Cost-effectiveness of RF RDN in ESC Hypertension guideline-recommended indications in six European countries: an analysis based on Global SYMPLICITY Registry DEFINE data

Background/Introduction Radiofrequency renal denervation (RF RDN) is recommended as an adjunct treatment option for uncontrolled hypertension, including patients with resistant hypertension and patients with increased cardiovascular disease (CVD) risk, per ESC guidelines. Purpose This analysis evaluated the cost-effectiveness of RF RDN in ESC Hypertension guideline-recommended patient groups – defined as patients with office blood pressure (BP) ≥140/90 mmHg on ≥3 antihypertensive (AH) drugs (Group 1) and patients with BP ≥140/90 mmHg and increased CVD risk on <3 AH drugs (Group 2) – in the UK, Spain, Netherlands, Belgium, Sweden, and the Czech Republic, using contemporary registry data. Methods A previously published decision-analytic framework informed country-specific Markov models projecting strategy-specific costs, clinical events, and quality-adjusted life years (QALYs) over a lifetime horizon. Transitions between health states were informed by multivariate risk equations. Three-year data from the Global Symplicity Registry (GSR) DEFINE informed cohort characteristics and treatment effects (mean age and BP reduction from baseline: 60 years and -20.6 mmHg for Group 1; 63 years and -18.8 mmHg for Group 2). Country-specific data and cost-effectiveness guidelines informed key assumptions and results interpretation. The primary outcome was the incremental cost-effectiveness ratio (ICER), evaluated against established willingness-to-pay thresholds of £20,000, €25,000, €20,000, €40,000, SEK 500,000, and 1,200,000 Kcˇ per QALY gained in the UK, Spain, Netherlands, Belgium, Sweden, and Czech Republic settings, respectively. Results For Group 1, incremental costs, QALYs, and resulting ICERs with RF RDN were: - UK: £1,451 (£24,067 vs. £22,616), 0.82 (12.82 vs. 11.99) QALYs, £1,760 per QALY gained - Spain: €2,338 (€24,860 vs. €22,521), 0.82 (13.08 vs. 12.26) QALYs, €2,849 per QALY gained - Netherlands: -€3,447 (€45,916 vs. €49,363), 1.33 (16.08 vs. 14.75) QALYs, dominant - Belgium: €686 (€47,719 vs. €47,033), 1.23 (16.02 vs. 14.79) QALYs, €556 per QALY gained - Sweden: SEK 24,791 (SEK 461,905 vs. SEK 437,114), 1.03 (13.71 vs. 12.69) QALYs, SEK 24,134 per QALY gained - Czech Republic: 154,604 Kcˇ (383,639 Kcˇ vs. 229,035 Kcˇ), 1.01 (12.79 vs. 11.78) QALYs, 152,604 Kcˇ per QALY gained For Group 2, ICERs were slightly less favorable, but remained highly cost-effective at £2,928, €4,090, dominant, €1,612, SEK 37,180, and 177,679 Kcˇ in the UK, Spain, Netherlands, Belgium, Sweden, and the Czech Republic analyses. The cost of RF RDN treatment was largely or fully amortized by cost-savings from avoided downstream clinical events, which coupled with meaningful quality of life improvements, resulted in robust cost-effectiveness findings across all scenarios. Conclusion RF RDN was found to be highly cost-effective or dominant in the ESC Hypertension guideline-recommended groups across six European countries.