OBJECTIVES: We evaluated the incremental cost-effectiveness of nivolumab in combination with ipilimumab (NIVO+IPI) versus currently available first-line treatments in patients with intermediate/poor prognosis in previously untreated, advanced or metastatic renal cell carcinoma (aRCC).

METHODS: A partitioned survival model was developed with five health states, allowing for on and off treatment for progression-free and post-progression states. First-line comparators included commonly used targeted therapies: sunitinib, pazopanib, and cabozantinib. Time-to-treatment discontinuation, progression-free survival (PFS), and overall survival (OS) for NIVO+IPI and sunitinib were modeled using CheckMate 214 data. The PFS and OS for comparators were obtained from a Bayesian network meta-analysis, applying a relative treatment effect versus sunitinib. The lifetime horizon was a maximum of 40 years, based on patient median age at diagnosis (62 years). Based on clinical expert inputs and the CheckMate 214 trial protocol, a 2-year maximum treatment duration was applied for NIVO+IPI in the base case. Three and five-year durations were tested as scenario analysis. US-specific costs (acquisition costs, adverse events, subsequent therapies) and resource use inputs were sourced from literature review and validated by clinical experts. Utility values were sourced from CheckMate 214. Uncertainty was tested via deterministic and probabilistic sensitivity analysis.

RESULTS: In the base case, NIVO+IPI was associated with the highest number of quality-adjusted life-years (QALYs) and life-years gained (4.75 and 5.62, respectively), and a total cost of $353,157. The efficiency frontier is represented by sunitinib and NIVO+IPI, with an absolute cost increment of $5,013 and an absolute QALY increment of 1.25. The associated incremental cost-effectiveness ratio (ICER) versus sunitinib was $3,995/QALY. In the three-year and five-year scenario analyses, the ICER was $28,617/QALY and $60,760/QALY, respectively. Key model outcome drivers were efficacy and utility estimates.

CONCLUSIONS: This model demonstrated that NIVO+IPI is more cost-effective than currently available first-line targeted monotherapies including sunitinib, pazopanib, and cabozantinib.