Spath Marian A, O'Brien Bernie J
Centre for Evaluation of Medicines, McMaster University, Hamilton, Ontario, Canada.
Pharmacoeconomics. 2002;20(11):727-38. doi: 10.2165/00019053-200220110-00002.
The implantable cardioverter defibrillator (ICD) is a therapy for patients at risk of sudden cardiac death due to ventricular tachycardia (VT) or ventricular fibrillation (VF). But the apparent high cost of ICD therapy relative to antiarrhythmic drugs such as amiodarone has raised questions about the cost effectiveness of ICD therapy versus drug therapy. To inform this debate we reviewed the literature on ICD cost effectiveness. An electronic and manual search was conducted for articles published since 1980 reporting original data on the cost effectiveness of ICD versus drug therapy for patients at risk of VT/VF. Data on costs and life-years gained were abstracted and studies were grouped into those that used decision-analysis models and those that were trial-based analyses. Cost-effectiveness ratios were inflated to 2001 US dollars. Nine studies were included in the review; five studies were modelling studies and four were part of randomised trials of ICD therapy. Studies varied in time horizon, but all except one indicated that ICD therapy was more costly than drug therapy. Early decision models assumed larger survival benefits than those observed in subsequent trials and therefore had attractive incremental cost-effectiveness ratios in the range of dollars US 27000 to dollars US 60000 per life-year gained. Trial-based studies, with the exception of one small trial, indicated cost per life-year gained in the range dollars US 44000 to dollars US 144000. Stratified analysis shows clearly that patients with a greater risk of mortality due to structural heart disease (e.g. left ventricular ejection fraction < or =35%) benefit more from ICD therapy and therefore have a more attractive cost effectiveness ratio than patients at lower risk. ICD therapy is still evolving over time with implant costs declining and device technology improving. Current evidence is that, in selected patients who are at high risk of VT/VF, ICD therapy can be a cost-effective option. Future research should focus on (i) patient selection to optimise benefits for available resources; and (ii) more comprehensive outcome measures to include health-related quality of life.
植入式心脏复律除颤器(ICD)是用于治疗因室性心动过速(VT)或心室颤动(VF)而有心脏性猝死风险的患者的一种疗法。但相对于诸如胺碘酮等抗心律失常药物而言,ICD疗法明显高昂的费用引发了关于ICD疗法与药物疗法相比成本效益如何的疑问。为了为这场辩论提供信息依据,我们查阅了有关ICD成本效益的文献。对自1980年以来发表的报告ICD与药物疗法对VT/VF风险患者成本效益的原始数据的文章进行了电子检索和手工检索。提取了成本和获得的生命年数的数据,并将研究分为使用决策分析模型的研究和基于试验的分析研究。成本效益比折算为2001年的美元。该综述纳入了9项研究;5项研究为建模研究,4项是ICD疗法随机试验的一部分。各研究的时间范围各不相同,但除一项研究外,所有研究均表明ICD疗法比药物疗法成本更高。早期决策模型假定的生存获益比随后试验中观察到的更大,因此具有诱人的增量成本效益比,每获得一个生命年在27000美元至60000美元的范围内。除一项小型试验外,基于试验的研究表明每获得一个生命年的成本在44000美元至144000美元的范围内。分层分析清楚地表明,因结构性心脏病导致死亡风险更高的患者(例如左心室射血分数≤35%)从ICD疗法中获益更多,因此其成本效益比相比低风险患者更具吸引力。随着时间的推移,ICD疗法仍在不断发展,植入成本在下降,设备技术在改进。目前的证据表明,在选定的VT/VF高风险患者中,ICD疗法可能是一种具有成本效益的选择。未来的研究应侧重于:(i)患者选择,以优化可用资源的获益;以及(ii)更全面的结局指标,包括与健康相关的生活质量。