Budget Impact Analysis of Avelumab + Best Supportive Care (BSC) as First-Line Maintenance Treatment in Patients With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) in Ireland

OBJECTIVES: To estimate the budget impact of avelumab + BSC in the overall la/mUC treatment paradigm in Ireland and to demonstrate potential cost offsets.

METHODS: A budget impact model (BIM) was developed in line with the National Centre for Pharmacoeconomics (NCPE) BIM template. This Excel-based model was used to derive the gross budget impact (GBI) and net budget impact (NBI) results (scenarios with and without avelumab as first-line maintenance treatment). Two approaches to estimate the eligible population were explored, using Irish epidemiology estimates where available. The BIM adopted the perspective of the Health Service Executive (HSE); only direct medical costs were considered over a 5-year time horizon. NCPE guidelines for medicine acquisition costs were followed. Avelumab medicine acquisition costs were estimated using time-on-treatment data derived from the accompanying avelumab + BSC cost-effectiveness analysis. For the NBI results, the current and future treatment paradigms for patients with la/mUC were identified and validated by clinical experts. Dosing information for different lines of treatment regimens was informed by national treatment protocols and product licenses.

RESULTS: Approximately 95 patients may be eligible for maintenance treatment with avelumab each year (5-year cumulative N=475). Estimated 5-year GBI is €32.57 million. From an NBI perspective, reflecting scenarios with and without the introduction of avelumab maintenance into the treatment paradigm is estimated to cost the HSE €17.93 million over 5 years. An average of €3.59 million annually would facilitate access to avelumab as part of overall treatment for la/mUC, reflecting the impact of displacing second-line treatments.

CONCLUSIONS: Avelumab is the first licensed maintenance treatment for la/mUC. Avelumab has the potential to address unmet clinical needs and improve survival outcomes while maintaining health-related quality of life for patients with la/mUC, with a modest budget impact. Additional savings may also be realized through final HSE negotiations.