Primary question: How has the utilization of BCG, and other intravesical agents, for the treatment of nonmuscle invasive bladder cancer changed since the BCG shortage?

Bacillus Calmette-Guérin (BCG) is considered the gold standard first line therapy for high grade nonmuscle invasive bladder cancer. In January 2019 Merck, the sole manufacturer of BCG, announced severe shortages in the supply of BCG that subsequently limited the availability of this therapy in practice.

In cooperation with Verana Health (San Francisco, California), we sought to evaluate the impact of the BCG shortages on the utilization of BCG within urology practices in the United States. Using the AUA Quality (AQUA) Registry data, and analyzing 72 practices from March 20, 2018, to January 20, 2020, we found a dramatic decrease in BCG utilization nationwide after the shortage happened.

Figure 1. Average procedures per practice per day before and after announcement of BCG shortage.

Figure 2. Total procedures before and after announcement of BCG shortage.

As such, there was a 66.9% decrease in BCG utilization following the release of the notice from Merck. In addition, there was a 39.0% increase in the utilization of gemcitabine and a 475.2% increase in mitomycin C–alternative therapies for nonmuscle invasive bladder cancer that are typically not used as first line treatments. These findings demonstrate the value of an ongoing, prospective, longitudinal registry for characterizing trends in the delivery of urological care across the United States.

Verana Health is the data and technology partner for the AQUA Registry. Verana Health partners with leading medical associations to transform clinical data into actionable real-world evidence. These partnerships enable Verana to harness the comprehensive data found in qualified clinical data registries and other specialty data sources to accelerate medical research and enhance patient care. Learn more at veranahealth.com.