OBJECTIVE: To estimate the budget impact of introducing avelumab as a 
second-line (2L) treatment option for patients with locally advanced or 
metastatic urothelial cancer (mUC) from the perspective of a US third-party 
payer (commercial and Medicare).
METHODS: A budget impact model (BIM) with a three-year time horizon was 
developed for avelumab. Efficacy and safety data were sourced from published 
literature and US package inserts. The analysis was conducted in collaboration 
with a specialist oncologist who validated clinical assumptions. Costs were 
based on the number of eligible patients, time-to-treatment failure, overall 
survival, adverse events (AEs), and projected market shares of various 
treatments.
RESULTS: In a hypothetical commercial health plan of 30,000,000 members, 884 
patients were estimated to be eligible for 2L treatment over a three-year time 
period. Without avelumab, the total cost for treating patients with mUC was 
estimated to be US$70,268,035. The introduction of avelumab increased total 
costs by $73,438 (0.10% increase). In a hypothetical Medicare health plan of 
30,000,000 beneficiaries, a total of 4,705 patients were estimated to be 
eligible for 2L treatment. Without avelumab, the total cost for treating 
patients with mUC was estimated to be $292,923,098 from a Medicare perspective; 
however, with avelumab, there was an increase of $719,324 (0.25% increase) in 
total costs. Results of the sensitivity analyses demonstrated a cost-neutral 
impact across all tested scenarios from both perspectives.
CONCLUSION: The BIM estimated that avelumab would have a cost-neutral impact 
within a US commercial and a Medicare health plan. Overall, avelumab can be an 
affordable and valuable treatment option for patients with locally advanced or 
mUC in the 2L setting. These findings demonstrate a consistently favorable 
budget impact in both populations. Further studies should be conducted to more 
comprehensively assess the clinical and economic implications of adding avelumab 
to the treatment armamentarium of 2L mUC.