AbstractBackground.Treatment options for patients with platinum‐refractory, recurrent, metastatic head and neck squamous cell carcinoma (r/m HNSCC) are limited and prognosis is poor. The recent CheckMate 141 clinical trial demonstrated that nivolumab, an anti‐programmed cell death protein 1 monoclonal antibody, was efficacious in extending the median overall survival (OS) in this patient population compared with standard therapies. We conducted a cost‐effectiveness analysis to determine whether nivolumab is a cost‐effective treatment in this patient population and examined various subgroups to determine for which, if any, the treatment is more cost‐effective.Materials and Methods.We implemented a state transition model for HNSCC with a patient cohort who had tumor progression 6 months after the last dose of platinum‐containing chemotherapy and compared the cost‐effectiveness of nivolumab with docetaxel. Treatment effect estimates and adverse event rates were obtained from CheckMate 141. Costs, utilities, and other model inputs were gathered from published sources. We used a Canadian perspective, a 5‐year time horizon, and a 1.5% discount rate for the analysis.Results.Nivolumab extended mean OS by 4 months compared with docetaxel and resulted in fewer treatment‐related adverse events, producing an incremental effectiveness of 0.13 quality‐adjusted life years (QALY). The incremental cost of treatment with nivolumab was $18,823. At a willingness‐to‐pay threshold of $100,000/QALY, nivolumab was not a cost‐effective treatment option for r/m HNSCC, with an incremental cost‐effectiveness ratio of $144,744/QALY. Nivolumab would be cost‐effective if its price was reduced by 20%. Our subgroup analysis seemed to indicate that nivolumab might be cost‐effective for tumors with expression of programmed death‐ligand 1 >5%.Conclusion.We conclude that although nivolumab offers clinical benefit for the treatment of r/m HNSCC over current regimens, it is not cost‐effective based on its list price. We have also established a value‐based price estimate for nivolumab to be cost‐effective in this patient population. Further study is required to draw a definitive conclusion on biomarkers for cost‐effectiveness.Implications for Practice.In health care settings in which cost considerations are a constraint on choice of therapy, patient selection should be carefully considered to maintain efficiency in the system. Until a biomarker for response to therapy is identified for nivolumab, this medication is unlikely to be cost‐effective for most patients with recurrent, metastatic head and neck squamous cell carcinoma.
Cost‐Effectiveness of Nivolumab in Recurrent Metastatic Head and Neck Squamous Cell Carcinoma
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