Nivolumab plus ipilimumab versus lenvatinib or sorafenib for US and Chinese patients with unresectable hepatocellular carcinoma: a cost-effectiveness analysis

Background: The CheckMate 9DW trial showed that nivolumab plus ipilimumab (NIVO + IPI) improves overall survival over lenvatinib or sorafenib (LEN/SOR) in patients with unresectable hepatocellular carcinoma (uHCC). We evaluated the cost-effectiveness of NIVO + IPI versus LEN/SOR from payer perspectives in the United States (US) and China, explicitly aiming to inform reimbursement and price-negotiation decisions in each setting. Methods: Based on the overall and subgroup data from the CheckMate 9DW trial, we developed a partitioned survival model to compare the clinical outcomes of NIVO + IPI versus LEN/SOR. Costs included drugs, administration, monitoring, adverse event management, and follow-up care in both the US and China. A lifetime horizon (1-month cycles) and 2024 US dollars were applied. The primary outcome was the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained. Willingness-to-pay (WTP) thresholds were 150, 000/QALY (US) and 39, 933. 67/QALY (China). Model uncertainty was assessed through one-way and probabilistic sensitivity analyses. Results: In the US, the NIVO + IPI regimen generated an incremental gain of 0. 68 QALYs at an additional cost of 86, 403. 43, resulting in an ICER of 127, 063. 87 per QALY. In the China subgroup, NIVO + IPI yielded an incremental gain of 0. 94 QALYs with an incremental cost of 35, 358. 47, corresponding to an ICER of 37, 615. 40 per QALY. Sensitivity analyses indicated that the ICER was mostly influenced by variations in the discount rate and drug prices. Probabilistic sensitivity analysis demonstrated that the probability of NIVO + IPI being cost-effective exceeded 50% at the respective WTP thresholds in both the United States and China. Conclusion: This study suggests that NIVO + IPI is cost-effective in both the United States and China at current price levels.