Partnership for Health Analytic Research, Beverly Hills, CA 90212, USA.
Am J Manag Care. 2011;17(7):455-64.
To assess impact on health outcomes and healthcare expenditures of adopting a 21-gene assay for women with early-stage, minimally node-positive, estrogen receptor-positive (N (1-3)/ER) HER2-negative breast cancer.
We adapted a deterministic decision-analytic model to estimate costs and quality-of-life outcomes associated with chemotherapy, adverse events, supportive care, recurrence, and second primary cancers for usual care compared with care determined by the 21-gene assay recurrence score, where 71% and 54% of women, respectively, were treated with adjuvant chemotherapy. Model input data were based on national statistics, published literature, physician surveys, and Medicare Part B prices.
Annual numbers of events were multiplied by quality-adjusted life-years (QALYs) lost and costs to estimate net health and economic impacts of each strategy. Analyses were from a managed care payer perspective for the US population.
Patients receiving the assay were predicted to gain 0.127 QALY and save $4359 annually from avoiding chemotherapy, adverse events, supportive care, and secondary primary tumors. For a 2-million member plan, net gains were 4.44 QALYs/year and savings were $13,476/year. Cost savings were greater for the Medicare population. Although overall results were sensitive only to reduced impact of testing and chemotherapy costs, they were still highly cost-effective (incremental cost-effectiveness ratio <$20,000/QALY).
Use of a 21-gene assay in patients with early-stage N (1-3)/ER HER2-negative breast cancer may improve health outcomes and add no incremental cost, thereby providing valuable insight for health plans, the Centers for Medicare and Medicaid Services, and clinicians regarding coverage policies and treatment decisions.
评估采用 21 基因检测对早期、淋巴结转移 1-3 个且雌激素受体阳性（N（1-3）/ER）、HER2 阴性乳腺癌患者的健康结局和医疗支出的影响。
我们改编了一个确定性决策分析模型，以评估与化疗、不良反应事件、支持性护理、复发和第二原发癌相关的成本和生活质量结果，比较了常规护理和 21 基因检测复发评分决定的护理，分别有 71%和 54%的女性接受辅助化疗。模型输入数据基于国家统计数据、已发表文献、医生调查和医疗保险 B 部分价格。
每年事件的数量乘以丧失的质量调整生命年（QALY）和成本，以估计每种策略的净健康和经济影响。分析基于美国管理式医疗支付者的角度。
预计接受检测的患者通过避免化疗、不良反应事件、支持性护理和第二原发肿瘤，每年可增加 0.127 个 QALY 并节省 4359 美元。对于一个 200 万成员的计划，每年净增益为 4.44 QALY/年，节省 13476 美元/年。医疗保险人群的成本节约更大。尽管总体结果仅对检测和化疗成本的影响降低敏感，但它们仍然具有高度成本效益（增量成本效益比<20000 美元/QALY）。
在早期 N（1-3）/ER HER2 阴性乳腺癌患者中使用 21 基因检测可能改善健康结局且不增加额外成本，从而为健康计划、医疗保险和医疗补助服务中心以及临床医生提供有关覆盖政策和治疗决策的宝贵见解。
