Anlotinib plus penpulimab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma: a cost-effectiveness analysis from the perspective of the Chinese healthcare system

Background In the phase III clinical trial named APOLLO (NCT04344158), anlotinib plus penpulimab significantly improved PFS and OS compared with sorafenib in the first-line treatment of unresectable hepatocellular carcinoma (uHCC). Although targeted agents combined with immunotherapy offer a new treatment option for uHCC and provide significant benefits, their cost-effectiveness in China remains unclear. This study aimed to evaluate the cost-effectiveness of anlotinib plus penpulimab for uHCC from the perspective of the Chinese healthcare system, in accordance with the latest China Guidelines for Pharmacoeconomic Evaluations 2025 . Methods A partitioned survival model was used to assess the cost-effectiveness of anlotinib plus penpulimab over sorafenib monotherapy as a first-line treatment therapy for uHCC from the perspective of the Chinese healthcare system. The time horizon was the patient’s lifetime, with a cycle of 21 days. Clinical information was derived from the APOLLO trial, cost and health state utility data were derived from local databases and published literature. Quality-adjusted life years (QALY) were used as the model’s main outcome indicator, sensitivity analyses were conducted. Results In the base-case analysis, anlotinib plus penpulimab provided an additional 0.58 QALYs at an incremental total cost of United States dollar ($)24,637.23, with an incremental cost-effectiveness ratio (ICER) of $ 42,319.31/QALY, which was higher than the willingness-to-pay (WTP) threshold of $ 27,766.48/QALY. One-way sensitivity analysis showed that the results of the model were most sensitive to the utility value of the PD state and the price of penpulimab. Sensitivity analyzes indicated that our results were robust to the variation ranges of key inputs. Scenario analysis confirmed that when the prices of penpulimab was reduced by 50%, the cost-effectiveness of the anlotinib plus penpulimab is significantly improved. Conclusion In this economic evaluation comparing two first-line treatments for patients with uHCC, anlotinib plus penpulimab was not more cost-effective than sorafenib from the perspective of the Chinese healthcare system. However, this outcome could be altered if penpulimab undergoes a substantial price reduction.