Nivolumab dose stewardship in routine Oncology practice: a real-world health-economic simulation

BACKGROUND: Immune checkpoint inhibitors improve outcomes across solid tumors but increase oncology drug expenditure. This study estimated the impact of a predefined nivolumab dose stewardship algorithm on drug utilization, nivolumab drug cost, and vial waste. RESEARCH DESIGN AND METHODS: We performed a single-center retrospective drug-cost and resource-utilization simulation using real-world data from adults who received nivolumab between 2024 and 2026. Observed dosing was compared with a modeled policy incorporating weight-informed dosing, vial-based dose rounding, and preservation of protocol-mandated fixed-dose regimens. Clinical outcomes and adverse events were not assessed; clinical equivalence was assumed for modeling purposes but not demonstrated. RESULTS: Among 102 patients, median age was 64 years, body weight was 70 kg, and exposure was 9.5 cycles. The modeled policy reduced nivolumab consumption from 432,360 mg to 342,360 mg, saving 90,000 mg (20.8%). Estimated nivolumab drug cost decreased from 221,040,980 TL to 175,029,119 TL, saving 46,011,861 TL. Vial waste decreased from 43,360 mg to 2,000 mg, a 95.4% reduction. CONCLUSIONS: This retrospective simulation suggests that a predefined nivolumab dose stewardship algorithm may reduce drug use, drug cost, and vial waste. Prospective studies are required before clinical implementation.