OBJECTIVES : To evaluate the incremental life-years (LY) and quality-adjusted life years (QALY) of avelumab in combination with axitinib compared with sunitinib and pazopanib in the first-line treatment of advanced renal cell carcinoma (aRCC) in patients with intermediate or poor risk and of temsirolimus in patients with poor risk in Portugal.

METHODS : The analysis was based on a partitioned-survival model using data from the randomized phase 3 JAVELIN Renal 101 trial of avelumab plus axitinib vs sunitinib in aRCC. Parametric functions were chosen to extrapolate overall survival (OS) and progression-free survival (PFS) according to goodness-of-fit criteria. Time on treatment was assumed to be equal to PFS. For the comparisons vs pazopanib and temsirolimus, OS and PFS were modeled using hazard ratios obtained from a network meta-analysis. Utility weights, stratified by progression status, were estimated by applying the EQ-5D-5L Portuguese value set to the patient-reported outcomes from JAVELIN Renal 101. Disutilities due to adverse events were obtained from the literature. The analysis was conducted assuming a 40-year time horizon and a 4% discount rate, according to Portuguese methodological guidelines. Deterministic and probabilistic sensitivity analyses were conducted.

RESULTS : Avelumab in combination with axitinib increased average life expectancy by 0.57 undiscounted LY, enabling a discounted gain of 0.48 LY or 0.41 QALY compared with sunitinib. Compared with pazopanib, the average gains were 0.56 undiscounted LY, allowing a discounted increase of 0.47 LY or 0.39 QALY. Compared with temsirolimus, avelumab plus axitinib increased average life expectancy by 0.96 undiscounted LY, enabling a discounted gain of 0.81 LY or 0.70 QALY. Deterministic sensitivity analyses showed that the results were robust to most scenarios but sensitive to OS extrapolation options.

CONCLUSIONS : Avelumab results in increased LY and quality-adjusted life expectancy compared with sunitinib, pazopanib, and temsirolimus in the first-line treatment of aRCC in the Portuguese setting.