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

Abstract

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.