Department of Pharmacy, The Second Xiangya Hospital of Central South University, Changsha, 410011, Hunan, People's Republic of China.
PET-CT Center, The Second Xiangya Hospital of Central South University, Changsha, 410011, Hunan, People's Republic of China.
Clin Drug Investig. 2020 Feb;40(2):129-137. doi: 10.1007/s40261-019-00869-3.
BACKGROUND AND OBJECTIVE: The economic assessment of immuno-oncology agents in Chinese patients is limited despite a need for new therapies. Nivolumab is the first immune checkpoint inhibitor approved for the second-line treatment of non-small cell lung cancer (NSCLC) in China, and it significantly prolongs overall survival. However, considering the high cost of nivolumab, it is urgent to assess its value in China in terms of both efficacy and cost. The objective of this study was to investigate the cost-effectiveness of nivolumab vs docetaxel in the second-line setting for NSCLC patients from the Chinese healthcare system perspective. METHODS: A Markov model consisting of three health states, was designed to evaluate the lifetime cost and effectiveness of nivolumab vs docetaxel in the second-line treatment of NSCLC patients. Clinical data was derived from the CheckMate 078 phase III clinical trial, which included 504 patients predominantly from China. Parametric survival models to fit and extrapolate survival data were chosen based on clinical rationality, visual fit and statistical goodness-of-fit. Lifetime costs and health outcomes were calculated, and US$28,899 and $63,564 per quality-adjusted life-year (QALY) were selected as the willingness-to-pay (WTP) threshold values for general regions and affluent regions, respectively. One-way and probabilistic sensitivity analyses were undertaken to explore the robustness of the model. Additional subgroup analyses were performed. RESULTS: In base case analysis, Nivolumab yielded an additional 0.24 QALYs, at a cost of $93,307 per QALY. Sensitivity analyses suggested that the results to be most sensitive to the price of nivolumab per kg (mean $60.00; range $26.00-$60.00) and the mean patient weight (65 kg, range 52-78 kg). Utility values in progression-free survival state (mean 0.804; range 0.643-0.965) and overall survival hazard ratio (0.68; 97.7% CI 0.52-0.90) had moderate impact on the model results. Subgroup analyses indicated that nivolumab was most cost-effective for patients who were 65 years of age or older ($85,171/QALY), followed by female patients ($85,273/QALY) and patients with tumor PD-L1 expression at least 1% ($90,309/QALY). CONCLUSIONS: Nivolumab is unlikely to be cost-effective compared with docetaxel for patients with previously treated advanced NSCLC in China. Ensuring that nivolumab is included in the National Reimbursement Drug List (NRDL) may be a valid mean of meeting extensive treatment demands in China.
背景与目的:尽管需要新的治疗方法,但免疫肿瘤药物在中国患者中的经济评估仍很有限。纳武利尤单抗是中国批准用于二线治疗非小细胞肺癌(NSCLC)的首个免疫检查点抑制剂,可显著延长总生存期。然而,鉴于纳武利尤单抗的高成本,迫切需要从中国医疗保健系统的角度评估其在疗效和成本方面的价值。本研究旨在从中国医疗保健系统的角度,调查纳武利尤单抗与多西他赛二线治疗 NSCLC 患者的成本效益。
方法:设计了一个包含三个健康状态的 Markov 模型,以评估纳武利尤单抗与多西他赛二线治疗 NSCLC 患者的终生成本和疗效。临床数据源自 CheckMate 078 期 III 临床试验,该试验主要纳入了来自中国的 504 名患者。基于临床合理性、视觉拟合度和统计拟合优度,选择参数生存模型来拟合和外推生存数据。计算了终生成本和健康结果,并选择 28899 美元和 63564 美元作为一般地区和富裕地区的意愿支付(WTP)阈值。进行了单因素和概率敏感性分析以探索模型的稳健性。还进行了额外的亚组分析。
结果:在基准分析中,纳武利尤单抗在每个质量调整生命年(QALY)的成本为 93307 美元,可获得额外的 0.24 QALY。敏感性分析表明,结果对纳武利尤单抗每公斤的价格(平均 60.00 美元;范围 26.00-60.00 美元)和平均患者体重(65 公斤,范围 52-78 公斤)最为敏感。无进展生存期状态的效用值(平均 0.804;范围 0.643-0.965)和总生存风险比(0.68;97.7%CI 0.52-0.90)对模型结果有中度影响。亚组分析表明,纳武利尤单抗对 65 岁或以上的患者(每个 QALY 85171 美元)、女性患者(每个 QALY 85273 美元)和肿瘤 PD-L1 表达至少为 1%的患者(每个 QALY 90309 美元)最具成本效益。
结论:与多西他赛相比,纳武利尤单抗在中国二线治疗既往治疗的晚期 NSCLC 患者中不太可能具有成本效益。确保纳武利尤单抗被纳入国家医保药品目录(NRDL)可能是满足中国广泛治疗需求的有效途径。
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