Zhao Qiuling, Xie Ruixiang, Zhong Wanfu, Liu Wenbin, Chen Ting, Qiu Xiuliang, Yang Lin
Department of Pharmacy, Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Fuzhou, China.
Department of Pharmacy, Fujian University of Traditional Chinese Medicine, Fuzhou, China.
Cost Eff Resour Alloc. 2023 Mar 1;21(1):19. doi: 10.1186/s12962-023-00429-9.
Durvalumab plus gemcitabine and cisplatin has a significant clinical benefit for advanced biliary tract cancer (BTC). However, the high price of durvalumab warrants an exploration of the economics.
To investigate the cost-effectiveness of adding durvalumab to gemcitabine and cisplatin compared with gemcitabine and cisplatin in first-line therapy of advanced BTC from the perspective of the Chinese healthcare system.
According to the TOPAZ-1 trial, a three-state Markov model was built by the TreeAge Pro 2022 software. The total costs and quality-adjusted life years (QALYs) were estimated, and the incremental cost-effectiveness ratio (ICER) was used as the evaluation index. The triple 2021 Chinese per capita gross domestic product (GDP) of $37,663.26/QALY was used as the willingness-to-pay (WTP) threshold. Outputs were analyzed for two scenarios with and without a durvalumab drug charity assistance policy. In the scenario analysis, the base-case model was run multiple times with different prices of durvalumab to determine the effect on the ICER. Moreover, the robustness of the model was tested through sensitivity analyses.
Compared with chemotherapy alone, durvalumab plus chemotherapy resulted in an additional 0.12 QALY and an incremental cost of $18,555.19, the ICER was $159,644.70/QALY under the situation of charity assistance, and the ICER was $696,571.11/QALY without charity assistance, both exceeding the WTP threshold in China. The scenario analysis demonstrated that when the price of durvalumab fell by more than 94.2% to less than $0.33/mg, durvalumab plus chemotherapy will be more economical compared with chemotherapy alone under the situation of no charity assistance. One-way sensitivity analyses suggested that the cost of durvalumab had the greatest influence on the ICERs, and the probabilistic sensitivity analyses demonstrated that durvalumab plus chemotherapy was impossible to be cost-effective at the WTP threshold whether the charity assistance was available or not.
Adding durvalumab to gemcitabine and cisplatin was not cost-effective for advanced BTC regardless of receiving and not receiving charitable assistance.
度伐利尤单抗联合吉西他滨和顺铂对晚期胆管癌（BTC）具有显著的临床益处。然而，度伐利尤单抗的高价格促使人们对其经济学进行探索。
从中国医疗保健系统的角度，研究在晚期BTC一线治疗中，与吉西他滨和顺铂相比，添加度伐利尤单抗的成本效益。
根据TOPAZ-1试验，使用TreeAge Pro 2022软件构建三状态马尔可夫模型。估计总成本和质量调整生命年（QALY），并将增量成本效益比（ICER）用作评估指标。将2021年中国人均国内生产总值的三倍37,663.26美元/QALY用作支付意愿（WTP）阈值。对有无度伐利尤单抗药物慈善援助政策的两种情况进行产出分析。在情景分析中，基础模型以不同的度伐利尤单抗价格运行多次，以确定对ICER的影响。此外，通过敏感性分析测试模型的稳健性。
与单纯化疗相比，度伐利尤单抗联合化疗可额外增加0.12个QALY，增量成本为18,555.19美元，在有慈善援助的情况下ICER为159,644.70美元/QALY，无慈善援助时ICER为696,571.11美元/QALY，均超过中国的WTP阈值。情景分析表明，在无慈善援助的情况下，当度伐利尤单抗价格下降超过94.2%至低于0.33美元/毫克时，度伐利尤单抗联合化疗比单纯化疗更经济。单向敏感性分析表明，度伐利尤单抗的成本对ICER影响最大，概率敏感性分析表明，无论有无慈善援助，度伐利尤单抗联合化疗在WTP阈值下都不太可能具有成本效益。
无论是否接受慈善援助，在吉西他滨和顺铂中添加度伐利尤单抗对晚期BTC都不具有成本效益。
