瑞维鲁胺治疗高瘤负荷转移性激素敏感性前列腺癌的成本-效用分析

Cost-utility analysis of rezvilutamide for high-volume metastatic hormone sensitive prostate cancer

目的:评估瑞维鲁胺相较阿帕他胺,治疗中国高瘤负荷的转移性激素敏感性前列腺癌(metastatic hormone-sensitive prostate cancer,mHSPC)的经济性,为前列腺癌临床用药选择提供药物经济性证据。方法:基于分区生存模型开展成本-效用分析,分别使用无影像学进展和无血清前列腺特异性抗原(prostate-specific antigen,PSA)进展分析无进展生存期,结合总生存期获得临床疗效数据。临床、效用和成本参数来源于药物关键临床试验、已发表文献和市场调研。最终计算在1倍人均GDP下瑞维鲁胺治疗高瘤负荷mHSPC的成本-效果。结果:基础分析结果显示,瑞维鲁胺较阿帕他胺治疗高瘤负荷mHSPC可增加患者1.31质量调整生命年(QALYs),伴随75387元成本增加,增量成本-效果比为57565元/QALY,小于中国1倍人均GDP。当成本-效果阈值为1倍人均GDP时,瑞维鲁胺相比阿帕他胺更具经济性的概率为60.1%。若以无血清PSA进展为无进展生存期开展情境分析,瑞维鲁胺较阿帕他胺更具经济性优势。结论:对于中国高瘤负荷mHSPC患者,瑞维鲁胺相比阿帕他胺具有经济性。

OBJECTIVE To evaluate the cost-effectiveness of rezvilutamide versus apalutamide for high-volume metastatic hormone-sensitive prostate cancer(mHSPC)for Chinese patients and to provide economic rationales for clinical use of drugs.METHODS Cost-utility analysis was performed with a partitioned survival model.Progression-free survival(PFS)was exam⁃ined by radiographic progression-free survival(rPFS)and serum progression-free prostate-specific antigen(PSA)progression.Also overall survival(OS)was analyzed.All clinical,utility and cost parameters were derived from clinical trials,published litera⁃tures and market surveys.Finally the cost-effectiveness of rezvilutamide for high-volume mHSPC was calculated under a thresh⁃old of one-time gross domestic product per capita in China[GDP(85698 yuan,2022)].RESULTS The results of base-case analysis indicated that,as compared with apalutamide,rezvilutamide resulted in a lifetime cost to the Chinese health care system of¥75387 per patient for high-volume mHSPC.However,there was an additional 1.31 QALYs.With a gain of ICER at¥57565/QALY,rezvilutamide was cost-effective at a cost-effectiveness threshold of¥85698 per QALY in 2022(one-time GDP per capita).Base-case analysis was most sensitive to OS hazard ratio of rezvilutamide versus apalutamide.With a costeffectiveness threshold of one-time GDP per capita,the cost-effective probability of revirutamide was 60.1%.When PFS was defined as serum-free PSA progression,rezvilutamide also had an economic advantage over apalutamide.CONCLUSION Revirutamide is more cost-effective than apalutamide for Chinese patients with high-volume mHSPC.