Nabi Hafsah, Ibsen Rikke, Ibsen Michael, Kjellberg Jakob, Hetland Merete Lund, Glintborg Bente
DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Copenhagen University Hospital Rigshospitalet, Valdemar Hansens Vej 17, Glostrup 2600, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Ther Adv Musculoskelet Dis. 2024 Oct 16;16:1759720X241289391. doi: 10.1177/1759720X241289391. eCollection 2024.
In Denmark, cost savings motivate mandatory biosimilar switches. In 2018, patients switched from originator to biosimilar adalimumab, that is, to GP2017 in Eastern and to SB5 in Western Denmark. However, concerns were raised about additional costs covering, that is, an increased number of outpatient visits due to patient education, treatment monitoring, and patient concerns.
To investigate whether the switch led to increased total healthcare costs, defined as costs related to in- and outpatient contacts in hospitals and the primary sector and use of prescription medicine (excluding biological treatment).
Observational cohort study with geographical cluster pseudo-randomization.
Patients with rheumatoid arthritis, psoriatic arthritis (PsA), and axial spondyloarthritis (AxSpA), who switched were identified in the nationwide DANBIO registry. Total healthcare costs 9 months before and after the switch were captured from the National Patient and Prescription registries. The difference between pre- and post-switch costs was estimated by a generalized estimation equations (GEE) model.
Overall, 1316 patients switched to GP2017 ( = 621) or SB5 ( = 695). Total healthcare costs were mainly driven by hospital costs. The monthly fluctuations of hospital costs 9 months before and after the switch were largely similar or decreased. In the adjusted analyses (GEE), hospital costs decreased after the switch (by approximately 15%) for GP2017 switchers, especially PsA (estimate = 0.83; 95% CI 0.75-0.92) and AxSpA patients (estimate = 0.85; 0.77-0.93), with no significant changes for SB5 switchers.
We found no increase in total healthcare costs in 9 months following a nationwide mandatory adalimumab originator to biosimilar switch. Our findings were strengthened by similar results for GP2017 and SB5.
在丹麦，成本节约促使强制使用生物类似药进行换药。2018年，患者从原研阿达木单抗换成了生物类似药，即在丹麦东部换成了GP2017，在丹麦西部换成了SB5。然而，人们对额外费用负担表示担忧，即由于患者教育、治疗监测和患者顾虑导致门诊就诊次数增加。
调查换药是否导致总医疗费用增加，总医疗费用定义为与医院和初级医疗部门的门诊和住院接触以及处方药使用（不包括生物治疗）相关的费用。
采用地理集群伪随机化的观察性队列研究。
在全国性的DANBIO注册中心识别出换药的类风湿性关节炎、银屑病关节炎（PsA）和中轴型脊柱关节炎（AxSpA）患者。从国家患者和处方注册中心获取换药前后9个月的总医疗费用。通过广义估计方程（GEE）模型估计换药前后费用的差异。
总体而言，1316名患者换成了GP2017（n = 621）或SB5（n = 695）。总医疗费用主要由医院费用驱动。换药前后9个月医院费用的月度波动基本相似或有所下降。在调整分析（GEE）中，换成GP2017的患者换药后医院费用下降（约15%），尤其是PsA患者（估计值 = 0.83；95%置信区间0.75 - 0.92）和AxSpA患者（估计值 = 0.85；0.77 - 0.93），而换成SB5的患者则无显著变化。
我们发现在全国范围内强制将原研阿达木单抗换成生物类似药后的9个月内，总医疗费用没有增加。GP2017和SB5的类似结果进一步支持了我们的发现。
