Catheter-Based Radiofrequency Renal Denervation in the United States: A Cost-Effectiveness Analysis Based on Contemporary Evidence

Abstract

Background: Catheter-based radiofrequency renal denervation (RF RDN) has recently been approved as an adjunctive treatment for hypertensive patients without adequate blood pressure control. This study assessed the cost-effectiveness of RF RDN in the United States based on contemporary clinical evidence.

Methods: A decision-analytic Markov model projected costs, quality-adjusted life years (QALY), and clinical events for an active cohort treated with RF RDN and a control cohort treated with standard-of-care (defined as 1, 2, or 3 antihypertensive medications). Cohort demographics and therapy effect were derived from the SPYRAL HTN-ON MED study demonstrating an absolute 9.9 mm Hg reduction in office systolic blood pressure and 4.9 mm Hg reduction compared with sham control. Clinical event risk reduction from blood pressure lowering was based on a meta-regression of 47 hypertension trials. The incremental cost-effectiveness ratio was evaluated against willingness-to-pay thresholds of $50,000 per QALY (high value) and $150,000 per QALY (intermediate value). Extensive scenario and sensitivity analyses were conducted to assess robustness of the findings.

Results: RF RDN yielded a significant risk reduction in clinical events (0.80 for stroke, 0.88 for myocardial infarction, and 0.85 for cardiovascular death over 10 years). Over lifetime, RF RDN added 0.34 QALY at an additional cost of $11,275, leading to an incremental cost-effectiveness ratio of $32,732 per QALY. The cost-effectiveness of RF RDN was robust across a broad range of scenarios and sensitivity analyses.

Conclusions: Based on a lifetime projection, catheter-based RF RDN is a cost-effective, high-value intervention for hypertensive patients with uncontrolled hypertension.

Keywords: United States; cost-effectiveness analysis; radio frequency ablation; resistant hypertension.

Figure 1

Schematic representation of the Markov model (based on Geisler et al⁶). AP/other CHD, angina pectoris/other coronary heart disease; ESRD, end-stage renal disease; HF, heart failure; MI, myocardial infarction.

Figure 2

Relative risks (RR) of clinical events at 10 years for radiofrequency renal denervation (RDN) effect size vs sham control (top) and vs baseline (bottom). The base case analysis relies on the effect observed vs sham. ACD, all-cause death; AP/CHD, angina pectoris/coronary heart disease; CVD, cardiovascular death; ESRD, end-stage renal disease; HF, heart failure; MI, myocardial infarction; SoC, standard of care.

Central Illustration

Cost-effectiveness of radiofrequency renal denervation (RF RDN) in the United States. Incremental cost-effectiveness ratio (ICER) related to patient age establishing radiofrequency renal denervation as a cost-effective, high-value therapy. QALY, quality-adjusted life-years.

Figure 3

Sensitivity analysis results: incremental cost-effectiveness ratio (ICER) dependent on treatment age (A), baseline office systolic blood pressure (OSBP)(B), and effect size (C). All scenarios shown for base case (unadjusted event risk functions), and down- and up-adjusted baseline event risk (factors 0.5 and 2.0, respectively). QALY, quality-adjusted life-years.

Figure 4

Probabilistic sensitivity analysis results: incremental cost-effectiveness ratio scatterplot (A) and cost-effectiveness acceptability curve (B). Each graph shows results for base case (unadjusted event risk functions), and down- and up-adjusted baseline event risk (factors 0.5 and 2.0, respectively). QALY, quality-adjusted life-years; WTP, willingness-to-pay.