Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Department of Pharmacy, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Front Public Health. 2023 Feb 10;11:1046424. doi: 10.3389/fpubh.2023.1046424. eCollection 2023.
The TOPAZ-1 trial reported a significant survival benefit of durvalumab in combination with chemotherapy for the first-line treatment of biliary tract cancer (BTC). However, no studies have evaluated the economics of this treatment option. The aim of this study was to assess the cost effectiveness of durvalumab plus chemotherapy compared to placebo plus chemotherapy from the perspective of US and Chinese payers.
Based on clinical data from the TOPAZ-1 trial, a Markov model was developed to simulate 10-year life expectancy and total healthcare costs for patients with BTC. The treatment group received durvalumab in combination with chemotherapy and the control group received placebo plus chemotherapy. The primary outcomes analyzed included quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Uncertainty in the analysis results was assessed by sensitivity analysis.
For US payers, the placebo plus chemotherapy group had a total cost of $56,157.05 and a utility of 1.10 QALYs, while the durvalumab plus chemotherapy group had a total cost of $217,069.25, a utility of 1.52 QALYs, resulting in an ICER of $381,864.39/QALY. For Chinese payers, the ICER of durvalumab plus chemotherapy group was $367,608.51/QALY. Sensitivity analysis showed that the analysis was most sensitive to the price of durvalumab. For US and Chinese payers, under the respective willing to pay thresholds, the likelihood of the durvalumab plus chemotherapy arm being cost-effective was 0%.
Both in China and in the US, durvalumab in combination with chemotherapy is not a cost-effective option for the first-line treatment of BTC compared with chemotherapy.
TOPAZ-1 试验报告称，在胆管癌（BTC）一线治疗中，度伐利尤单抗联合化疗具有显著的生存获益。然而，目前尚无研究评估该治疗方案的经济学价值。本研究旨在从美国和中国支付者的角度评估度伐利尤单抗联合化疗与安慰剂联合化疗相比的成本效果。
基于 TOPAZ-1 试验的临床数据，建立了一个马尔可夫模型，以模拟 BTC 患者 10 年预期寿命和总医疗成本。治疗组接受度伐利尤单抗联合化疗，对照组接受安慰剂联合化疗。主要结局分析包括质量调整生命年（QALYs）和增量成本效果比（ICERs）。通过敏感性分析评估分析结果的不确定性。
对于美国支付者，安慰剂联合化疗组的总费用为 56157.05 美元，效用为 1.10 QALYs，而度伐利尤单抗联合化疗组的总费用为 217069.25 美元，效用为 1.52 QALYs，ICER 为 381864.39 美元/QALY。对于中国支付者，度伐利尤单抗联合化疗组的 ICER 为 367608.51 美元/QALY。敏感性分析表明，该分析对度伐利尤单抗的价格最为敏感。对于美国和中国的支付者，在各自的意愿支付阈值下，度伐利尤单抗联合化疗组具有成本效果的可能性均为 0%。
在中国和美国，与化疗相比，度伐利尤单抗联合化疗作为 BTC 一线治疗方案，不具有成本效果。
