OBJECTIVES: Approximately 80% of newly diagnosed bladder cancer patients in the UK will be diagnosed with non-invasive bladder cancer (NIBC). The use of Hexvix (hexaminolevulinate) during transurethral resection of the bladder (TURB) results in a higher detection rate and more complete resection when compared to white light cystoscopy (WLC) alone. A decision tree model was developed to assess the budget impact associated with Hexvix. METHODS: The model structure, costs and treatment algorithms were based on the European Association of Urologist (EAU) guidelines, review of the literature and clinical practice in the UK. The model assumes a relative reduction in recurrence for Hexvix when compared to WLC based on data obtained with an unlicensed and less readily taken up fluorescent molecule. Model predictions include cost savings, reductions in procedures and disease-free days (DFD) over a two year time horizon. RESULTS: Of the 12,000 patients diagnosed with bladder cancer in the UK, 9641 were predicted by the model to have NIBC. In these patients, the model predicts an 18% reduction in the number of cystoscopies and 4.3% reduction in TURBs when Hexvix use was compared to WLC. In addition, an increase of 211 106 DFD was predicted over the 2 year time horizon (177,029 in 2410 high risk patients, 14,721 in 2410 medium risk patients and 19,355 in 4821 low risk patients). The model predicts an overall increase in cost of managing these patients of £2,769,712 (3.9%) over WLC, and an incremental cost of £21.90 per patient per disease-free year. CONCLUSION: Although the quality of life was not modelled the assumed reduction in the number of cystoscopies and TURBS could potentially have a significant impact on the quality of life. The increase in the cost of may be off-set by the improvement to the current regimen.