OBJECTIVES: An open-label, randomized phase III trial (REFLECT) has shown lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma (HCC). Although lenvatinb has been listed in America for several years, it has not been priced in China until November 2018. This study aimed to compare the cost-effectiveness of lenvatinib as first-line treatment for patients with unresectable HCC for both an American and Chinese perspective.

METHODS: A Markov model including three health states: progression-free survival (PFS), progressive disease (PD), and death simulates advanced HCC. Model inputs, such as clinical efficacy and adverse events, were derived from the open-label, phase III, multicentre, non-inferiority trial (REFLECT trial, NCT01761266) comparing lenvatinib with sorafenib as first-line treatment in patients with unresectable HCC. Utilities were extracted from public resources. Costs were calculated from both American and Chinese perspectives. Sensitivity analyses were conducted to explore the impact of uncertainty.

RESULTS: In the American scenario, treatment with lenvatinib for patients with advanced HCC was estimated to increase costs by $114,446 compared with sorafenib, with a gain of 0.05 quality adjusted life years (QALYs) for an incremental cost-effectiveness ratio (ICER) of $2,288,920 per QALY. From the Chinese perspective, the ICER was $732,840 per QALY. Lenvatinib is not cost effective in either scenario. The utility of the PFS and PD states had the greatest impact on the ICERs.

CONCLUSIONS: Lenvatinib is not a cost-effectiveness choice compared with sorafenib for patients with unresectable HCC from either an American perspective or Chinese perspective.