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替莫唑胺在新诊断的胶质母细胞瘤辅助治疗中的成本效益:美国的研究

The cost-effectiveness of temozolomide in the adjuvant treatment of newly diagnosed glioblastoma in the United States.

机构信息

Corresponding Author: Andrew Messali, PharmD, Leonard D. Schaeffer Center for Health Policy and Economics 3335 South Figueroa Street, Unit A Los Angeles, CA 90089-7273.

出版信息

Neuro Oncol. 2013 Nov;15(11):1532-42. doi: 10.1093/neuonc/not096. Epub 2013 Aug 9.

Abstract

BACKGROUND

The objective of this work was to determine the cost-effectiveness of temozolomide compared with that of radiotherapy alone in the adjuvant treatment of newly diagnosed glioblastoma. Temozolomide is the only chemotherapeutic agent to have demonstrated a significant survival benefit in a randomized clinical trial. Our analysis builds on earlier work by incorporating caregiver time costs and generic temozolomide availability. It is also the first analysis applicable to the US context.

METHODS

A systematic literature review was conducted to collect relevant data. Transition probabilities were calculated from randomized controlled trial data comparing temozolomide plus radiotherapy with radiotherapy alone. Direct costs were calculated from charges reported by the Mayo Clinic. Utilities were obtained from a previous cost-utility analysis. Using these data, a Markov model with a 1-month cycle length and 5-year time horizon was constructed.

RESULTS

The addition of brand Temodar and generic temozolomide to the standard radiotherapy regimen was associated with base-case incremental cost-effectiveness ratios of $102 364 and $8875, respectively, per quality-adjusted life-year. The model was most sensitive to the progression-free survival associated with the use of only radiotherapy.

CONCLUSIONS

Both the brand and generic base-case estimates are cost-effective under a willingness-to-pay threshold of $150 000 per quality-adjusted life-year. All 1-way sensitivity analyses produced incremental cost-effectiveness ratios below this threshold. We conclude that both the brand Temodar and generic temozolomide are cost-effective treatments for newly diagnosed glioblastoma within the US context. However, assuming that the generic product produces equivalent quality of life and survival benefits, it would be significantly more cost-effective than the brand option.

摘要

背景

本研究旨在评估替莫唑胺(temozolomide)联合放疗对比单纯放疗在新诊断胶质母细胞瘤辅助治疗中的成本效益。替莫唑胺是唯一一种在随机临床试验中显示出显著生存获益的化疗药物。我们的分析在早期工作的基础上,纳入了照料者时间成本和替莫唑胺通用药物的可获得性。此外,这也是首个适用于美国情况的分析。

方法

我们进行了系统文献回顾,以收集相关数据。从比较替莫唑胺联合放疗与单纯放疗的随机对照试验数据中计算转移概率。直接成本根据梅奥诊所(Mayo Clinic)报告的收费计算。效用值从前瞻性成本效益分析中获得。利用这些数据,我们构建了一个具有 1 个月周期和 5 年时间范围的 Markov 模型。

结果

与标准放疗方案相比,添加品牌 Temodar 和通用替莫唑胺的增量成本效益比分别为 102364 美元和 8875 美元/质量调整生命年。该模型对仅放疗相关的无进展生存期最为敏感。

结论

在 150000 美元/QALY 的意愿支付阈值下,品牌和通用的基础情况估计均具有成本效益。所有单向敏感性分析的增量成本效益比均低于该阈值。我们的结论是,在考虑到品牌 Temodar 和通用替莫唑胺的成本效益比的情况下,这两种药物均为美国新诊断胶质母细胞瘤的有效治疗选择。然而,假设通用药物在质量和生存获益方面与品牌药物相当,那么它的成本效益将明显更高。

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