OBJECTIVES: Bladder cancer is the fifth leading type of cancer diagnosed in Belgium. Early detection is key in improving survival. Hexvix, by inducing tumor fluorescence during cystoscopies, improves lesion detection, delineation and therefore also lesion resection. The cost-effectiveness of adding Hexvix to standard white light cystoscopy in the diagnosis and management of non-muscle invasive bladder cancer was assessed from the Belgian health care payers' perspective. METHODS: A Markov model with a 10 year time horizon, describing management patterns and resulting outcomes in patients with suspected bladder cancer, was developed in Excel. Treatment patterns and clinical evolution of high (HR), medium (MR) and low (LR) risk patients were derived from European treatment guidelines and further validated by a panel of 3 Belgian urologists. By using Hexvix in diagnostic cystoscopies bladder cancer could potentially be detected at an earlier stage (4% HR diagnosed in MR and 4% MR in LR) and resection could be more complete resulting in lower recurrence rates (HR:-50%; MR:-40% and LR:-30%; based on data obtained with an unlicensed, less readily taken up fluorescent molecule). Official tariffs were applied to medical resources identified. An annual discount rate of 3% for future cost and 1.5% for effects was applied. Results were expressed as cost per life year gained (LYG). RESULTS: Using this model, compared to standard white light cystoscopy adding Hexvix, in diagnostic and therapeutic cystoscopies, increased survival per patient could be 0.09 years at an incremental cost of €496, resulting in an incremental cost-effectiveness ratio of €5470/LYG. LYG and incremental costs were respectively most sensitive to time-horizon and the effect of Hexvix on recurrence rate (€3,251/LYG to €25,549/LYG). CONCLUSION: Compared to standard white light cystoscopy alone, in this hypothetical model adding Hexvix to this procedure appears to be cost-effective in Belgium from the health care payer's perspective.