Cost-Effectiveness Analysis of Iodine-123 Meta-Iodobenzylguanidine Imaging for Screening Heart Failure Patients Eligible for an Implantable Cardioverter Defibrillator in the USA

Applied Health Economics and Health Policy June 2016, Volume 14, Issue 3, pp 361–373 | Cite as Cost-Effectiveness Analysis of Iodine-123 Meta-Iodobenzylguanidine Imaging for Screening Heart Failure Patients Eligible for an Implantable Cardioverter Defibrillator in the USA AuthorsAuthors and affiliations Ken O’DayWayne C. LevyMeridith JohnsonArnold F. Jacobson Open Access Original Research Article First Online: 14 March 2016 2 Shares 843 Downloads 3 Citations Abstract Background Many guideline-eligible heart failure (HF) patients do not receive a survival benefit from implantable cardioverter defibrillators (ICDs). Improved risk stratification may help to reduce costs and improve the cost effectiveness of ICDs. Objective To estimate the potential outcomes, costs, and cost effectiveness of using iodine-123 meta-iodobenzylguanidine (I-mIBG) to screen HF patients eligible for an ICD. Methods A decision-analytic model was developed to compare screening with I-mIBG imaging and no screening over 2-year and 10-year time horizons from a US payer perspective. Data on I-mIBG imaging and risk stratification were obtained from the ADMIRE-HF/HFX (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) trial. Data on ICD effectiveness for prevention of sudden cardiac death (SCD) were obtained from a meta-analysis. Costs of ICDs and costs of generator and lead procedures were obtained from the Agency for Healthcare Research and Quality National Inpatient Sample. Age-specific mortality was modeled using US life tables and data from the ACT (Advancements in ICD Therapy) Registry on risks of SCD and non-SCD mortality. Sensitivity analyses were conducted. Results In the analysis, screening with I-mIBG imaging was associated with a reduction in ICD utilization of 21 %, resulting in a number needed to screen to prevent 1 ICD implantation of 5. Screening reduced the costs per patient by US$5500 and US$13,431 (in 2013 dollars) over 2 and 10 years, respectively, in comparison with no screening and resulted in losses of 0.001 and 0.040 life-years, respectively, over 2 and 10 years. Screening was decrementally cost effective, with savings of US$5,248,404 and US$513,036 per quality-adjusted life-year lost over 2 and 10 years, respectively. In subgroup analyses, cost savings were greater for patients with an ejection fraction (EF) of 25–35 % than for those with an EF <25 %. Conclusions According to the model, screening of guideline-eligible patients selected for ICDs with I-mIBG imaging may be cost effective and may help reduce costs associated with implantation of ICDs, with a minimal impact on survival. KeywordsLeft Ventricular Ejection Fraction Sudden Cardiac Death Heart Failure Patient Implantable Cardioverter Defibrillator Probabilistic Sensitivity Analysis  These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves. Key Points for Decision Makers Over 2 and 10 years, this analysis found that screening had the potential to reduce costs by US$5500 and US$13,431, respectively, with less than 1 day and 2 weeks of life lost, respectively, per patient. Screening was cost effective, with savings of US$5,248,404 and US$513,036 per quality-adjusted life-year lost, respectively, over 2-year and 10-year horizons. Screening improved the cost effectiveness of implantable cardioverter defibrillators (ICDs) by approximately 10 %. Iodine-123 meta-iodobenzylguanidine (I-mIBG) screening may help healthcare policy makers control costs associated with provision of ICDs to guideline-eligible patients, with a minimal impact on patient mortality. 1 Introduction Sudden cardiac death (SCD) accounts for 300,000–400,000 deaths annually in the USA [1]. Risk factors for SCD include age, male sex, coronary artery disease, a prior coronary event, and heart failure (HF) [2]. American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Rhythm Society (HRS) guidelines recommend implantable cardioverter defibrillators (ICDs) for primary prevention of SCD in patients with New York Heart Association (NYHA) class II or III HF and a left ventricular ejection fraction (LVEF) ≤35 % due to prior myocardial infarction and in patients with non-ischemic dilated cardiomyopathy and NYHA class I HF of ischemic etiology and an LVEF <30 % [3]. Selection of patients for an ICD is heavily influenced by the ejection fraction (EF), given its use in guidelines (≤35 % for NYHA class II–III or ≤30 % for ischemic NYHA class I) and the corresponding evidence base from clinical trials demonstrating efficacy of ICDs in HF patients with a reduced EF [4, 5, 6]. Cost-effectiveness analyses, including a recent systematic review, have generally found ICDs to be cost effective [7]. However, a substantial proportion of patients receiving ICDs will obtain no survival benefit from the device, as they will die of other causes prior to any ICD shocks. As the ICD-eligible patient population includes individuals at varying risk of arrhythmic death, additional risk stratification of patients may help to reduce costs and improve the cost effectiveness of ICDs by identifying patients at lower risk of arrhythmic death or at higher risk of non-arrhythmic death who are not likely to obtain a meaningful benefit from ICDs [8, 9, 10]. Iodine-123 meta-iodobenzylguanidine (I-mIBG) is a molecular imaging agent, which received US Food and Drug Administration (FDA) approval in 2013 for scintigraphic imaging assessment of sympathetic innervation of the myocardium to assist in the evaluation of adult patients with NYHA class II or III HF and an LVEF ≤35 % to help identify patients with lower 1- and 2-year mortality risks as indicated by a heart/mediastinum (H/M) ratio ≥1.6. The ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) trial prospectively studied I-mIBG imaging in predicting prognosis for significant cardiac events [11]. Patients in ADMIRE-HF with an H/M ratio ≥1.6 had significantly reduced risks of a cardiac event [hazard ratio (HR) 0.40, P < 0.001], HF progression (HR 0.49; P = 0.002), potentially life-threatening arrhythmia (HR 0.37; P = 0.020), and cardiac death (HR 0.14; P = 0.006) in comparison with patients with an H/M ratio <1.6 [11]. The addition of I-mIBG to a number of multivariable risk models, including the Seattle Heart Failure Model, was found to improve risk stratification in comparison with the risk models alone [12, 13]. In selecting HF patients for an ICD, clinicians and patients must balance potential survival benefits against potential risks. Identification of patients at low risk of a significant cardiac event with I-mIBG imaging may help to provide decision support to clinicians regarding patients who may not want an ICD or where there is uncertainty about whether the risks associated with an ICD may outweigh the potential benefi (...truncated)