DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Kobenhavn, Denmark.
Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Kobenhavn, Denmark.
RMD Open. 2019 Aug 12;5(2):e001016. doi: 10.1136/rmdopen-2019-001016. eCollection 2019.
In year 2016, Danish national guidelines included a mandatory switch of patients with inflammatory rheumatic diseases treated with originator etanercept (ETA) to biosimilar SB4 in routine care. We aimed to explore if switching lead to increased healthcare utilisation and costs.
Observational cohort study. Adult patients who switched from ETA to SB4 were identified in the Danish nationwide DANBIO registry. In the National Patient Registry, we identified health utilisation (hospital admissions/hospital days/outpatient visits/prescription medication use) and comorbidities. Estimation of health utilisation included average use and costs 1 year before/after switch, changes after the switch, and whether patient characteristics affected changes. Analyses were by adjusted two-step gamma distributed regression models, and for changes over time a generalized estimation equations (GEE) model was applied. Impact of comorbidities was explored as interaction terms in the model. Medication costs of ETA and SB4 were not included in model.
1620 patients were included (mean age 55 years (SD 14.7), 40% male). Costs before and after switching were mainly driven by outpatient visits (67%/72% of all costs). Monthly fluctuations of costs were similar before/after switch. After switching, use (8%) and costs (7%) of outpatient services increased, whereas costs of admissions (55%) and medication (5%) decreased. Patients with longer ETA treatment duration had an increase in use and costs of healthcare resources, whereas gender and comorbidities had no impact. Higher age was associated with an increase in costs of inpatient services.
We demonstrated no obvious changes in overall use and costs of healthcare services following switch from originator to biosimilar etanercept.
2016 年，丹麦国家指南要求将接受依那西普（ETA）治疗的炎症性风湿病患者强制性转换为常规治疗中的生物类似药 SB4。我们旨在探讨转换是否会导致医疗保健利用和成本增加。
观察性队列研究。在丹麦全国性的 DANBIO 登记处中，确定了从 ETA 转换为 SB4 的成年患者。在国家患者登记处，我们确定了卫生利用（住院入院/住院天数/门诊就诊/处方药物使用）和合并症。健康利用的估计包括转换前后 1 年的平均使用和成本，转换后的变化，以及患者特征是否影响变化。分析采用调整后的两步伽马分布回归模型，对于随时间的变化采用广义估计方程（GEE）模型。在模型中，探索了合并症的影响作为交互项。ETA 和 SB4 的药物成本未包含在模型中。
共纳入 1620 例患者（平均年龄 55 岁[SD 14.7]，40%为男性）。转换前后的成本主要由门诊就诊（所有成本的 67%/72%）驱动。转换前后的每月成本波动相似。转换后，门诊服务的使用（8%）和成本（7%）增加，而入院（55%）和药物（5%）的成本减少。ETA 治疗持续时间较长的患者，医疗资源的使用和成本增加，而性别和合并症无影响。较高的年龄与住院服务成本的增加相关。
我们发现在从原研药转换为生物类似药依那西普后，整体医疗保健服务的使用和成本没有明显变化。
