Abstract
BACKGROUND: Recurrent or metastatic head and neck cancer (R/M HNSCC) is highly prevalent in Southern China and Southeast Asia. Although immune checkpoint inhibitors such as finotonlimab combined with chemotherapy have shown promising survival benefits, their high costs pose challenges for healthcare systems in resource-constrained settings. This study aims to evaluate the cost-effectiveness of finotonlimab plus chemotherapy versus chemotherapy alone as the first-line treatment for R/M HNSCC from the perspective of the Chinese healthcare payer. METHODS: A 3-health-state Markov model was developed to simulate long-term clinical and economic outcomes for patients receiving either finotonlimab with cisplatin and 5-fluorouracil (finotonlimab + C5F) or placebo with C5F (Placebo + C5F). Survival data were reconstructed from published clinical trials and extrapolated using parametric models. Direct medical costs, health state utilities, and adverse event disutilities were sourced from the literature. The primary outcome was the incremental cost-effectiveness ratio (ICER), with a willingness-to-pay (WTP) threshold of $39,835.62 per quality-adjusted life year (QALY) gained. Sensitivity and scenario analyses were conducted to explore uncertainty. RESULTS: The finotonlimab + C5F group yielded 1.048 QALYs at a cost of $51,453.4, while the Placebo + C5F group yielded 0.788 QALYs at $22,020.2. The ICER was $113,051.4 per QALY gained, exceeding the WTP threshold. Scenario analysis revealed persistently high ICERs in finotonlimab + C5F group across different time horizons (2, 8, 10 years). One-way sensitivity analysis identified drug cost and PFS utility as the most influential parameters. Probabilistic analysis showed 0% probability of cost-effectiveness at the WTP threshold. CONCLUSION: Although finotonlimab combined with chemotherapy provides clinical benefits for patients with R/M HNSCC, it is not cost-effective at current pricing in China. Substantial price reductions, biomarker-guided patient selection, and inclusion in national reimbursement programs may improve its economic viability.