Department of Pharmaceutical Regulatory Science and Pharmacoeconomics, School of Pharmacy, Nanjing Medical University, Nanjing, China.
Department of Drug Clinical Trial Institution, Fujian Cancer Hospital, Fuzhou, Fujian, China.
Front Immunol. 2023 May 29;14:1169752. doi: 10.3389/fimmu.2023.1169752. eCollection 2023.
Toripalimab is the first domestic anti-tumor programmed death 1 antibody marketed in China. The CHOICE-01 trial (identifier: NCT03856411) demonstrated that toripalimab plus chemotherapy can significantly improve the clinical outcomes of advanced non-small cell lung cancer (NSCLC) patients. However, whether it is cost-effective remains unknown. Given the high cost of combination therapy, a cost-effectiveness analysis of toripalimab plus chemotherapy (TC) versus chemotherapy alone (PC) for the first-line treatment of patients with advanced NSCLC is required.
A partitioned survival model was adopted to predict the course of disease in advanced NSCLC patients on TC or PC from the perspective of the Chinese healthcare system over a 10-year horizon. The survival data were obtained from the CHOICE-01 clinical trial. Cost and utility values were obtained from local hospitals and kinds of literature. Based on these parameters, the incremental cost-effectiveness ratio (ICER) of TC vs. PC was measured, and one-way sensitivity analyses, probabilistic sensitivity analyses (PSA), and scenario analyses were performed to assess the robustness of the model.
In the base case, TC was associated with an incremental cost of $18510 and an incremental quality-adjusted life year (QALY) of 0.57 compared with PC, resulting in an ICER of $32237/QALY which was lower than the willingness to pay (WTP) threshold ($37654/QALY), TC was cost-effective. The health utility value of progression-free survival, the price of toripalimab, and the cost of best supportive care were factors that significantly influenced the ICER, but no change in any of them could change the model result. TC showed a 90% probability of being a cost-effective option at a WTP threshold of $37,654/QALY. In the 20 and 30-year time horizons, the results remained unchanged and TC remained cost-effective when the second-line treatment was switched to docetaxel.
At a WTP threshold of $37,654 per QALY, TC was cost-effective compared to PC for patients with advanced NSCLC in China.
特瑞普利单抗是中国首个上市的国产抗肿瘤 PD-1 抗体。CHOICE-01 研究（标识符：NCT03856411）表明，特瑞普利单抗联合化疗可显著改善晚期非小细胞肺癌（NSCLC）患者的临床结局。然而，其是否具有成本效益尚不清楚。鉴于联合治疗费用较高，有必要对特瑞普利单抗联合化疗（TC）与单纯化疗（PC）作为晚期 NSCLC 一线治疗的成本效益进行分析。
采用分割生存模型，从中国医疗保健体系的角度预测 TC 或 PC 治疗晚期 NSCLC 患者 10 年内的疾病进程。生存数据来自 CHOICE-01 临床试验。成本和效用值来自当地医院和各种文献。基于这些参数，测量 TC 与 PC 的增量成本效益比（ICER），并进行单因素敏感性分析、概率敏感性分析（PSA）和情景分析，以评估模型的稳健性。
在基准情况下，TC 与 PC 相比，增量成本为 18510 美元，增量质量调整生命年（QALY）为 0.57，导致 ICER 为 32237 美元/QALY，低于意愿支付（WTP）阈值（37654 美元/QALY），TC 具有成本效益。无进展生存期的健康效用值、特瑞普利单抗的价格和最佳支持治疗的成本是影响 ICER 的重要因素，但它们中的任何一个变化都不会改变模型结果。在 WTP 阈值为 37654 美元/QALY 时，TC 有 90%的概率成为一种成本效益选择。在 20 年和 30 年的时间范围内，当二线治疗切换为多西他赛时，结果保持不变，TC 仍然具有成本效益。
在中国，与 PC 相比，在 WTP 阈值为 37654 美元/QALY 时，TC 对晚期 NSCLC 患者具有成本效益。
