Abstract

BackgroundThis study aimed to evaluate cost-utility of baroreflex activation therapy (BAT) using the Barostim neo™ device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, from a statutory health insurance perspective in Germany over a lifetime horizon.MethodsA decision analytic model was developed using the combination of a decision tree and the Markov process. The model included transitions between New York Heart Association (NYHA) health states, each of which is associated with a risk of mortality, hospitalization, cost, and quality of life. The effectiveness of BAT was projected through relative risks for mortality (obtained by application of patient-level data to the Meta-analysis Global Group in Chronic Heart Failure risk prediction model) and hospitalization owing to worsening of heart failure (obtained from BAT Randomized Clinical Trial). All patients were in NYHA class III at baseline.ResultsBAT led to an incremental cost of €33,185 (95% credible interval [CI] €24,561–38,637) and incremental benefits of 1.78 [95% CI 0.45–2.71] life-years and 1.19 [95% CI 0.30–1.81] quality-adjusted life-years (QALYs). This resulted in an incremental cost-effectiveness ratio of €27,951/QALY (95% CI €21,357–82,970). BAT had a 59% probability of being cost-effective at a willingness-to-pay threshold of €35,000/QALY (but 84% at a threshold of €52,000/QALY).ConclusionsBAT can be cost-effective in European settings in those not eligible for cardiac resynchronization therapy among patients with advanced heart failure.

Highlights

  • This study aimed to evaluate cost-utility of baroreflex activation therapy (BAT) using the Barostim neoTM device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, from a statutory health insurance perspective in Germany over a lifetime horizon

  • Base-case results In the analysis, BAT led to an incremental cost of €33,185 (95% credible interval €24,561–38,637) and incremental benefits of 1.78 (95% credible interval 0.45–2.71) life-years and 1.19 (95% credible interval 0.30–1.81) Quality-adjusted life-year (QALY) (Table 3)

  • This resulted in an incremental cost-effectiveness ratio (ICER) of €27,951/QALY (95% credible interval €21,357–82,970)

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Summary

Introduction

This study aimed to evaluate cost-utility of baroreflex activation therapy (BAT) using the Barostim neoTM device (CVRx Inc., Minneapolis, MN, USA) compared with optimized medical management in patients with advanced chronic heart failure (NYHA class III) who were not eligible for treatment with cardiac resynchronization therapy, from a statutory health insurance perspective in Germany over a lifetime horizon. Despite treatment advances over the past decade, heart failure (HF) remains a major burden on patients and healthcare systems. In patients with reduced left ventricular ejection fraction (LVEF), 1-year mortality was approximately 15%, increased to 22–25% at 3 years, and reached 72% at 10 years [7, 8]. Patients with HF have a reduced quality of life and are often limited in their activities of daily living because of symptoms, such as dyspnea and fatigue. The quality of life is reduced as symptoms worsen (New York Heart Association [NYHA] class) [10]

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