用二十一基因检测减少乳腺癌人群辅助化疗或得不偿失
对于已接受内分泌治疗的激素受体阳性乳腺癌患者，昂贵的21基因检测有助于决定是否需要再接受昂贵且不良反应较多的化疗。支持进行21基因检测的经济学研究，使用了假设的决策分析模型，其数据来源不同。
2018年1月20日，美国临床肿瘤学会《临床肿瘤学杂志》将正式发表加拿大多伦多大学、安大略省癌症治疗中心、森尼布鲁克研究所、医疗结局与药物经济学研究中心、安大略省癌症研究所、安大略省临床评价科学研究所、麦克马斯特大学、朱拉文斯基癌症中心、安大略省临床肿瘤学组的人群研究报告，对21基因检测是否可致医疗系统总成本增加或节省进行了评价。
该现场评价研究于2012年1月1日～2013年7月31日入组激素受体阳性早期浸润性乳腺癌术后患者1000例，与人群医疗系统管理数据库进行关联，并观察20个月，确定该队列的成本，其中包括21基因检测、随后接受治疗、医疗就诊的成本。将未检测与化疗前接受21基因检测的辅助化疗不同使用情况进行比较，计算了医疗系统总成本和增量成本。
结果发现，21基因检测使化疗净减少23%。根据增量分析，该队列的医疗系统实际总成本（包括21基因检测成本）为2920万美元，未检测为2620万美元，相比之下增加了310万美元。根据四种情景分析，其中三种情景的医疗系统实际总成本超过未检测的估算成本。结果表明，当至少一半人群接受辅助化疗时，成本增加到3020万美元。
因此，根据真实世界的医疗管理数据表明，虽然化疗的使用减少，但是根据大多数情况，21基因检测引起短期医疗系统总成本增加。
J Clin Oncol. 2018 Jan 20;36(3):238-243.
Population-Based Study to Determine the Health System Costs of Using the 21-Gene Assay.
Mittmann N, Earle CC, Cheng SY, Julian JA, Rahman F, Seung SJ, Levine MN.
Sunnybrook Research Institute, Cancer Care Ontario, University of Toronto; Ontario Institute for Cancer Research; Institute for Clinical Evaluative Sciences; Health Outcomes and PharmacoEconomic (HOPE) Research Centre, Sunnybrook Research Institute, Toronto; Juravinski Cancer Centre, McMaster University, Ontario Clinical Oncology Group, Hamilton, Ontario, Canada.
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.
PMID: 29193984
DOI: 10.1200/JCO.2017.74.2577