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地舒单抗对比唑来膦酸在乳腺癌伴骨转移患者中的成本效果分析。

Cost-effectiveness of denosumab compared with zoledronic acid in patients with breast cancer and bone metastases.

机构信息

Analysis Group, Inc, New York, NY 10020, USA.

出版信息

Clin Breast Cancer. 2012 Aug;12(4):247-58. doi: 10.1016/j.clbc.2012.04.001. Epub 2012 Jun 12.

DOI:10.1016/j.clbc.2012.04.001
PMID:22694824
Abstract

BACKGROUND

Results from a phase III clinical trial showed that denosumab significantly reduced the risk of first on-study and subsequent skeletal-related events (SREs) compared with zoledronic acid. This study aims to assess the cost-effectiveness of denosumab vs. zoledronic acid in the prevention of SREs in patients with advanced breast cancer and bone metastases.

MATERIALS AND METHODS

A Markov model was developed with 4-week model cycles and a 1-year time horizon. The health states were defined by SRE status (no SRE, first on-study SRE, subsequent SRE, no SRE but history of SRE) and SRE type (pathologic fracture, radiation to the bone, surgery to the bone, spinal cord compression). Costs (in 2011 US dollars) included drug, SRE treatment, and adverse event (AE) costs and were assessed from a third-party payer perspective. The primary outcome was incremental total cost per SRE avoided; the secondary outcome was incremental total cost per pathologic fracture avoided. One-way and probabilistic sensitivity analyses were used to assess the robustness of the model.

RESULTS

During the 1-year treatment period, denosumab incurred $7522 higher costs ($30,033 for denosumab and $23,511 for zoledronic acid), 0.06 fewer SREs, and 0.02 fewer pathologic fractures per patient, which led to an incremental total cost per SRE and pathologic fracture avoided of $114,628 and $290,136, respectively, compared with zoledronic acid. Results were robust to 1-way and probabilistic sensitivity analyses.

CONCLUSION

Although denosumab demonstrated superiority in preventing SREs in the phase III trial, it may not be cost-effective compared with zoledronic acid because of its high cost.

摘要

背景

一项 III 期临床试验结果表明,与唑来膦酸相比,地舒单抗显著降低了首次研究期间和随后的骨骼相关事件(SRE)的风险。本研究旨在评估地舒单抗与唑来膦酸预防晚期乳腺癌和骨转移患者 SRE 的成本效益。

材料与方法

采用 Markov 模型,模型周期为 4 周,时间范围为 1 年。健康状态由 SRE 状态(无 SRE、首次研究期间 SRE、随后 SRE、无 SRE 但有 SRE 史)和 SRE 类型(病理性骨折、骨放疗、骨手术、脊髓压迫)定义。成本(以 2011 年美元计)包括药物、SRE 治疗和不良事件(AE)成本,从第三方支付者的角度进行评估。主要结果是每避免一次 SRE 增加的总成本;次要结果是每避免一次病理性骨折增加的总成本。采用单因素和概率敏感性分析评估模型的稳健性。

结果

在 1 年的治疗期间,地舒单抗的成本增加了 7522 美元(地舒单抗为 30033 美元,唑来膦酸为 23511 美元),SRE 减少 0.06 次,病理性骨折减少 0.02 次/患者,与唑来膦酸相比,每避免一次 SRE 和病理性骨折的总成本分别增加了 114628 美元和 290136 美元。结果对单因素和概率敏感性分析均稳健。

结论

尽管地舒单抗在 III 期试验中显示出在预防 SRE 方面的优势,但由于其高成本,与唑来膦酸相比,它可能不具有成本效益。

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