Estimated cost-effectiveness of adjuvant nivolumab for resected stage IIB–IIC melanoma in the United States

BACKGROUND: The CheckMate 76K trial analysis showed that the use of nivolumab as adjuvant therapy in the treatment of patients with resected stage IIB-IIC melanoma reduced recurrence-free survival (RFS). This study aimed to estimate the cost-effectiveness of nivolumab as adjuvant therapy in these patients from the United States (U.S.) payer perspective. RESEARCH DESIGN AND METHODS: A cohort-based Markov model with monthly cycles was developed to simulate RFS over a Five-year base-case horizon. Health states included recurrence-free without adverse events, recurrence-free with adverse events, and disease recurrence (absorbing). Transition probabilities were derived from parametric survival models fitted to reconstructed individual patient-level RFS data. Sensitivity and scenario analyses were applied. RESULTS: Over five years, nivolumab increased costs by USD 182,783 and yielded 0.444 additional quality-adjusted life-years (QALYs), resulting in an incremental cost-effectiveness ratio (ICER) of USD 411,958 per QALY. Nivolumab was not cost-effective at conventional U.S. willingness-to-pay thresholds in the base case. Sensitivity analyses confirmed robustness, while scenarios assuming greater durability of benefit improved cost-effectiveness but generally remained above thresholds. CONCLUSIONS: Within a conservative recurrence-focused framework, adjuvant nivolumab improves health outcomes but is unlikely to be cost-effective at current prices over a short-term horizon. Reassessment will be essential as longer-term evidence emerges.