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首页> 外文期刊>Investigative ophthalmology & visual science >A Cost-Effectiveness Analysis of the Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema
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A Cost-Effectiveness Analysis of the Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema

机译：随机试验评估Ranibizumab加提示或延缓激光或曲安西龙加提示激光治疗糖尿病性黄斑水肿的成本-效果分析

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Purpose: : The costs of new treatment strategies for diabetic macular edema (DME) have the potential to add millions of dollars to the health care system; therefore, policymakers need to determine if this cost is justified by the effectiveness of treatment. We present a cost-effectiveness analysis (CEA) of the four strategies evaluated in a recent randomized clinical trial (Protocol I). Methods: : We constructed a Markov model to replicate Protocol I using a microsimulation approach to estimation. The Markov cycle was one month, the model duration was one year (based on the time to primary outcome in Protocol I), and we took the payora??s perspective. We based the clinical pathway on the management algorithms outlined in Protocol I. Subjects were assigned initial characteristics of visual acuity (VA) and macular thickness (OCT) based upon the participants in the clinical trial. The simulated participants accrued costs upon cycle completion, and changes in VA and OCT were assigned based upon the effectiveness in the designated treatment arm. Treatment complications were also based upon the clinical trial experience. Cost information was obtained via literature search and from the Barnes Retina Institute billing department. We present cost, effectiveness as measured by change in letters correct, and the incremental cost-effectiveness ratio (ICER). The modela??s internal validity was established by comparison to Protocol I outcomes. Results: : Preliminary data gives expected values for groups 1 (laser), 2 (ranibizumab plus prompt laser), 3 (ranibizumab plus deferred laser), and 4 (steroid plus laser). Expected costs in groups 1-4 were $3,232, $21,200, $22,623, and $3,785, respectively. The expected effectiveness values in groups 1-4 were 4, 7.4, 8.5, and 4 letters gained, respectively. ICER values in terms of dollars per VA letter were 21,944 (4 vs 1), 5,169 (2 vs 4), and 1,318 (3 vs 2). Similar ICER values calculated for pseudophakic subgroups were 39 (4 vs 1), -13,913 (3 vs 4), and 29 (2 vs 3). Conclusions: : The use of ranibizumab in treatment of DME results in an increase on nearly one line of vision over laser alone, or laser plus steroids; however, policymakers must also be aware that there is substantial cost to gain this improvement. Further analysis concerning important subgroups might improve our understanding of those who might most benefit from this therapy.
机译：目的：糖尿病黄斑水肿（DME）新治疗策略的成本有可能为卫生保健系统增加数百万美元的潜力;因此，决策者需要确定这种费用是否因治疗的有效性而合理。我们在最近的一项随机临床试验（方案I）中评估了四种策略的成本效益分析（CEA）。方法：我们建立了一个马尔可夫模型，使用微观模拟方法来复制协议I。马尔可夫周期是一个月，模型持续时间是一年（基于第一议定书中取得主要成果的时间），我们采用了payora的观点。我们根据协议I中概述的管理算法建立临床路径。根据临床试验的参与者，为受试者分配了视敏度（VA）和黄斑厚度（OCT）的初始特征。模拟参与者在周期结束时应计费用，并根据指定治疗组的有效性分配VA和OCT的变化。治疗并发症也基于临床试验经验。成本信息是通过文献搜索和Barnes Retina Institute计费部门获得的。我们介绍了成本，通过正确更改字母来衡量的有效性以及增量成本效益比（ICER）。模型的内部有效性是通过与协议I的结果进行比较来确定的。结果：：初步数据给出了第1组（激光），第2组（ranibizumab加快速激光），第3组（ranibizumab加延迟激光）和第4组（类固醇加激光）的期望值。第1-4组的预期费用分别为$ 3,232，$ 21,200，$ 22,623和$ 3,785。第1-4组的预期有效性值分别为4、7.4、8.5和4个字母。以每VA字母美元计的ICER值分别为21,944（4比1），5,169（2比4）和1,318（3比2）。为假晶状体亚组计算的相似ICER值分别为39（4对1），-13,913（3对4）和29（2对3）。结论：雷尼单抗治疗DME比单用激光或激光加类固醇可增加近一个视线。但是，决策者还必须意识到，要实现这一改进需要付出巨大的代价。有关重要亚组的进一步分析可能会增进我们对可能从该疗法中受益最大的人群的了解。

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