Evidence & Access, OPEN Health, Rotterdam, The Netherlands.
Exact Sciences, Baar, Switzerland.
J Med Econ. 2024 Jan-Dec;27(1):445-454. doi: 10.1080/13696998.2024.2324612. Epub 2024 Mar 12.
Patients with early-stage hormone receptor positive, human epidermal growth factor receptor-2 (HER2) negative invasive breast cancer with 1-3 positive lymph nodes (N1) often undergo surgical excisions followed by adjuvant chemotherapy (ACT). Many patients have no benefit from ACT and receive unnecessary, costly treatment often associated with short- and long-term adverse events (AEs). Gene expression profiling (GEP) assays, such as the 21-gene assay (i.e. the Oncotype DX assay), can identify patients at higher risk for recurrence who may benefit from ACT. However, the budgetary consequence of using the Oncotype DX assay versus no GEP testing in the Netherlands is unknown. Our study therefore assessed it using a cost-consequence model.
A validated model was used to create the N1 model. The model compared the costs and consequences of using the Oncotype DX assay versus no GEP testing and MammaPrint, and subsequent ACT use with corresponding costs for chemotherapy, treatment of AEs, productivity losses, GEP testing, and treatment of recurrences, according to the Oncotype DX results. The model time horizon was 5 years.
Costs for the total population amounted to €8.0 million (M), €16.2 M, and €9.5 M, and cost per patient amounted to €13,540, €27,455, and €16,154 for using the Oncotype DX assay, no GEP testing, and MammaPrint, respectively. Total cost savings of using the Oncotype DX assay amounted to €8.2 M versus no GEP testing and €1.5 M versus MammaPrint. Using the Oncotype DX assay would result in fewer patients receiving ACT and thus fewer AEs, sick days, and hospitalizations, leading to overall cost savings compared with no GEP testing and MammaPrint.
Implementing Oncotype DX testing in this population can prevent unnecessary overtreatment, reducing clinical and economic burden on the patient and Dutch healthcare system.
患有早期激素受体阳性、人表皮生长因子受体-2（HER2）阴性、1-3 个阳性淋巴结（N1）的浸润性乳腺癌患者通常会接受手术切除，然后进行辅助化疗（ACT）。许多患者从 ACT 中获益甚微，却接受了不必要的、昂贵的治疗，而这些治疗往往与短期和长期不良事件（AE）相关。基因表达谱（GEP）检测，如 21 基因检测（即 Oncotype DX 检测），可以识别出复发风险较高的患者，他们可能从 ACT 中获益。然而，在荷兰，使用 Oncotype DX 检测与不进行 GEP 检测的预算后果尚不清楚。因此，我们使用成本-后果模型对其进行了评估。
使用验证过的模型创建了 N1 模型。该模型比较了使用 Oncotype DX 检测与不进行 GEP 检测和 MammaPrint 以及随后根据 Oncotype DX 结果使用 ACT 的成本和后果，相应的化疗成本、AE 治疗成本、生产力损失、GEP 检测成本以及治疗复发成本。模型时间范围为 5 年。
总人口的成本分别为 800 万欧元（M）、1620 万欧元和 950 万欧元，每位患者的成本分别为 13540 欧元、27455 欧元和 16154 欧元，分别使用 Oncotype DX 检测、不进行 GEP 检测和 MammaPrint。与不进行 GEP 检测相比，使用 Oncotype DX 检测可节省 820 万欧元，与 MammaPrint 相比可节省 150 万欧元。使用 Oncotype DX 检测可使接受 ACT 的患者减少，从而使 AEs、病假和住院治疗减少，与不进行 GEP 检测和 MammaPrint 相比，可节省总体成本。
在该人群中实施 Oncotype DX 检测可以防止不必要的过度治疗，减轻患者和荷兰医疗保健系统的临床和经济负担。
