瑞波西利联合来曲唑一线治疗HR+/HER2−晚期或转移性乳腺癌的成本-效用分析

    Cost-utility Analysis of Ribociclib Combined with Letrozole as First-line Treatment for HR+/HER2− Advanced or Metastatic Breast Cancer

    • 摘要:
      目的 从中国卫生体系角度,评估瑞波西利联合来曲唑作为HR+/HER2−晚期或转移性乳腺癌一线治疗方案的成本-效用分析。
      方法 采用MONALEESA-2临床试验的疗效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 years,QALYs),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,WTP)为2023年中国3倍人均GDP(268 074元·QALY−1)。通过单因素敏感性分析和概率敏感性分析来评估模型的稳健性,并进行了情景分析。
      结果 基础分析结果显示,瑞波西利联合来曲唑同来曲唑单药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为0.81 QALYs和186 527.76元,两方案相比的ICER值为230 994.70元·QALY−1。单因素敏感性分析、概率敏感性分析以及情景分析证实了模型结果具有稳健性。情景分析结果显示,随着模拟时限的延长,瑞波西利联合来曲唑的ICER值逐渐降低,下降幅度趋于减小,>15年的长期治疗方案具备较高的成本效益。
      结论 从中国卫生体系角度来看,瑞波西利联合来曲唑作为绝经后HR+/HER2−晚期或转移性乳腺癌患者一线治疗具有较高的成本效益,且在较长的模拟时限下显示出更强的经济性。

       

      Abstract:
      OBJECTIVE  To evaluate the cost-effectiveness of ribociclib in combination with letrozole as a first-line treatment for HR+/HER2− advanced or metastatic breast cancer from the perspective of the Chinese healthcare system.
      METHODS The partitioned survival model was constructed using the survival data of MONALEESA-2 clinical trial, along with relevant cost and utility data. The model cycle was set at 4 weeks, with a simulation time horizon of 20 years, and a discount rate of 5%. The output measures of the model were cost and quality adjusted life years(QALYs), and the evaluation metric was the incremental cost-effectiveness ratio(ICER). The willingness-to-pay(WTP) threshold was set at three times China’s per capita GDP in 2023( ¥268074·QALY−1). The robustness of the model was assessed through one-way sensitivity analysis and probabilistic sensitivity analysis, and scenario analyses were also conducted.
      RESULTS The base case analysis results indicated that ribociclib combined with letrozole provided greater health benefits compared to letrozole monotherapy, but it also incurred higher total costs. The incremental utility and incremental cost were 0.81 QALYs and ¥186527.76, respectively, resulting in an ICER of ¥230994.70·QALY−1 for the comparison between the two regimens. One-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis confirmed the robustness of the model results. The scenario analysis results showed that as the simulation time horizon extended, the ICER value of ribociclib combined with letrozole gradually decreased, with the rate of decline tending to diminish. Long-term treatment regimens exceeding 15 years demonstrated higher cost-effectiveness.
      CONCLUSION From the perspective of the Chinese healthcare system, ribociclib in combination with letrozole as a first-line treatment for postmenopausal patients with HR+/HER2− advanced or metastatic breast cancer has high cost-effectiveness. Additionally, the treatment shows stronger economic viability over longer time horizons.

       

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