OBJECTIVES: To evaluate the cost-effectiveness of avelumab plus BSC vs BSC alone for first-line (1L) maintenance treatment of adult patients with la/mUC who are progression-free following platinum-based chemotherapy in France.

METHODS: A partitioned survival model was developed, including progression-free, post progression, and death as health states, based on extrapolated outcomes from the phase 3 JAVELIN Bladder 100 trial, considering a 10-year time horizon and a weekly cycle length. Treatment discontinuations, grade 1/2 adverse events (AEs) with the highest impact on quality of life, and all grade 3/4 AEs were accounted for. Utilities by health state were based on EQ-5D-5L values from the trial using French preferences. Disutilities associated with AEs were sourced from literature. Costs were estimated from a collective perspective and included treatment acquisition, administration, follow-up, AE-related hospitalization, transport, postprogression, and end-of-life costs. Deterministic, probabilistic sensitivity and scenario analyses were conducted to assess the impact of uncertainty. Costs and clinical outcomes were discounted at 2.5% per annum.

RESULTS: Avelumab plus BSC was associated with 2.49 quality-adjusted life-years (QALYs) vs 1.82 QALYs for BSC (+0.67 QALYs), which were driven by 0.48 and 0.29 additional years, respectively, in the progression-free and postprogression health states. While avelumab was associated with increased acquisition costs vs BSC, some offsets were observed for postprogression and end-of-life costs (−€20,424 and −€351, respectively). Sensitivity analyses were consistent with the base case and showed that efficacy parameters (overall survival, time-to-treatment discontinuation), postprogression time on immunotherapy, and postprogression costs had the biggest impact on incremental cost-effectiveness ratio.

CONCLUSIONS: The Haute Autorité de Santé found the evaluation to be acceptable and robust with limited uncertainty. The analysis demonstrated that avelumab is likely to be cost-effective vs BSC in patients eligible for 1L maintenance treatment of la/mUC in France.