Association of Patient, Disease, and Socioeconomic Characteristics With Receipt of Intravesical Bacillus Calmette-Guérin Therapy From 2002-2017 and the Impact of BCG Supply Shortages.

OBJECTIVE

To examine characteristics associated with bacillus Calmette-Guerin (BCG) receipt and the impact of supply shortages on BCG utilization and potential healthcare disparities, given global supply shortages have strained access since 2012.

METHODS

We analyzed 16,958 adults ≥66 years with newly diagnosed high-grade non-muscle invasive bladder cancer from 2002-2017 using SEER-Medicare. We examined the associations of baseline characteristics and 3 supply shortage events (in 2012, 2014, and 2017) with BCG receipt using multivariable regression, interrupted time series (ITS) analysis, and regression discontinuity analyses.

RESULTS

BCG receipt increased from 37% in 2002 to 60% in 2017 in eligible patients. Overall, in multivariable analyses, later diagnosis year, higher income and education status, higher T stage, and higher annual surgeon TURBT volume were associated with increased likelihood of BCG receipt, while older age, single/widowed/divorced status, higher Charlson comorbidity index (CCI), and current/former smoking status were associated with lower likelihood. ITS and regression discontinuity analyses showed sustained growth in BCG utilization that was minimally impacted by supply shortages, aside from a significant growth acceleration after the 2014 shortage. Effect modification analyses demonstrated no consistent associations of patient or socioeconomic characteristics with supply shortage events to suggest a differential impact among specific subgroups.

CONCLUSION

From 2002 to 2017, BCG utilization for high-risk NMIBC significantly increased from 37% to 60%, with minimal impact from supply shortages. While baseline characteristics influenced BCG receipt, there was no consistent evidence that BCG supply shortages exacerbated existing disparities.