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

David E. Kandzari MD , Khoa N. Cao MBBS, MPH, MS , Anne M. Ryschon MA , Andrew S.P. Sharp MBChB, MD , Jan B. Pietzsch PhD
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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.
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美国基于导管的射频肾脏去神经支配:基于当代证据的成本效益分析
背景导管射频肾脏去神经支配(RF RDN)最近被批准作为血压控制不佳的高血压患者的辅助治疗手段。该研究根据当代临床证据评估了 RF RDN 在美国的成本效益。方法一个决策分析马尔可夫模型预测了接受 RF RDN 治疗的活跃队列和接受标准护理(定义为 1、2 或 3 种降压药)治疗的对照队列的成本、质量调整生命年 (QALY) 和临床事件。队列人口统计学和治疗效果来自 SPYRAL HTN-ON MED 研究,该研究显示,与假对照组相比,诊室收缩压绝对值降低了 9.9 mm Hg,降低了 4.9 mm Hg。降压带来的临床事件风险降低是基于 47 项高血压试验的元回归结果。根据每 QALY 5 万美元(高值)和每 QALY 15 万美元(中值)的支付意愿阈值对增量成本效益比进行了评估。结果RF RDN显著降低了临床事件风险(10年内中风风险为0.80,心肌梗死风险为0.88,心血管死亡风险为0.85)。在整个生命周期中,RF RDN 增加了 0.34 QALY,额外成本为 11,275 美元,因此每 QALY 的增量成本效益比为 32,732 美元。RF RDN 的成本效益在各种情况和敏感性分析中都是稳健的。结论根据终生预测,对于未得到控制的高血压患者而言,基于导管的 RF RDN 是一项具有成本效益的高价值干预措施。
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