Abstract
OBJECTIVE: This study aims to evaluate the cost-effectiveness of irinotecan hydrochloride liposome in combination with 5-fluorouracil and leucovorin (5-FU/LV) as a second-line treatment in locally advanced or metastatic pancreatic ductal adenocarcinoma, from the perspective of the healthcare system in China. METHODS: A partitioned survival model was developed based on data from PAN-HEROIC-1 clinical trial (NCT05074589) and relevant literature. The simulation horizon was set at 5 years, with a cycle length of 2 weeks. Costs and utility values were discounted at an annual rate of 5%. Quality-adjusted life years (QALYs) served as the primary outcome measure, and the incremental cost-effectiveness ratio was calculated to compare irinotecan hydrochloride liposome plus chemotherapy regimen (experimental group) with the 5-FU/LV regimen (control group). One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the results. RESULTS: The results revealed that the ICER for the experimental group compared to the control group was ¥1,271,796.38/QALY, exceeding the willingness-to-pay (WTP) threshold of three times China's per capita gross domestic product (GDP) in 2023. One-way sensitivity analysis indicated that parameters such as utility value during progression-free survival, body surface area, the cost of irinotecan hydrochloride liposome and the utility value during disease progression significantly influenced the model outcomes. Probabilistic sensitivity analysis demonstrated that the probability of the irinotecan hydrochloride liposome being cost-effective was 0. CONCLUSION: When using three times per capita GDP of China in 2023 as the WTP threshold, the irinotecan hydrochloride liposome plus chemotherapy regimen is not considered cost-effective compared to the standard 5-FU/LV regimen.