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依匹单抗二线治疗晚期黑色素瘤患者的成本效益分析。

Ipilimumab in 2nd line treatment of patients with advanced melanoma: a cost-effectiveness analysis.

机构信息

IMS Health Economics and Outcomes Research, 210 Pentonville Road, London, UK.

出版信息

J Med Econ. 2013;16(2):202-12. doi: 10.3111/13696998.2012.739226. Epub 2012 Nov 1.

Abstract

OBJECTIVE

To estimate the cost-effectiveness of ipilimumab (3 mg/kg) compared with best supportive care (BSC) in pre-treated advanced melanoma patients.

METHODS

The analysis was based on a US payer perspective and lifetime time horizon. A three-state Markov model was developed representing clinical outcomes, quality-of-life, and healthcare resource use of patients treated with ipilimumab and BSC. Transitions between states were modeled using overall and progression-free survival data from the MDX010-20 trial. Utility data were from a melanoma-specific study of the health state preferences of the general population. Disease management costs expressed in 2011 US Dollars were based on healthcare resource use observed in a US retrospective medical chart study. Uncertainty was analyzed using one-way and probabilistic sensitivity analyses.

RESULTS

The gain in life years and QALYs from introducing ipilimumab over BSC were 1.88 years (95% CI = 1.62-2.20) and 1.14 (95% CI = 1.01-1.34) QALYs, respectively, over the lifetime time horizon. The estimated incremental cost of treating with ipilimumab vs BSC was $146,716 (95% CI = $130,992-$164,025). The estimated incremental cost-effectiveness ratios were $78,218 per life year gained and $128,656 per QALY gained. Ipilimumab was 95% likely to be cost-effective at a willingness-to-pay of $146,000/QALY.

LIMITATIONS

Ipilimumab's method of action causes a tumor response pattern that differs from the Response Evaluation Criteria in Solid Tumors upon which the model is based, leading to a potential under-estimate of quality-of-life of ipilimumab patients. Survival and QALY gains were related to the time horizon of the analysis. Sensitivity analyses indicated that qualitative conclusions regarding the cost-effectiveness of ipilimumab were unchanged when the method of quality adjustment and the time horizon were varied.

CONCLUSION

The analysis shows that the estimated cost-effectiveness of ipilimumab is within what has been shown to be acceptable to payers for oncology products in the US.

摘要

目的

评估依匹单抗(3mg/kg)与最佳支持治疗(BSC)相比在预处理的晚期黑色素瘤患者中的成本效益。

方法

分析基于美国支付方视角和终生时间范围。建立了一个三状态 Markov 模型,代表接受依匹单抗和 BSC 治疗的患者的临床结果、生活质量和医疗资源使用情况。使用来自 MDX010-20 试验的总生存期和无进展生存期数据对状态间的转换进行建模。效用数据来自一般人群对健康状态偏好的黑色素瘤特定研究。以 2011 年美元表示的疾病管理成本基于美国回顾性医疗图表研究中观察到的医疗资源使用情况。使用单因素敏感性分析和概率敏感性分析对不确定性进行分析。

结果

与 BSC 相比,引入依匹单抗可获得 1.88 年(95%CI=1.62-2.20)和 1.14 年(95%CI=1.01-1.34)的生命年和 QALY,在终生时间范围内。与 BSC 相比,用依匹单抗治疗的估计增量成本为 146716 美元(95%CI=130992-164025)。估计的增量成本效益比为每获得 1 个生命年需花费 78218 美元,每获得 1 个 QALY 需花费 128656 美元。依匹单抗在愿意支付 146000 美元/QALY 的情况下有 95%的可能性是具有成本效益的。

局限性

依匹单抗的作用方式导致其肿瘤反应模式与模型所依据的实体瘤反应评价标准不同,这可能导致对依匹单抗患者生活质量的低估。生存和 QALY 获益与分析的时间范围有关。敏感性分析表明,当调整质量的方法和时间范围发生变化时,关于依匹单抗成本效益的定性结论保持不变。

结论

分析表明,依匹单抗的估计成本效益在美国被认为是可接受的肿瘤产品支付方。

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