Division of Pharmacy, Graduate School of Medical Sciences, Kanazawa University, Kakuma-machi, Kanazawa, 920-1192, Japan.
Department of Pharmacy, First Towakai Hospital, Takatsuki, Japan.
BMC Health Serv Res. 2019 Jul 1;19(1):438. doi: 10.1186/s12913-019-4281-0.
An antiemetic triplet regimen of 5-hydrotryptamine-3 receptor antagonist, dexamethasone, and aprepitant is the standard prophylaxis with highly emetogenic chemotherapy (HEC). A randomized phase III trial comparing palonosetron (PALO) versus granisetron (GRA) in the triplet antiemetic regimen (The TRIPLE study) showed the superiority of PALO over GRA for delayed-phase vomiting in patients receiving cisplatin-based HEC. However, economic efficiency evaluations including quality of life have not been done. The present study was a cost-utility analysis of PALO within the Japanese medical insurance system.
The data source was the results of the TRIPLE study. A decision tree was constructed to assess the incremental cost-effectiveness ratio (ICER) using quality-adjusted life years (QALYs) and the medical service fees and the drug price for 2018 from the perspective of the payer. A one-way sensitivity analysis and a probabilistic sensitivity analysis (PSA) were performed to assess the robustness of the model. A threshold analysis was performed to determine the cost-effective price of PALO.
In the base case, the estimated incremental effect of PALO addition was 0.000645 QALYs, the estimated incremental cost was 10,455 JPY (93.21 USD), and the ICER was 16,204,591 JPY QALY (144,465 USD/QALY). In the PSA, the probability of superior cost-effectiveness was 3.64%. In the threshold analysis, the acceptable price of PALO was estimated to be 7,743 JPY (69.03 USD).
If willingness-to-pay is taken as 5,000,000 JPY/QALY (44,575 USD/QALY), the antiemetic regimen using PALO for cisplatin-containing HEC was not cost-effective at this time. The cost of drugs, with the arrival of inexpensive generic drugs, will make a major contribution to its cost-effectiveness.
含 5-羟色胺 3 受体拮抗剂、地塞米松和阿瑞匹坦的止吐三联方案是高度致吐性化疗（HEC）的标准预防方案。一项比较帕洛诺司琼（PALO）与格拉司琼（GRA）在三联止吐方案中的疗效的随机 III 期试验（TRIPLE 研究）表明，PALO 对接受顺铂为基础的 HEC 患者的延迟期呕吐的疗效优于 GRA。然而，尚未进行包括生活质量在内的经济效率评估。本研究是在日本医疗保险体系内对 PALO 进行成本-效用分析。
数据来源于 TRIPLE 研究的结果。采用决策树从支付者的角度评估质量调整生命年（QALY）和医疗服务费用以及 2018 年药物价格的增量成本效果比（ICER）。进行了单因素敏感性分析和概率敏感性分析（PSA），以评估模型的稳健性。进行了阈值分析，以确定 PALO 的成本效益价格。
在基准情况下，PALO 加用的估计增量效果为 0.000645 QALY，估计增量成本为 10,455 日元（93.21 美元），ICER 为 16,204,591 日元 QALY（144,465 美元/QALY）。在 PSA 中，成本效益更高的概率为 3.64%。在阈值分析中，PALO 的可接受价格估计为 7,743 日元（69.03 美元）。
如果以 500 万日元/QALY（44,575 美元/QALY）为意愿支付价格，此时含顺铂的 HEC 用 PALO 的止吐方案不具有成本效益。随着廉价仿制药的出现，药物成本将对其成本效益产生重大影响。
