Said Ourfali1, Robin Ohannessian2, Hakim Fassi-Fehri1, Alfreda Pages1, Lionel Badet1, Marc Colombel3. 1. Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot, Université Lyon Claude Bernard, Lyon, France; Hôpital Edouard Herriot, Hospices Civils de Lyon et Université Claude Bernard, Lyon, France. 2. Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot, Université Lyon Claude Bernard, Lyon, France; Univ. Lyon, Université Claude Bernard Lyon 1, Lyon, France. 3. Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot, Université Lyon Claude Bernard, Lyon, France; Hôpital Edouard Herriot, Hospices Civils de Lyon et Université Claude Bernard, Lyon, France. Electronic address: marc.colombel@chu-lyon.fr.
Abstract
BACKGROUND: Between 2013 and 2016, global production of bacillus Calmette-Guérin (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 < 0.001). The increased cost due to the decrease in BCG production was estimated to be €783 per patient with a new diagnosis of NMIBC during the period of restricted supply. This is a retrospective analysis at the level of our unit. A more precise evaluation would require a study of a larger cohort of patients. 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-Guérin (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.
BACKGROUND: Between 2013 and 2016, global production of bacillus Calmette-Guérin (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 < 0.001). The increased cost due to the decrease in BCG production was estimated to be €783 per patient with a new diagnosis of NMIBC during the period of restricted supply. This is a retrospective analysis at the level of our unit. A more precise evaluation would require a study of a larger cohort of patients. 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-Guérin (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.
Authors: Lauren J Lee; Christina S Kwon; Anna Forsythe; Carla M Mamolo; Elizabeth T Masters; Ira A Jacobs Journal: Clinicoecon Outcomes Res Date: 2020-11-23
Authors: Félix Guerrero-Ramos; Daniel A González-Padilla; Alejandro González-Díaz; Federico de la Rosa-Kehrmann; Alfredo Rodríguez-Antolín; Brant A Inman; Felipe Villacampa-Aubá Journal: World J Urol Date: 2022-01-17 Impact factor: 3.661
Authors: Antonín Brisuda; James C S Ho; Pancham S Kandiyal; Justin T-Y Ng; Ines Ambite; Daniel S C Butler; Jaromir Háček; Murphy Lam Yim Wan; Thi Hien Tran; Aftab Nadeem; Tuan Hiep Tran; Anna Hastings; Petter Storm; Daniel L Fortunati; Parisa Esmaeili; Hana Novotna; Jakub Horňák; Y G Mu; K H Mok; Marek Babjuk; Catharina Svanborg Journal: Nat Commun Date: 2021-06-08 Impact factor: 14.919