Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma: A cost-effectiveness analysis.

Abstract

Nivolumab plus ipilimumab has shown survival benefits as first-line treatment for unresectable hepatocellular carcinoma (HCC) but their high cost raises concerns about value. This study assessed the cost-effectiveness of nivolumab plus ipilimumab compared with lenvatinib or sorafenib from a United States (US) health care payer perspective. A partitioned survival model was developed using data from the CheckMate 9DW trial with a 10-year horizon. Costs and outcomes were discounted by 3% annually. Clinical inputs were derived from CheckMate 9DW trial, and cost inputs were obtained from public databases and published studies. Primary outcomes were quality-adjusted life years (QALYs), total costs, life years (LYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity and scenario analyses were conducted to test uncertainties. Nivolumab plus ipilimumab produced an incremental gain of 0.66 QALYs at an additional cost of $132,652, yielding an ICER of $200,409/QALY, above US willingness-to-pay thresholds ($100,000/QALY and $150,000/QALY). Probabilistic sensitivity analysis indicated a low probability of cost-effectiveness at current prices (4.6%-20%). Scenario analyses showed that extending maintenance nivolumab dosing from every 4 weeks to every 8 weeks reduced the ICER to $82,202/QALY, making the regimen cost-effective. Moderate price reductions also substantially increased the likelihood of cost-effectiveness. Nivolumab plus ipilimumab is unlikely to be cost-effective as first-line therapy for unresectable HCC from US health care payer perspective. However, extended dosing interval or price reductions may render the regimen economically viable, with important implications for clinical practice, payers, and policy.