBP) were estimated based on a meta-regression of 47 hypertension treatment-related randomized controlled trials (RCTs). Demographics and treatment effects (-4.9 mmHg, active vs sham oSBP,) were derived from the SPYRAL HTN-ON MED trial. The analysis was conducted from the perspective of the Belgian healthcare payer, including associated healthcare costs, with a 3.0% discount rate for costs and a 1.5% discount rate for health effects as per Belgian guidelines. Ten-year clinical event relative risks (RR) and the lifetime incremental cost-effectiveness ratio (ICER) were calculated. The ICER was evaluated against a willingness-to-pay threshold of €40,000 per quality-adjusted life year (QALY) gained.

RESULTS: RF RDN led to a significant clinical event RR reduction (0.80 for stroke, 0.88 for MI, 0.89 for AP/CHD, 0.72 for HF, 0.96 for ESRD, 0.85 for CVD, and 0.93 for ACD). Compared to sham therapy, RF RDN led to an incremental QALY gain of 0.57 at an incremental cost of €5,218, yielding an ICER of €9,089 per QALY gained, substantially below willingness-to-pay thresholds referenced for Belgium.

CONCLUSIONS: Based on model-based projections, RF RDN is expected to lead to meaningful event risk reductions and can provide a cost-effective treatment alternative for uncontrolled hypertension in the Belgian setting.