阿贝西利联合氟维司群二线治疗激素受体阳性的晚期乳腺癌的药物经济学评价

目的 从中国卫生体系角度评价阿贝西利联合氟维司群对比单用氟维司群二线治疗激素受体(hormone receptor，HR)阳性的晚期乳腺癌的经济性。方法 利用MONARCH 2临床试验公布的生存数据及相关成本和效用数据构建分区生存模型，模型循环周期设为4周，模拟时限为20年，贴现率设为5%。模型的产出指标为成本和质量调整生命年(quality-adjusted life year，QALY)，模型评价指标为增量成本-效果比(incremental cost-effectiveness ratio，ICER)。意愿支付阈值(willingness-to-pay threshold，WTP)为2021年中国1~3倍人均GDP(80 976元/QALY~242 928元/QALY)。进行不确定性分析以评价模型结果的稳健性。结果 基础分析结果显示，阿贝西利联合氟维司群同单用氟维司群相比可带来更多的健康获益，但同时总成本更高。增量效用及增量成本分别0.88 QALYs和306 014.57元，两方案相比的ICER值为348 507.45元/QALY。不确定性分析证实了模型结果具有稳健性。当阿贝西利价格降低70%时，阿贝西利联合氟维司群在中国3倍人均GDP下具有经济性的概率>50%。结论 阿贝西利联合氟维司群同单用氟维司群相比在二线治疗HR阳性的晚期乳腺癌患者时不具有成本-效果优势，但在北京、上海等较发达地区，阿贝西利联合氟维司群具有经济学优势。

Pharmacoeconomic Evaluation of Abemaciclib in Combination with Fulvestrant for Second-line Treatment of Hormone Receptor-positive Advanced Breast Cancer

OBJECTIVE To evaluate the economics of abemaciclib combined with fulvestrant compared with single use of fulvestrant in the second-line treatment of hormone receptor(HR)-positive advanced breast cancer from the perspective of Chinese health-care system. METHODS A partitioned survival model was conducted by using the survival data published from the MONARCH 2 clinical trial and associated cost and utility data. The cycle length of the model was 4 weeks and the time horizon of the model was set to 20 years, the discount rate was 5%. The output indicators of the model were cost and quality-adjusted life year (QALY), and the evaluation indicator of the model was incremental cost-effectiveness ratio(ICER). The willingness-to-pay threshold(WTP) was 1-3 times per capita GDP(￥80 976/QALY-￥242 928/QALY) in China in 2021. Uncertainty analyses were performed to evaluate the robustness of the model results. RESULTS The results of the base-case analyses showed that abemaciclib combined with fulvestrant could bring more health benefits than single use of fulvestrant, but at the same time, the total cost was higher. The incremental QALYs and incremental costs were 0.88 QALYs and ￥306 014.57, respectively, resulting the ICER were ￥348 507.45/QALY. The uncertainty analyses confirmed the robustness of the model results. When the price of abemaciclib reduced 70%, the probability of abemaciclib combined with fulvestrant being cost-effective was more than 50% under the 3 times per capita GDP in China. CONCLUSION Abemaciclib combined with fulvestrant do not have a cost-effective advantage over single use of fulvestrant in second-line treatment of HR-positive advanced breast cancer. However, in more developed regions such as Beijing, Shanghai, abemaciclib combined with fulvestrant has economic advantages.