A prospective assesment of attitudes and experiences among urologists regarding off label use of bcg vaccine in Serbia

Abstract

Objectives: To assess current attitudes of urologists to „off-label“ prescribing of BCG vaccine for high grade non-muscle invasive bladder cancer (NMIBC) and carcinoma-in-situ (CIS), as well as to perform a pharmacoeconomic evaluation of BCG vaccine manufactured by local pharmaceutical company. Methods: The attitudes and experiences of urologists regarding „off-label“ use of BCG vaccine for intravesical immunotherapy of bladder cancer, have been evaluated by using non-probability snowball sampling technique and specifically designed question- naire. Clinical, social, economic, ethical and regulatory factors have been included. Snowball sampling has involved urologists from ten different hospitals in the Northern, Central and Southern Serbia, greatly experienced in intravesical BCG immunotherapy. Results: BCG is used for intravesical immunotherapy, and has become the standard care for NMIBC and CIS. BCG therapy may reduce the risk of tumour progression, appearing to be better in preventing recurrences compared to chemotherapy, but with significantly more side effects. „Off-label“ use is the use of a medicinal product for another indication, another patient group, another dose or by another route of administration as indicated in the package insert. It was noted that BCG was in the „off-label” use in a 50,0% hospitals which had a problem with purchase of BCG for immunotherapy (regarding worldwide shortages). It was estimated that there were 1095 patients with bladder cancer in Serbia per year. The model according to which 18 vials of domestic BCG vaccine are used for immu- notherapy per patient per year, projected the net budget savings of 593 862.30 € per year. Conclusions: This research could support the further clinical studies of BCG vaccine of local manufacturer, for new indications (NMIBC and CIS). That would enable lower costs per patient, higher quality, availability and the continuous supply of immunotherapy.