OBJECTIVES The objective of the analysis was to assess the pricing and reimbursement possibilities, as well as the budget impact, of a new medicine for bladder cancer immunotherapy. METHODS We investigated the number of medicines for bladder cancer immunotherapy that were registered and listed in the period between March 2011 and March 2014, in Serbia. We also made pharmacoeconomics analysis that would be a part of the Health Insurance Fund submission file. RESULTS According to the European Association of Urology (EAU) Guidelines for non-muscle invasive bladder cancer (NMIBC) there are several bladder preservation strategies available: intravesical immunotherapy, intravesical chemotherapy, device-assisted therapy and combination therapy. In Serbia, there are three medicines listed for chemotherapy (doxorubicin, epirubicin and mitomycin) and one for intravesical immunotherapy (BCG). BCG has become the standard of care for high-grade NMIBC and carcinoma in-situ (CIS) and is superior to intravesical chemotherapy in reducing recurrences, in preventing or delaying progression of the disease. Radical cystectomy should be considered after BCG treatment failure, when BCG is contraindicated or not available. BCG is reimbursed in Serbia (wholesale price: 79,18€) but due to continuous shortages of registered BCG from May 2012, non-registered BCG was also listed (price: not defined). Still there was no import, due to worldwide shortages. The absence of the treatment encouraged the Serbian Institute of Virology, Vaccines and Sera "Torlak" to develop BCG for immunotherapy. As the price proposal for new medicine would be 55,43€, expenses per patient per year would be 498,87€ and total costs for 520 patients would be 259.412,40€, it is projected that total savings would be 111.150,00€ per year. Market share of domestic BCG would be 0,29% of total B list (hospital medicines) budget. CONCLUSIONS The future aim is to develop, register and list domestic BCG that would provide lower costs per patient, high quality, availability and the continuous immunotherapy.