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基因表达谱分析在早期乳腺癌中的成本效益:决策分析模型。

Cost effectiveness of gene expression profiling for early stage breast cancer: a decision-analytic model.

机构信息

Program in Personalized Medicine and Targeted Therapeutics, University of the Sciences, Philadelphia, PA 19104, USA.

出版信息

Cancer. 2012 Oct 15;118(20):5163-70. doi: 10.1002/cncr.27443. Epub 2012 Feb 22.

Abstract

BACKGROUND

Gene expression profiling (GEP) is being used increasingly for risk stratification to identify women with lymph node-negative, estrogen receptor-positive, early stage breast cancer who are most likely to benefit from adjuvant chemotherapy. The authors of this report evaluated the cost effectiveness of recurrence score-guided treatment using 2 commercially available GEP tests, Oncotype DX (Genomic Health, Redwood City, Calif) and MammaPrint (Agendia Inc., Irvine, Calif), from a third-party payer's perspective.

METHODS

A 10-year Markov model was developed to compare the costs and quality-adjusted life-years (QALYs) of treatment decisions guided by either Oncotype DX or MammaPrint in a hypothetical cohort of women with early stage, lymph node-negative, estrogen receptor-positive breast cancer who may experience recurrence. Outcomes included no recurrence, recurrence, and death. The costs considered included gene test costs, the costs of adjuvant chemotherapy and other chemotherapy (including premedication, oncology visits, and monitoring for adverse events), the cost of treating recurrence, costs associated with the treatment of adverse events, and end-of-life care costs.

RESULTS

The model demonstrated that the patients who received the Oncotype DX test to guide treatment spent $27,882 (in US dollars) and gained 7.364 QALYs, whereas patients who received the MammaPrint test to guide treatment spent $21,598 and gained 7.461 QALYs. Sensitivity analyses demonstrated that the results were robust to changes in all parameters.

CONCLUSIONS

The model suggested that MammaPrint is a more cost-effective GEP test compared with Oncotype DX at a threshold willingness-to-pay of $50,000 per QALY. Because Oncotype DX is the most frequently used GEP in clinical practice in the United States, the authors concluded that the current findings have implications for health policy, particularly health insurance reimbursement decisions.

摘要

背景

基因表达谱(GEP)分析越来越多地用于风险分层,以确定淋巴结阴性、雌激素受体阳性、早期乳腺癌患者中最有可能从辅助化疗中获益的人群。本报告的作者从第三方支付者的角度评估了两种商业上可用的 GEP 检测(Oncotype DX [Genomic Health,加利福尼亚州雷德伍德市]和 MammaPrint [Agendia Inc.,加利福尼亚州欧文市])指导下的复发评分指导治疗的成本效益。

方法

开发了一个 10 年的 Markov 模型,以比较在可能发生复发的淋巴结阴性、雌激素受体阳性早期乳腺癌女性的假设队列中,基于 Oncotype DX 或 MammaPrint 的治疗决策的成本和质量调整生命年(QALY)。结果包括无复发、复发和死亡。考虑的成本包括基因检测成本、辅助化疗和其他化疗(包括预处理、肿瘤就诊和监测不良事件)成本、复发治疗成本、与不良事件治疗相关的成本以及生命终末期护理成本。

结果

该模型表明,接受 Oncotype DX 检测指导治疗的患者花费 27882 美元(以美元计)并获得 7.364 QALY,而接受 MammaPrint 检测指导治疗的患者花费 21598 美元并获得 7.461 QALY。敏感性分析表明,结果对所有参数的变化均具有稳健性。

结论

该模型表明,在 50000 美元/QALY 的意愿支付阈值下,与 Oncotype DX 相比,MammaPrint 是一种更具成本效益的 GEP 检测。由于 Oncotype DX 是美国临床实践中最常使用的 GEP,作者得出结论,这些发现对卫生政策,特别是健康保险报销决策具有重要意义。

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