Cedar Associates, Menlo Park; Stanford University School of Medicine, Stanford, CA; Humana, Louisville, KY.
J Oncol Pract. 2011 May;7(3 Suppl):e38s-45s. doi: 10.1200/JOP.2011.000303.
National guidelines recommend a 21-gene recurrence score (RS) to aid in adjuvant treatment decision in patients with estrogen receptor (ER) -positive, lymph node (LN) -negative early-stage breast cancer (ESBC). This study was performed to assess the economic implication of the assay in community practices from the perspective of a US payer.
The study analyzed 952 women with ESBC enrolled with Humana (Louisville, KY) who were tested with the 21-gene RS between June 2006 and June 2010. The proportion of women classified by the assay according to RS risk category, use, and costs of chemotherapy regimens and supportive care, and costs of adverse events were obtained from Humana. We adopted a validated Markov model to compute the cost implications of RS for a representative patient. The probability of risk of recurrence, the chemotherapy benefit, and the decision impact of RS were derived from published studies.
Two hundred fifty-five patients within the tested population received adjuvant chemotherapy. Adjuvant chemotherapy was administered to 10% of women at low risk, 36% of women at intermediate risk, and 72% of women at high risk of recurrence. On the basis of a meta-analysis in the reduction of chemotherapy after RS, the model estimated an average test saving of $1,160 per patient. The immediate direct savings for chemotherapy drugs, supportive care, and management of adverse events were $1,885, $2,578, and $472, respectively. Prevention of recurrence through appropriate treatment of patients at high risk resulted in additional savings of $199.
The adoption of the 21-gene RS led to targeted management of women with ER-positive, LN-negative ESBC and consequently directed savings to the payer.
国家指南建议使用 21 基因复发评分（RS）来辅助决策是否对雌激素受体（ER）阳性、淋巴结（LN）阴性的早期乳腺癌（ESBC）患者进行辅助治疗。本研究旨在从美国支付方的角度评估该检测在社区实践中的经济意义。
该研究分析了 2006 年 6 月至 2010 年 6 月期间，接受 Humana（肯塔基州路易斯维尔）入组并接受 21 基因 RS 检测的 952 例 ESBC 女性患者。从 Humana 获得了根据 RS 风险类别、使用情况以及化疗方案和支持性护理的成本、不良事件的成本对女性进行分类的比例。我们采用了经过验证的 Markov 模型来计算 RS 对代表性患者的成本影响。风险复发概率、化疗获益和 RS 的决策影响均来自已发表的研究。
在测试人群中，有 255 名患者接受了辅助化疗。低危患者中有 10%、中危患者中有 36%、高危患者中有 72%接受了辅助化疗。基于 RS 降低化疗风险的荟萃分析，该模型估计每位患者的平均检测节省 1160 美元。化疗药物、支持性护理和不良事件管理的直接即时节省分别为 1885 美元、2578 美元和 472 美元。通过对高危患者进行适当治疗来预防复发，还额外节省了 199 美元。
采用 21 基因 RS 导致了对 ER 阳性、LN 阴性 ESBC 患者的靶向管理，并因此为支付方带来了节省。
