Department of Medical Informatics and Statistics, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan; Department of Health Informatics, Niigata University of Health and Welfare, Niigata, Japan.
Department of Medical Informatics and Statistics, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan; Division of Digestive and General Surgery, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Clin Ther. 2017 Dec;39(12):2380-2388. doi: 10.1016/j.clinthera.2017.10.017. Epub 2017 Nov 27.
PURPOSE: The combination of paclitaxel + ramucirumab is a standard second-line treatment in patients with advanced gastric cancer. This therapy has been associated with increased median overall survival and progression-free survival compared with those with paclitaxel monotherapy. We evaluated the cost-effectiveness of paclitaxel + ramucirumab combination therapy in patients with advanced gastric cancer, from the perspective of health care payers in Japan. METHODS: We constructed a Markov model to compare, over a time horizon of 3 years, the costs and effectiveness of the combination of paclitaxel + ramucirumab and paclitaxel alone as second-line therapies for advanced gastric cancer in Japan. Health outcomes were measured in life-years (LYs) and quality-adjusted (QA) LYs gained. Costs were calculated using year-2016 Japanese yen (¥1 = US $17.79) according to the social insurance reimbursement schedule and drug tariff of the fee-for-service system in Japan. Model robustness was addressed through 1-way and probabilistic sensitivity analyses. The costs and QALYs were discounted at a rate of 2% per year. The willingness-to-pay threshold was set at the World Health Organization's criterion of ¥12 million, because no consensus exists regarding the threshold for acceptable cost per QALY ratios in Japan's health policy. FINDINGS: Paclitaxel + ramucirumab combination therapy was estimated to provide an additional 0.09 QALYs (0.10 LYs) at a cost of ¥3,870,077, resulting in an incremental cost-effectiveness ratio of ¥43,010,248/QALY. The incremental cost-effectiveness ratio for the combination therapy was >¥12 million/QALY in all of the 1-way and probabilistic sensitivity analyses. IMPLICATIONS: Adding ramucirumab to a regimen of paclitaxel in the second-line treatment of advanced gastric cancer is expected to provide a minimal incremental benefit at a high incremental cost per QALY. Based on our findings, adjustments in the price of ramucirumab, as well as improves in other clinical parameters such as survival time and adverse event in advanced gastric cancer therapy, are needed.
目的：紫杉醇+雷莫芦单抗联合治疗是晚期胃癌患者的标准二线治疗方案。与紫杉醇单药治疗相比，该疗法可显著提高中位总生存期和无进展生存期。我们从日本医保支付方的角度，评估了紫杉醇+雷莫芦单抗联合治疗晚期胃癌的成本效果。
方法：我们构建了一个马尔可夫模型，在 3 年的时间内，比较紫杉醇+雷莫芦单抗联合治疗和紫杉醇单药二线治疗晚期胃癌的成本和效果。健康结果以生命年（LY）和质量调整生命年（QA-LY）来衡量。成本根据日本社会保险报销标准和按服务收费制的药品定价，使用 2016 年日元（1 日元=0.01779 美元）进行计算。通过单因素敏感性分析和概率敏感性分析来验证模型的稳健性。成本和 QALY 均以每年 2%的贴现率进行贴现。意愿支付阈值设定为世界卫生组织（WHO）的 1.2 亿日元标准，因为在日本的卫生政策中，对于可接受的每质量调整生命年成本比率的阈值尚未达成共识。
结果：紫杉醇+雷莫芦单抗联合治疗估计可额外提供 0.09 QALY（0.10 LY），成本为 387 万日元，增量成本效果比为 4301 万日元/QALY。在所有单因素敏感性分析和概率敏感性分析中，联合治疗的增量成本效果比均超过 1.2 亿日元/QALY。
结论：在晚期胃癌二线治疗中，在紫杉醇治疗方案中加入雷莫芦单抗预计会以较高的增量成本获得每 QALY 最小的增量收益。根据我们的研究结果，需要调整雷莫芦单抗的价格，以及提高晚期胃癌治疗的其他临床参数，如生存时间和不良事件。
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