Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Implementing Oncotype DX testing in this population can prevent unnecessary overtreatment, reducing clinical and economic burden on the patient and Dutch healthcare system.
Early-stage invasive breast cancer patients often undergo surgery followed by adjuvant chemotherapy. However, many of these patients have no benefit from adjuvant chemotherapy and thus receive unnecessary and costly treatment often associated with side-effects. Patients who may benefit from adjuvant chemotherapy can be identified by analyzing the genomic profile of the patients’ tumors using a molecular diagnostic test called the 21-gene assay (also known as Oncotype DX assay). However, the budgetary consequences of using Oncotype DX for this purpose in the Netherlands are currently unknown and, therefore, assessed using a health-economic model. The model compared the costs and consequences of using the Oncotype DX assay versus no molecular diagnostic testing and an alternative molecular diagnostic test called MammaPrint. The three diagnostic testing strategies resulted in different costs in terms of several different costing categories and were compared with one another. The total costs were lowest for the diagnostic strategy using the Oncotype DX assay, as it would result in fewer patients receiving adjuvant chemotherapy compared with no molecular diagnostic testing and MammaPrint. Implementing the Oncotype DX assay as a molecular diagnostic test can identify the right patient who benefits from chemotherapy (prevent over- and undertreatment) and lead to cost-savings, reducing the clinical and economic burden on the patient and Dutch healthcare system.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Implementing Oncotype DX testing in this population can prevent unnecessary overtreatment, reducing clinical and economic burden on the patient and Dutch healthcare system.
Early-stage invasive breast cancer patients often undergo surgery followed by adjuvant chemotherapy. However, many of these patients have no benefit from adjuvant chemotherapy and thus receive unnecessary and costly treatment often associated with side-effects. Patients who may benefit from adjuvant chemotherapy can be identified by analyzing the genomic profile of the patients’ tumors using a molecular diagnostic test called the 21-gene assay (also known as Oncotype DX assay). However, the budgetary consequences of using Oncotype DX for this purpose in the Netherlands are currently unknown and, therefore, assessed using a health-economic model. The model compared the costs and consequences of using the Oncotype DX assay versus no molecular diagnostic testing and an alternative molecular diagnostic test called MammaPrint. The three diagnostic testing strategies resulted in different costs in terms of several different costing categories and were compared with one another. The total costs were lowest for the diagnostic strategy using the Oncotype DX assay, as it would result in fewer patients receiving adjuvant chemotherapy compared with no molecular diagnostic testing and MammaPrint. Implementing the Oncotype DX assay as a molecular diagnostic test can identify the right patient who benefits from chemotherapy (prevent over- and undertreatment) and lead to cost-savings, reducing the clinical and economic burden on the patient and Dutch healthcare system.
摘要：
背景：早期激素受体阳性的患者，人表皮生长因子受体-2(HER2)阴性浸润性乳腺癌,1~3个淋巴结(N1)阳性,常接受手术切除后辅助化疗(ACT).许多患者没有从ACT中获益，接受不必要的治疗，昂贵的治疗通常与短期和长期不良事件（AE）相关。基因表达谱分析（GEP）分析，例如21基因测定(即，OncotypeDX测定)，可以识别复发风险较高的患者，这些患者可能从ACT中受益。然而,在荷兰,使用OncotypeDX检测与不使用GEP检测的预算结果尚不清楚.因此，我们的研究使用成本-后果模型对其进行了评估。
方法：使用经验证的模型创建N1模型。该模型比较了使用OncotypeDX测定与不使用GEP测试和MammaPrint的成本和后果，以及随后的ACT使用以及相应的化疗费用，AE的治疗，生产力损失，GEP测试,和治疗复发，根据OncotypeDX结果。模型时间范围为五年。
结果：总人口的成本为800万欧元（M），€162万,和9.5万欧元，使用OncotypeDX测定法，每位患者的费用为13,540欧元，27,455欧元和16,154欧元，无GEP测试,还有MammaPrint,分别。使用OncotypeDX测定的总成本节省为820万欧元，与没有GEP测试相比为150万欧元，与MammaPrint相比为150万欧元。使用OncotypeDX分析将导致更少的患者接受ACT，从而更少的AE，生病的日子,和住院，与没有GEP测试和MammaPrint相比，可以节省总成本。
结论：在该人群中实施OncotypeDX测试可以防止不必要的过度治疗，减少患者和荷兰医疗保健系统的临床和经济负担。
早期浸润性乳腺癌患者通常在手术后进行辅助化疗。然而,这些患者中的许多患者没有从辅助化疗中获益，因此接受了通常与副作用相关的不必要且昂贵的治疗。可以通过使用称为21基因测定（也称为OncotypeDX测定）的分子诊断测试来分析患者肿瘤的基因组谱来鉴定可能受益于辅助化疗的患者。然而,在荷兰为此目的使用OncotypeDX的预算后果目前尚不清楚，因此，使用健康经济模型进行评估。该模型比较了使用OncotypeDX测定与没有分子诊断测试和称为MammaPrint的替代分子诊断测试的成本和后果。三种诊断测试策略在几种不同的成本类别方面产生了不同的成本，并进行了比较。使用OncotypeDX测定的诊断策略的总成本最低，因为与没有分子诊断测试和MammaPrint相比，这将导致接受辅助化疗的患者减少。实施OncotypeDX检测作为分子诊断测试可以识别从化疗中受益的正确患者（防止过度治疗和治疗不足）并节省成本。减少患者和荷兰医疗保健系统的临床和经济负担。
方法：使用经验证的模型创建N1模型。该模型比较了使用OncotypeDX测定与不使用GEP测试和MammaPrint的成本和后果，以及随后的ACT使用以及相应的化疗费用，AE的治疗，生产力损失，GEP测试,和治疗复发，根据OncotypeDX结果。模型时间范围为五年。
结果：总人口的成本为800万欧元（M），€162万,和9.5万欧元，使用OncotypeDX测定法，每位患者的费用为13,540欧元，27,455欧元和16,154欧元，无GEP测试,还有MammaPrint,分别。使用OncotypeDX测定的总成本节省为820万欧元，与没有GEP测试相比为150万欧元，与MammaPrint相比为150万欧元。使用OncotypeDX分析将导致更少的患者接受ACT，从而更少的AE，生病的日子,和住院，与没有GEP测试和MammaPrint相比，可以节省总成本。
结论：在该人群中实施OncotypeDX测试可以防止不必要的过度治疗，减少患者和荷兰医疗保健系统的临床和经济负担。
早期浸润性乳腺癌患者通常在手术后进行辅助化疗。然而,这些患者中的许多患者没有从辅助化疗中获益，因此接受了通常与副作用相关的不必要且昂贵的治疗。可以通过使用称为21基因测定（也称为OncotypeDX测定）的分子诊断测试来分析患者肿瘤的基因组谱来鉴定可能受益于辅助化疗的患者。然而,在荷兰为此目的使用OncotypeDX的预算后果目前尚不清楚，因此，使用健康经济模型进行评估。该模型比较了使用OncotypeDX测定与没有分子诊断测试和称为MammaPrint的替代分子诊断测试的成本和后果。三种诊断测试策略在几种不同的成本类别方面产生了不同的成本，并进行了比较。使用OncotypeDX测定的诊断策略的总成本最低，因为与没有分子诊断测试和MammaPrint相比，这将导致接受辅助化疗的患者减少。实施OncotypeDX检测作为分子诊断测试可以识别从化疗中受益的正确患者（防止过度治疗和治疗不足）并节省成本。减少患者和荷兰医疗保健系统的临床和经济负担。
