Abstract
Nivolumab plus ipilimumab (N+I) was the first immuno-oncology therapy combination to demonstrate long-term survival benefit in a clinical trial setting for patients with advanced renal cell carcinoma (aRCC). To evaluate the incremental cost effectiveness of N+I as first-line treatment for patients with aRCC from the Canadian public healthcare system perspective. A three-health state partitioned-survival model was developed to determine long-term clinical and economic outcomes of immunotherapy management for aRCC over a 15-year time horizon for the N+I combination therapy compared to sunitinib. Clinical data from an interim analysis of CheckMate 214 in the intermediate or poor-risk population based the International Metastatic Renal Cell Carcinoma Database Consortium, including survival estimates and time to treatment discontinuation, were used for treatments involving N+I and sunitinib. Real world data were used to validate the overall survival extrapolation curve choice. Utility data were based on Checkmate 214. Cost data were obtained from published literature, including adverse events, and clinical management of aRCC. In the reference case analysis, the incremental cost-utility ratio (ICUR) of N+I versus sunitinib was $128,997/QALY gained (95% CI= $54,608; $462,125) using a probabilistic approach. N+I had a 50% probability of being cost effective at a threshold of $118,000/QALY. At a $200,000/QALY threshold, N+I had an 83.3% probability of being cost effective compared to sunitinib. In the deterministic analysis, the ICUR was $113,732/QALY. In the scenario analysis, the introduction of a 5-year maximum treatment duration led to the lowest ICUR in the deterministic analysis ($89,124/QALY), while the use of the log-logistic curve to extrapolate the overall survival led to a highest ICUR ($136,797/QALY). N+I is a new cost-effective option in the aRCC first-line setting for patients at intermediate and poor-risk, especially in the scenario with a 5-year maximum treatment duration.
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