Value, Access and Outcomes, ICON plc, New York, NY, USA.
Economics, Reimbursement & Evidence, Medtronic plc, Mounds View, MN, USA.
J Med Econ. 2020 Jul;23(7):690-697. doi: 10.1080/13696998.2020.1746316. Epub 2020 Apr 14.
Heart failure with reduced ejection fraction (HFrEF) has a substantial impact on costs and patients' quality-of-life. This study aimed to estimate the cost-effectiveness of implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT-P), cardiac resynchronization therapy defibrillators (CRT-D), and optimal pharmacologic therapy (OPT) in patients with HFrEF, from a US payer perspective. The analyses were conducted by adapting the UK-based cost-effectiveness analyses (CEA) to the US payer perspective by incorporating real world evidence (RWE) on baseline hospitalization risk and Medicare-specific costs. The CEA was based on regression equations estimated from data from 13 randomized clinical trials ( = 12,638). Risk equations were used to predict all-cause mortality, hospitalization rates, health-related quality-of-life, and device-specific treatment effects (vs. OPT). These equations included the following prognostic characteristics: age, QRS duration, New York Heart Association (NYHA) class, ischemic etiology, and left bundle branch block (LBBB). Baseline hospitalization rates were calibrated based on RWE from Truven Health Analytics MarketScan data (2009-2014). A US payer perspective, lifetime time horizon, and 3% discount rates for costs and outcomes were used. Benefits were expressed as quality-adjusted life-years (QALYs). Incremental cost-effectiveness analysis was conducted for 24 sub-groups based on LBBB status, QRS duration, and NYHA class. Results of the analyses show that CRT-D was the most cost-effective treatment at a $100,000/QALY threshold in 14 of the 16 sub-groups for which it is indicated. Results were most sensitive to changes in estimates of hospitalization costs. Study limitations include small sample sizes for NYHA I and IV sub-groups and lack of data availability for duration of treatment effect. CRT-D has higher greater cost-effectiveness across more sub-groups in the indicated patient populations against as compared to OPT, ICD, and CRT-P, from a US payer perspective.
射血分数降低的心力衰竭（HFrEF）对成本和患者生活质量有重大影响。本研究旨在从美国支付者的角度评估植入式心脏复律除颤器（ICD）、心脏再同步治疗起搏器（CRT-P）、心脏再同步治疗除颤器（CRT-D）和最佳药物治疗（OPT）在 HFrEF 患者中的成本效益。通过纳入关于基线住院风险和医疗保险特定成本的真实世界证据（RWE），从英国的成本效益分析（CEA）适应美国支付者的角度进行了分析。CEA基于从 13 项随机临床试验中估计的回归方程（ = 12,638）。风险方程用于预测全因死亡率、住院率、健康相关生活质量和设备特定治疗效果（与 OPT 相比）。这些方程包括以下预后特征：年龄、QRS 持续时间、纽约心脏协会（NYHA）分级、缺血性病因和左束支传导阻滞（LBBB）。根据 Truven Health Analytics MarketScan 数据（2009-2014）中的 RWE 校准了基线住院率。使用美国支付者的观点、终生时间范围和对成本和结果的 3%贴现率。效益表示为质量调整生命年（QALYs）。根据 LBBB 状态、QRS 持续时间和 NYHA 分级对 24 个子组进行了增量成本效益分析。分析结果表明，在 16 个有适应证的子组中，有 14 个子组 CRT-D 在 10 万美元/QALY 阈值下是最具成本效益的治疗方法。结果对住院费用估计的变化最为敏感。研究的局限性包括 NYHA I 和 IV 亚组的样本量较小以及缺乏治疗效果持续时间的数据可用性。从美国支付者的角度来看，与 OPT、ICD 和 CRT-P 相比，在有适应证的患者人群中，CRT-D 在更多的亚组中具有更高的成本效益。
