Treatment Patterns for Non-muscle Invasive Bladder Cancer During the Bacillus Calmette-Guerin Shortage.

OBJECTIVE

To evaluate the trends in the use of Bacillus Calmette-Guerin (BCG) and other intravesical agents in the management of risk non-muscle invasive bladder cancer (NMIBC) during times of BCG shortage.

METHODS

Using Surveillance, Epidemiology and End Results (SEER)-Medicare data, we conducted a retrospective study of patients diagnosed with NMIBC between 2005 and 2014, with follow-up claims through 2015. We used multinomial generalized logistic regression with clustered robust standard errors to predict quarterly, case-mix adjusted probabilities of treatment. We adjusted for age, sex, race, marital status, education, population, urban residence, income, region, comorbidities, and tumor grade. We used an interrupted time series with staggered implementation for these case-mix adjusted probabilities to examine trends before and during BCG shortages between June 2012 and August 2014.

RESULTS

We identified 24,410 patients, 16,559 of whom received BCG as their first treatment during the study period. Following the first known BCG shortage in 2012, the case-mix adjusted probability of BCG treatment was unchanged. Immediately following the second known BCG shortage in 2014, the case-mix adjusted probability of BCG decreased by 0.072 (95% Confidence Interval [-0.111, -0.333]) with a sustained trend that remained constant.

CONCLUSION

The use of BCG and other intravesical agents for the management of NMIBC remained unchanged after the first known BCG shortage in 2012. The probability of BCG treatment decreased slightly after the second shortage in 2014. Further investigation is warranted to assess the impact of this on oncologic outcomes and disease progression.