氟维司群高剂量与低剂量方案治疗晚期乳腺癌的成本效用分析

Cost-utility Analysis of Fulvestrant High Dose Compared with Low Dose Regimen in Postmenopausal Women with Estrogen Receptor-positive Advanced Breast Cancer

目的:比较氟维司群500 mg和250 mg剂量方案用于既往内分泌治疗进展的雌激素受体阳性的绝经后女性晚期乳腺癌的二线治疗的成本效用,为医疗决策者提供参考。方法:基于三期临床试验CONFIRM的研究数据及中国医疗成本建立Markov模型。成本测算角度为中国全社会角度,效果指标为质量调整生命年(QALY),增量成本与增量效果的比值即为增量成本效果比(ICER)。意愿支付(WTP)阈值设定为3倍的中国人均GDP,即160 000元/QALY。结果:氟维司群500 mg和250 mg方案的总成本分别为221 829元和134 692元,其效果分别为1.16 QALYs和0.99 QALYs,计算得到ICER为512 571元/QALY,超出了WTP阈值。结论:在中国目前的经济形势下,氟维司群500 mg相比250 mg剂量方案不具有成本效果优势,但对于某些经济较发达地区,氟维司群500 mg可成为具成本效果的优势策略。

Objective： To evaluate the cost-utility of fulvestrant 500 mg regimen compared with the approved dose of fulvestrant 250 mg per month in treatment for postmenopausal women with estrogen receptor-positive advanced breast cancer who experienced progression after prior endocrine therapy. Methods： Markov model was constructed to assess the cost and effectiveness of fulvestrant 500 mg and 250 mg in treatment for advanced breast cancer. Clinical data were obtained from the phase Ⅲ clinical trial（CONFIRM）. Costs were estimated using micro-costing method from the Chinese societal perspective. The main outputs of the model included costs and quality-adjusted life year（QALY） which were used to determine the incremental cost-effectiveness ratio（ICER）. Willingness-to-pay threshold was set at $ 160 000/QALY. Robustness of the model was addressed in one-way analyses and probabilistic sensitivity analysis. Results： Fulvestrant 500 mg regimen provided an additional effectiveness gain of 1. 16 QALYs at an incremental cost of $ 221 829,while the 250 mg regimen yielded 0. 99 QALYs gain at an incremental cost of $ 134 692,resulting in an ICER of $ 512 571/QALY. Conclusion： Fulvestrant 500 mg regimen is not cost-effective compared with the 250 mg regimen in treatment of postmenopausal women with estrogen receptor-positive advanced breast cancer.