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.
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.
Eur Urol Focus. 2021 Jan;7(1):111-116. doi: 10.1016/j.euf.2019.04.002. Epub 2019 Apr 18.
Between 2013 and 2016, global production of bacillus Calmette-Guérin (BCG) was dramatically reduced due to the collapse of the factory producing BCG Connaught.
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).
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.
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.
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.
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.
2013 年至 2016 年间，由于生产卡介苗的工厂康诺特倒闭，卡介苗的全球产量大幅下降。
评估卡介苗短缺对接受限制供应期间治疗的非肌肉浸润性膀胱癌（NMIBC）患者队列的临床和经济影响。
设计、地点和参与者：这项回顾性、前后对照、成本后果研究纳入了中高危 NMIBC 患者。将 2011 年 11 月至 2013 年 9 月期间切除的患者（对照组）与 2013 年 10 月至 2016 年 12 月期间切除的患者（研究组）进行比较。
主要终点是从经尿道切除术后 30 天到 24 个月随访结束时的肿瘤复发率；次要终点包括主要治疗的平均成本、复发治疗的平均成本以及每位患者因卡介苗短缺而产生的额外成本。
共纳入 402 例患者：对照组 191 例，研究组 211 例。研究组 24 个月时的复发率明显高于对照组（46.9%比 16.2%；相对风险：0.7，95%置信区间[0.60；0.82]；p<0.001）。由于卡介苗产量下降，预计在供应受限期间每例新诊断为 NMIBC 的患者的额外费用为 783 欧元。这是在我们科室层面进行的回顾性分析。更精确的评估需要对更大队列的患者进行研究。
2013 年 10 月至 2016 年 12 月卡介苗短缺对医疗和经济产生了重大影响；膀胱癌复发率增加，中高危 NMIBC 的整体治疗费用增加。
在本报告中，我们分析了 2013 年至 2016 年间卡介苗短缺对医疗和经济的影响。我们发现膀胱癌复发和进展的显著增加，以及需要接受膀胱切除术治疗的患者数量增加。卡介苗短缺也对总费用产生了重大影响。由于高危非肌肉浸润性膀胱癌患者没有卡介苗替代物，因此必须通过任何手段维持卡介苗的生产。
