Kandzari DE, Cao KN, Lobo MD, Sharp ASP, Schmieder RE, Esler MD, Pietzsch JB. Cost-Effectiveness of Renal Denervation for Uncontrolled Hypertension in the Presence of Antihypertensive Drugs: An Analysis for the U.S. Based on 6-Month Primary Results from the SPYRAL HTN-ON MED Randomized Trial. Podium Presentation at SCAI 2023 Scientific Sessions, Phoenix, AZ. May 20, 2023.

Background
In sham-controlled, randomized clinical trials, treatment with radiofrequency renal denervation (RF RDN) has been associated with statistically significant and clinically relevant reductions in blood pressure in the presence and absence of antihypertensive medications. We assessed health-economic implications of RDN, evaluating the lifetime cost-effectiveness of RF RDN using recent data from the SPYRAL HTN-ON MED randomized trial.

Methods
A decision-analytic model based on multivariate risk equations was used to project clinical events, quality-adjusted life years (QALYs) and costs over the patients’ lifetime. The model consists of six health states: hypertension alone, myocardial infarction, other symptomatic coronary artery disease, stroke, heart failure, and end-stage renal disease. Risk reduction associated with decreases in office systolic blood pressure (OSBP) in the treatment group was estimated based on a published meta-regression of 47 hypertension randomized trials. The base case effect size (change in OSBP, observed vs. sham control) was derived from the SPYRAL HTN-ON MED trial results, demonstrating a significant OSBP reduction compared with sham control among patients with uncontrolled hypertension prescribed up to three anti-hypertensive medications. The analysis was conducted from a US payer perspective, with a 3% discount rate applied to costs and effects. The incremental cost-effectiveness ratio (ICER) was evaluated against willingness-to-pay thresholds of $50,000 and $150,000 per QALY gained.

Results
RF RDN resulted in a relative risk reduction in clinical events over 10 years (0.80 for stroke, 0.88 for myocardial infarction, 0.72 for heart failure), with an increase in health benefit over a patient’s lifetime, adding 0.36 QALYs at a concurrent cost increase of $5,806, resulting in an ICER of $15,923 per QALY gained.

Conclusions
According to model-based projections of latest trial evidence, catheter-based RF RDN is expected to be a cost-effective strategy for uncontrolled hypertension in the United States healthcare system, with an ICER substantially below referenced cost-effectiveness thresholds.