Recurrence Rate and Cost Consequence of the Shortage of Bacillus Calmette-Guérin Connaught Strain for Bladder Cancer Patients

Abstract Background Between 2013 and 2016, global production of bacillus Calmette-Guerin (BCG) was dramatically reduced due to the collapse of the factory producing BCG Connaught. Objective To evaluate the clinical and economic impact of BCG shortage on a cohort of non–muscle-invasive bladder cancer (NMIBC) patients treated during the period of restricted supply. Design, setting and participants This retrospective, before and after, cost-consequence study included patients with intermediate- and high-risk NMIBC. Those resected between November 2011 and September 2013 (control group) were compared with those resected between October 2013 and December 2016 (study group). Outcome measurements and statistical analysis The primary endpoint was the rate of tumor recurrence from 30 d after transurethral resection to the end of follow-up at 24 mo; the secondary endpoints included the average cost of primary treatment, average cost of treatment of recurrence, and excess cost due to BCG shortage per patient. Results and limitations A total of 402 patients were included: 191 in the control group and 211 in the study group. The rate of recurrence at 24 mo was significantly higher in the study group than in the control group (46.9% vs 16.2%; relative risk: 0.7, 95% confidence interval [0.60; 0.82]; p Conclusions The shortage of BCG between October 2013 and December 2016 had a significant medical and economic impact; there was an increased rate of bladder cancer recurrence, and the total cost of care for intermediate- and high-risk NMIBC was higher. Patient summary In this report, we analyzed the medical and economic impact of bacillus Calmette-Guerin (BCG) shortage that occurred between 2013 and 2016. We found a significant increase of bladder cancer recurrence and progression, and an increase in the number of patients who had to be treated by cystectomy. BCG shortage also had a significant impact on the total cost. Since there are no alternatives to BCG for high-risk non–muscle-invasive bladder cancer patients, BCG production has to be maintained by any means.