AstraZeneca, Luton, Bedfordshire, United Kingdom.
Clin Ther. 2013 Mar;35(3):246-260.e5. doi: 10.1016/j.clinthera.2013.01.011. Epub 2013 Feb 28.
The goal of this study was to examine the cost-effectiveness of fulvestrant 500 mg for the treatment of first progression or recurrence of advanced breast cancer in postmenopausal patients compared with generic nonsteroidal aromatase inhibitors (anastrozole and letrozole) in the United Kingdom.
A cost-utility model based on a time-in-state approach was used. Clinical effectiveness estimates used in the model were derived from a network meta-analysis for overall survival and serious adverse events. Overall survival was extrapolated by using a Weibull distribution, and progression-free survival (PFS) estimates were derived from a simultaneous network meta-analysis and extrapolation of PFS curves by using the log-normal distribution. Data on resource use, costs, and utilities were based on various sources, including expert opinion and published data. To explore uncertainty, 1-way and probability sensitivity analyses were conducted. The study was conducted from the perspective of the UK National Health Service, and costs are reported in 2010/2011 British pounds.
The base case incremental cost-effectiveness ratio (ICER) for fulvestrant 500 mg versus letrozole was £34,528, with incremental costs of £14,383 and an incremental quality-adjusted life-year (QALY) of 0.417. Extended dominance occurred for anastrozole because the ICER for anastrozole versus letrozole was higher than the ICER for fulvestrant 500 mg versus anastrozole. Based on the probability sensitivity analyses, the probability that fulvestrant 500 mg was the most cost-effective treatment option was 3%, 20%, and 53% at a willingness-to-pay threshold of £20,000, £30,000, and £40,000 per QALY, respectively. According to the 1-way sensitivity analyses, the PFS estimates were the key drivers of the model results.
Although fulvestrant 500 mg was found not to be a cost-effective option at a standard UK threshold of £20,000 to £30,000 per QALY, it may be relevant to apply a higher threshold due to the poor prognosis of patients with advanced breast cancer and the limited number of hormonal treatment options available for this stage of treatment. Certain subgroups may also benefit from fulvestrant as a treatment option; however, limited data are currently available to identify these subgroups.
本研究旨在考察在英国，与非甾体芳香酶抑制剂（阿那曲唑和来曲唑）相比，氟维司群 500mg 治疗绝经后患者的晚期乳腺癌首次进展或复发的成本效益，评估其相对于通用药物的经济性。
采用基于状态时间的成本效用模型。模型中使用的临床效果评估数据源自网络荟萃分析的总生存期和严重不良事件数据。采用威布尔分布对总生存期进行外推，采用对数正态分布对无进展生存期（PFS）进行同时网络荟萃分析和 PFS 曲线外推。资源利用、成本和效用数据基于专家意见和已发表数据等多种来源。为了探索不确定性，进行了单因素敏感性分析和概率敏感性分析。本研究从英国国家医疗服务体系的角度进行，成本以 2010/2011 年英镑计价。
氟维司群 500mg 对比来曲唑的增量成本效果比（ICER）为 34528 英镑，增量成本为 14383 英镑，增量质量调整生命年（QALY）为 0.417。阿那曲唑具有扩展优势，因为阿那曲唑对比来曲唑的 ICER 高于氟维司群 500mg 对比阿那曲唑的 ICER。基于概率敏感性分析，在支付意愿阈值分别为 20000 英镑、30000 英镑和 40000 英镑/QALY 时，氟维司群 500mg 是最具成本效益治疗方案的概率分别为 3%、20%和 53%。根据单因素敏感性分析，PFS 估计是模型结果的关键驱动因素。
尽管氟维司群 500mg 按英国标准的 20000 英镑至 30000 英镑/QALY 进行评估，并非是一种具有成本效益的选择，但由于晚期乳腺癌患者的预后较差，以及该治疗阶段可选择的激素治疗方案有限，因此可能需要采用更高的阈值。某些亚组可能也将从氟维司群治疗中受益，但目前尚无足够数据来确定这些亚组。
