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Does a mandatory non-medical switch from originator to biosimilar etanercept lead to increase in healthcare use and costs? A Danish register-based study of patients with inflammatory arthritis
  1. Bente Glintborg1,2,
  2. Rikke Ibsen3,
  3. Rebecca Elisabeth Qwist Bilbo4,
  4. Merete Lund Hetland1,2 and
  5. Jakob Kjellberg4
  1. 1DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopedics, Rigshospitalet, Kobenhavn, Denmark
  2. 2Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Kobenhavn, Denmark
  3. 3i2minds, Aarhus, Denmark
  4. 4The Danish Centre for Social Science Research, Copenhagen, Denmark
  1. Correspondence to Dr Bente Glintborg; glintborg{at}


Objectives 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.

Methods 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.

Results 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.

Conclusion We demonstrated no obvious changes in overall use and costs of healthcare services following switch from originator to biosimilar etanercept.

  • biological DMARDs
  • outcomes research
  • rheumatoid arthritis
  • axial spondyloarthritis
  • psoriatic arthritis
  • anti-TNF

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  • Contributors RI and JK performed analysis of raw data. BG contributed interpretation of data from DANBIO. All authors contributed to study design, interpretation of results and the preparation of manuscript.

  • Funding The study was partly funded by Pfizer, who had no access to raw data and had no influence on the preparation of this manuscript or on the decision to publish these data.

  • Competing interests BG: Abbvie, Biogen, Pfizer. MH: Abbvie, Biogen, BMS, CellTrion, MSD, Novartis, Orion, Pfizer, Samsung, UCB. JK: Novo Nordisk, Pfizer, Roche, Celgene.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

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