Zhou Vivienne Yuetong, Lacaille Diane, Zheng Yufei, Qian Yi, Nosyk Bohdan, Xie Hui
Arthritis Research Canada, 2238 Yukon St #230, Vancouver, BC, V5Y 3P2, Canada.
Faculty of Health Sciences, Simon Fraser University, 8888 University Dr W, Burnaby, BC, V5A 1S6, Canada.
Lancet Reg Health Am. 2025 Apr 11;45:101058. doi: 10.1016/j.lana.2025.101058. eCollection 2025 May.
Epidemiological evidence on biosimilars' real-world performance is limited. On July 18th, 2017, a biosimilar health policy was implemented in British Columbia (BC), Canada, mandating all patients initiating a new biologic medication to be prescribed a biosimilar (if/when available). Exploiting a policy change as a natural experiment, we assessed the real-world impact of biosimilar use for inflammatory arthritis (IA) on health resource utilization as a surrogate marker of real-world effectiveness and safety.
Using administrative health data, we identified all incident etanercept users for IA in BC with initiation dates between 2014 and 2020 (n = 3004) [63·6% female; mean (S.D.) age at IA disease diagnosis 52·5 (16·6) years]. Healthcare utilization over three years after initiation was assessed using outcomes including - physician visits (PV), all-cause hospitalizations (ACH), infection-related hospitalizations (IRH), length of hospital stays (LOS), and emergency room visits (ERV). Using regression discontinuity design, we compared healthcare utilization risk in patients initiating etanercept immediately before/after policy-change date, representing the intention-to-treat effect. Additionally, we estimated the complier average causal effect of biosimilar use with instrumental variable (IV) control function method.
Intention-to-treat analyses showed no significant impact of biosimilar policy implementation on PV, HOSP, IRH, LOS, or ERV, with respective adjusted RRs of 0·96 (95% CI: 0·82-1·12), 0·84 (95% CI: 0·49-1·44), 0·91 (95% CI: 0·21-3·86), 0·94 (95% CI: 0·41-2·15), and 0·91 (95% CI: 0·44-1·88). IV analyses indicated biosimilar use in routine settings did not significantly change healthcare utilization, compared to originator etanercept.
No significant impact of biosimilar policy or actual biosimilar use on healthcare utilization was observed, suggesting equivalent real-world effectiveness and safety of biosimilars to originators and no unintended consequences of the policy change.
CHIR and NSERC.
关于生物类似药实际应用效果的流行病学证据有限。2017年7月18日，加拿大不列颠哥伦比亚省（BC）实施了一项生物类似药健康政策，规定所有开始使用新生物制剂的患者都应开具生物类似药（如有）。利用这一政策变化作为自然实验，我们评估了生物类似药用于治疗炎性关节炎（IA）对健康资源利用的实际影响，以此作为实际有效性和安全性的替代指标。
利用行政健康数据，我们确定了2014年至2020年期间在BC省所有新确诊的IA患者中开始使用依那西普的患者（n = 3004）[女性占63.6%；IA疾病诊断时的平均（标准差）年龄为52.5（16.6）岁]。使用包括门诊就诊（PV）、全因住院（ACH）、感染相关住院（IRH）、住院时间（LOS）和急诊就诊（ERV）等结果评估开始使用依那西普后三年的医疗保健利用情况。使用回归断点设计，我们比较了在政策变更日期之前/之后立即开始使用依那西普的患者的医疗保健利用风险，代表意向性治疗效果。此外，我们使用工具变量（IV）控制函数法估计了生物类似药使用的依从者平均因果效应。
意向性治疗分析显示，生物类似药政策实施对PV、HOSP、IRH、LOS或ERV没有显著影响，调整后的相对风险分别为0.96（95%CI：0.82 - 1.12）、0.84（95%CI：0.49 - 1.44）、0.91（95%CI：0.21 - 3.86）、0.94（95%CI：0.41 - 2.15）和0.91（95%CI：0.44 - 1.88）。IV分析表明，与原研依那西普相比，在常规环境中使用生物类似药并没有显著改变医疗保健利用情况。
未观察到生物类似药政策或实际使用生物类似药对医疗保健利用有显著影响，这表明生物类似药在实际应用中的有效性和安全性与原研药相当，且政策变更没有产生意外后果。
CHIR和NSERC。
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