Purpose The 21-gene assay Oncotype Dx (Genomic Health, Redwood City, CA) test is used to aid the decision about chemotherapy in patients with hormone receptor-positive breast cancer who received endocrine therapy. Economic studies to support test adoption used decision-analytic models with assumptions and data derived from disparate sources. The objective was to evaluate whether the 21-gene assay test resulted in an overall cost expense or saving to the health system. Patients and Methods One thousand participants enrolled in a field evaluation study, were linked to population-level health system administrative databases, and were observed for 20 months. The cost for the cohort, which included the cost of the test, subsequent treatments received, and health care encounters, was determined. The cost in the absence of the test was compared with the pretest recommendation about chemotherapy from the field study for a base case and under scenarios that reflected different adjuvant chemotherapy use. Overall health system costs and incremental costs were calculated. Results The 21-gene assay resulted in a net decrease in chemotherapy use of 23%. For the base case incremental analysis, the actual overall health system cost of this cohort, including the cost of 21-gene assay, was $29.2 million compared with $26.2 million in the absence of the test-an increase of $3.1 million. For three of the four scenario analyses, the actual overall cost to the health system exceeded the estimated cost in the absence of the test. Results showed that, when at least half of the population received adjuvant chemotherapy, the cost increased to $30.2 million. Conclusion The use of real-world administrative data showed that, despite lower rates of chemotherapy use, the 21-gene assay test results in an overall incremental cost to the health care system in the short-term under most assumptions.

中文翻译：

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确定使用 21 基因检测的卫生系统成本的基于人群的研究

目的 21 基因检测 Oncotype Dx（Genomic Health，Redwood City，CA）测试用于帮助接受内分泌治疗的激素受体阳性乳腺癌患者决定是否接受化疗。支持测试采用的经济研究使用决策分析模型，其中包含来自不同来源的假设和数据。目的是评估 21 基因检测测试是否会导致整体成本支出或卫生系统的节省。患者和方法 1000 名参与者参加了一项实地评估研究，与人口级别的卫生系统管理数据库相关联，并观察了 20 个月。确定了队列的成本，包括测试成本、接受的后续治疗和医疗保健。在没有测试的情况下，将成本与来自实地研究的关于化学疗法的预测试建议进行比较，用于基本案例和反映不同辅助化疗使用的情景。计算了整体卫生系统成本和增量成本。结果 21 基因检测导致化疗使用净减少 23%。对于基本案例增量分析，该队列的实际整体卫生系统成本（包括 21 基因检测的成本）为 2920 万美元，而在没有检测的情况下为 2620 万美元，增加了 310 万美元。对于四个情景分析中的三个，卫生系统的实际总成本超过了在没有测试的情况下的估计成本。结果显示，当至少一半人口接受辅助化疗时，成本增加到 3020 万美元。