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A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Aims

There are concerns that biosimilar erythropoiesis-stimulating agents (ESAs) are less effective than the originator ESAs. The objective of our study was to investigate differences between originator and biosimilar ESA utilisation based on defined daily doses (DDD), doses upon switching, differences between short- and long-acting ESAs and prescribed daily doses (PDD) of either ESA in ambulatory patients with renal anaemia undergoing chronic maintenance haemodialysis [chronic kidney disease (CKD) stage 5].

Methods

Patients with CKD stage 5 and specific pharmacotherapy with ESAs for at least six 3-month periods (accounting quarters) were selected from a population-based database of accounting information of Bavarian physicians and pharmacy claims data (January 2008 to December 2010). The DDD was used to determine mean ESA consumption. Descriptive statistics were used to describe the results.

Results

In our study, 6,177 CKD stage 5 patients received ESAs for ≥6 accounting quarters, of whom 64.4 % received originator ESAs, 21.1 % received biosimilars and 14.6 % received any sequence originator and biosimilar (total of 35.7 % any biosimilar). Patients receiving either originator short-acting ESAs, long-acting darbepoetin-alfa or M-PEG epoetin-beta had a median DDD consumption of 0.77, 0.81 and 0.90, respectively. Patients receiving a biosimilar short-acting ESA had a median DDD consumption of 0.82. Doses were not increased when the therapy was switched from the originator to the biosimilar ESA. These results were confirmed in 1,886 patients receiving a continuous prescription over 12 accounting quarters, with patients receiving short-acting originator ESAs, long-acting darbepoetin-alfa and biosimilar ESAs having a median daily DDD consumption of 0.80, 0.86 and 0.81, respectively.

Conclusions

We conclude that, based on a population based analysis, ESA consumption of patients on chronic haemodialysis is similar for biosimilar and originator ESAs.

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Acknowledgements

This data analysis has been a part of the PHARAO (objective drug utilisation analysis/Objektive Arzneimittelanalysen) project of the Bavarian statutory health insurance physician’s association. We would like to acknowledge the pharmaceutical contribution of Larissa Gampert and the valuable help of Nadine Stryewski with the project management.

Conflict of interest/Disclosure

The efforts for this study, which go beyond the core tasks of the Bavarian statutory health insurance physician’s association, were financially covered by Hexal (Epoetin alfa Hexal®), Medice (Abseamed®) and Sandoz (Binocrit®). All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that Peter Bramlage, Joerg Hasford and Reinhard Brunkhorst had support from the KV Bayern for the submitted work. There were no financial relationships with any organisations that might have an interest in the submitted work in the previous 3 years and no other relationships or activities that could appear to have influenced the submitted work.

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Authors and Affiliations

  1. Kassenärztliche Vereinigung Bayerns, Elsenheimerstr. 39, 80687, Munich, Germany

    Franziska Hörbrand & Johann Fischaleck

  2. Institut für Pharmakologie und präventive Medizin, Mahlow, Germany

    Peter Bramlage

  3. Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, LMU München, Munich, Germany

    Joerg Hasford

  4. Klinikum Hannover Oststadt, Hannover, Germany

    Reinhard Brunkhorst

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  1. Franziska Hörbrand
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  2. Peter Bramlage
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  3. Johann Fischaleck
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  4. Joerg Hasford
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  5. Reinhard Brunkhorst
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Correspondence to Franziska Hörbrand.

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Hörbrand, F., Bramlage, P., Fischaleck, J. et al. A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol 69, 929–936 (2013). https://doi.org/10.1007/s00228-012-1412-5

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  • DOI: https://doi.org/10.1007/s00228-012-1412-5

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