@conference{
author = "Marinković, Valentina and Bekcić, Stana and Đorđević, J. and Tasić, Ljiljana and Stojković, Tatjana",
year = "2016",
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.",
publisher = "Elsevier Science Inc",
journal = "Value in Health",
title = "A prospective assesment of attitudes and experiences among urologists regarding off label use of bcg vaccine in Serbia",
volume = "19",
number = "7",
pages = "A497-A498",
doi = "10.1016/j.jval.2016.09.875"
}