Cardiothoracic Surgery, Freeman Hospital, Newcastle, UK.
Cardiothoracic Surgery, Advent Health Transplant Institute, Orlando, FL, USA.
ESC Heart Fail. 2021 Aug;8(4):3049-3057. doi: 10.1002/ehf2.13401. Epub 2021 May 27.
Continuous-flow left ventricular assist devices (LVADs) as destination therapy (DT) are a recommended treatment by National Institute for Health and Care Excellence England for end-stage heart failure patients ineligible for cardiac transplantation. Despite the fact that DT is frequently used as an LVAD indication across other major European countries and the United States, with consistent improvements in quality-of-life and longevity, National Health Service (NHS) England does not currently fund DT, mainly due to concerns over cost-effectiveness. On the basis of the recently published ENDURANCE Supplemental Trial studying DT patients, we assessed for the first time the cost-effectiveness of DT LVADs compared with medical management (MM) in the NHS England.
We developed a Markov multiple-state economic model using NHS cost data. LVAD survival and adverse event rates were derived from the ENDURANCE Supplemental Trial. MM survival was based on Seattle Heart Failure Model estimates in the absence of contemporary clinical trials for this population. Incremental cost-effectiveness ratios (ICERs) were calculated over a lifetime horizon. A discount rate of 3.5% per year was applied to costs and benefits. Deterministic ICER was £46 207 per quality-adjusted life year (QALY). Costs and utilities were £204 022 and 3.27 QALYs for the LVAD arm vs. £77 790 and 0.54 QALYs for the MM arm. Sensitivity analyses confirmed robustness of the primary analysis.
The implantation of the HeartWare™ HVAD™ System in patients ineligible for cardiac transplantation as DT is a cost-effective therapy in the NHS England healthcare system under the end-of-life willingness-to-pay threshold of £50 000/QALY, which applies for VAD patients.
连续流动左心室辅助装置（LVAD）作为终末期心力衰竭患者心脏移植禁忌的治疗选择，被英国国家卫生与保健优化研究所推荐为心脏移植的替代疗法（destination therapy，DT）。尽管 DT 在其他主要欧洲国家和美国被广泛应用于 LVAD 适应证，并一致改善了生活质量和延长了生存时间，但英国国家医疗服务体系（NHS）目前并不为 DT 提供资金，主要是因为对成本效益的担忧。基于最近发表的 ENDURANCE 补充试验研究 DT 患者，我们首次评估了 DT LVAD 与 NHS 英格兰的药物治疗（medical management，MM）相比的成本效益。
我们使用 NHS 成本数据开发了一个马尔可夫多状态经济模型。LVAD 生存率和不良事件发生率来自 ENDURANCE 补充试验。在没有针对该人群的当代临床试验的情况下，MM 生存率基于西雅图心力衰竭模型的估计。在终身时间范围内计算增量成本效益比（incremental cost-effectiveness ratio，ICER）。对成本和效益应用了 3.5%的年贴现率。确定的 ICER 为每质量调整生命年（quality-adjusted life year，QALY）46207 英镑。LVAD 组的成本和效用为 204022 英镑和 3.27 QALY，而 MM 组的成本和效用为 77790 英镑和 0.54 QALY。敏感性分析证实了主要分析的稳健性。
在 NHS 英格兰医疗体系中，对于不适合心脏移植的患者，植入 HeartWare™ HVAD™ 系统作为 DT 是一种具有成本效益的治疗方法，符合 VAD 患者 50000 英镑/QALY 的终末期意愿支付阈值。
