Cost Effectiveness of Endovascular Ultrasound Renal Denervation in Patients with Resistant Hypertension

Rod S. Taylor (), Anthony Bentley, Kaylie Metcalfe, Melvin D. Lobo, Ajay J. Kirtane, Michel Azizi, Christopher Clark, Kieran Murphy, Jennifer H. Boer, Marjolijn Keep, An Thu Ta, Neil C. Barman, Garrett Schwab, Ron Akehurst and Roland E. Schmieder
Additional contact information
Rod S. Taylor: University of Glasgow
Anthony Bentley: Mtech Access Limited
Kaylie Metcalfe: Mtech Access Limited
Melvin D. Lobo: Queen Mary University of London
Ajay J. Kirtane: Columbia University Irving Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation
Michel Azizi: Université de Paris
Christopher Clark: University of Exeter Medical School
Kieran Murphy: ReCor Medical
Jennifer H. Boer: BresMed Netherlands
Marjolijn Keep: BresMed Netherlands
An Thu Ta: BresMed Netherlands
Neil C. Barman: ReCor Medical
Garrett Schwab: ReCor Medical
Ron Akehurst: BresMed Health Solutions
Roland E. Schmieder: Friedrich Alexander University

PharmacoEconomics - Open, 2024, vol. 8, issue 4, No 3, 525-537

Abstract: Abstract Background Resistant hypertension (rHTN) is defined as blood pressure (BP) of ≥ 140/90 mmHg despite treatment with at least three antihypertensive medications, including a diuretic. Endovascular ultrasound renal denervation (uRDN) aims to control BP alongside conventional BP treatment with antihypertensive medication. This analysis assesses the cost effectiveness of the addition of the Paradise uRDN System compared with standard of care alone in patients with rHTN from the perspective of the United Kingdom (UK) health care system. Methods Using RADIANCE-HTN TRIO trial data, we developed a state-transition model. Baseline risk was calculated using Framingham and Prospective Cardiovascular Münster (PROCAM) risk equations to estimate the long-term cardiovascular risks in patients treated with the Paradise uRDN System, based on the observed systolic BP (SBP) reduction following uRDN. Relative risks sourced from a meta-analysis of randomised controlled trials were then used to project cardiovascular events in patients with baseline SBP (‘control’ patients); utility and mortality inputs and costs were derived from UK data. Costs and outcomes were discounted at 3.5% per annum. Modelled outcomes were validated against trial meta-analyses and the QRISK3 algorithm and real-world evidence of RDN effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty surrounding the model inputs and sensitivity of the model results to changes in parameter inputs. Results were reported as incremental cost-effectiveness ratios (ICERs). Results A mean reduction in office SBP of 8.5 mmHg with uRDN resulted in an average improvement in both absolute life-years (LYs) and quality-adjusted life-years (QALYs) gained compared with standard of care alone (0.73 LYs and 0.67 QALYs). The overall base-case ICER with uRDN was estimated at £5600 (€6500) per QALY gained (95% confidence interval £5463–£5739 [€6341–€6661]); modelling demonstrated > 99% probability that the ICER is below the £20,000–£30,000 (€23,214–€34,821) per QALYs gained willingness-to-pay threshold in the UK. Results were consistent across sensitivity analyses and validation checks. Conclusions Endovascular ultrasound RDN with the Paradise system offers patients with rHTN, clinicians, and healthcare systems a cost-effective treatment option alongside antihypertensive medication.

Date: 2024
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DOI: 10.1007/s41669-024-00472-z

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