Cost effectiveness of recombinant factor VIIa for treatment of intracerebral hemorrhage.
Cost effectiveness of recombinant factor VIIa for treatment of intracerebral hemorrhage.
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DOI：
10.1186/1471-2377-8-17
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发表时间：
2008-05-19
期刊：
影响因子：
2.6
通讯作者：
Eckman MH
中科院分区：
文献类型：
--
作者：
Kissela BM;Eckman MH
重组凝血因子VIIa（rFVIIa）的I/II期安慰剂对照临床试验表明，在脑出血（ICH）发作后4小时内给予rFVIIa是安全的，可限制ICH的增长，并改善结局。我们试图使用已发表的II期数据确定rFVIIa治疗急性ICH的成本-效果。我们假设rFVIIa的边际成本-效果比（mCER）较低，因为ICH后常规治疗的神经功能结局较差。我们从社会角度进行了增量成本效益分析，考虑了符合II期纳入标准的急性ICH病例的常规治疗与80 ug/kg rFVIIa治疗。分析的时间范围为1。25年：II期试验的数据用于90天结局和rFVIIa并发症-动脉血栓栓塞事件（ATE）。我们假设两种策略之间的护理成本没有实质性差异，除了：1）rFVIIa的成本（对于80 kg患者的80 mcg/kg剂量，假设成本为6，408美元）; 2）rFVIIa的ATE副作用成本（这也降低了生活质量，增加了死亡的机会）;结果的不同货币成本及其对生活质量的影响，包括处置（家庭与疗养院），门诊与住院康复。进行敏感性分析，以探索参数估计值的不确定性、rFVIIa成本的影响、神经系统结局的直接成本、ATE的概率和ATE后的结局。在“基础病例”中，rFVIIa治疗ICH更有效，成本更低，是通常的治疗策略。在广泛的敏感性分析中，rFVIIa保持mCER <50，000美元/QALY。敏感性分析显示，rFVIIa的成本必须超过14，500美元，或ATE的频率超过29%，mCER才能超过50，000美元/QALY。改变成本和/或降低ATE后健康状态的效用不会影响结果。根据初步试验的数据，用rFVIIa治疗选定的ICH患者可降低成本并改善临床结局。必须根据III期试验结果考虑这种潜在的成本效益。
Phase I/II placebo-controlled clinical trials of recombinant Factor VIIa (rFVIIa) suggested that administration of rFVIIa within 4 hours after onset of intracerebral hemorrhage (ICH) is safe, limits ICH growth, and improves outcomes. We sought to determine the cost-effectiveness of rFVIIa for acute ICH treatment, using published Phase II data. We hypothesized that rFVIIa would have a low marginal cost-effectiveness ratio (mCER) given the poor neurologic outcomes after ICH with conventional management. We performed an incremental cost-effectiveness analysis from the societal perspective, considering conventional management vs. 80 ug/kg rFVIIa treatment for acute ICH cases meeting Phase II inclusion criteria. The time frame for the analysis was 1. 25 years: data from the Phase II trial was used for 90 day outcomes and rFVIIa complications – arterial thromboembolic events (ATE). We assumed no substantial cost differences in care between the two strategies except: 1) cost of rFVIIa (for an 80 mcg/kg dose in an 80 kg patient, assumed cost of $6,408); 2) cost of ATE side effects from rFVIIa (which also decrease quality of life and increase the chance of death); and 3) differential monetary costs of outcomes and their impact on quality of life, including disposition (home vs. nursing home), and outpatient vs. inpatient rehabilitation. Sensitivity analyses were performed to explore uncertainty in parameter estimates, impact of rFVIIa cost, direct cost of neurologic outcomes, probability of ATE, and outcomes after ATE. In the "base case", treating ICH with rFVIIa dominates the usual care strategy by being more effective and less costly. rFVIIa maintained a mCER < $50,000/QALY over a wide range of sensitivity analyses. Sensitivity analyses showed that the cost of rFVIIa must exceed $14,500, or the frequency of ATE exceed 29%, for the mCER to exceed $50,000/QALY. Varying the cost and/or reducing the utility of health states following ATE did not impact results. Based on data from preliminary trials, treating selected ICH patients with rFVIIa results in lower cost and improved clinical outcomes. This potential cost-effectiveness must be considered in light of the Phase III trial results.
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