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How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009–2014

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Abstract

Background

Granulocyte colony-stimulating factors (G-CSFs) are biological products for which the main indication of use is chemotherapy-induced neutropenia. Biosimilars of G-CSFs have been available in Europe since 2007.

Objective

The objective of this study was to investigate the prescribing pattern of G-CSFs in five Italian centres using different healthcare policy interventions to promote the use of biosimilars in routine care.

Methods

This retrospective, population-based drug utilization study was conducted during the years 2009–2014 using the administrative databases of the Caserta, Treviso and Palermo Local Health Units (LHUs) and the Tuscany and Umbria regions. G-CSF users were characterized and the prevalence of use, proportion of biosimilar users and switching pattern of different G-CSFs were evaluated over time and across centres.

Results

Overall, 30,247 patients were treated with G-CSFs in the years 2009–2014, of which 29,083 (96.2 %) were naïve users. The overall prevalence of G-CSF use increased from 0.8 per 1000 inhabitants in 2009 to 1.1 per 1000 in 2014. An increase in the proportion of the use of the biosimilar filgrastim by the total G-CSF users was observed in all centres: from 0.2 % (2009) to 66.2 % (2014). However, heterogeneity across different centres was reported, with the largest increase in Treviso LHU (from 0 to 89.1 % from 2009 to 2014). During the first year of treatment, switching between different G-CSFs was frequent (20.3 %).

Conclusions

Heterogeneity in the use of G-CSF and, in particular, biosimilar filgrastim across different Italian centres was observed, probably due to different regional healthcare policy interventions. During the first year of treatment, switching between different G-CSFs was frequent. Considering the impact of biological drugs on pharmaceutical expenses, it is necessary to harmonize healthcare policies promoting the use of biological drugs with the lowest cost.

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Author Contributions

Study concept and design: Gianluca Trifirò, Achille P. Caputi. Acquisition of data (Caserta LHU): Annalisa Di Giorgio, Sonia Manna. Acquisition of data (Palermo LHU): Ilaria Uomo, Sebastiano W. Pollina Addario, Salvatore Scondotto. Acquisition of data (Tuscany): Rosa Gini. Acquisition of data (Treviso LHU): Alessandro Chinellato, Jenny Bolcato. Acquisition of data (Umbria LHU): Roberto Da Cas, Giuseppe Traversa, Mariangela Rossi. Acquisition of data (pharmacovigilance spontaneous reporting system): Laura Sottosanti. Data management: Francesco Giorgianni, Valentina Ientile. Analysis and interpretation of data: Ilaria Marcianò, Ylenia Ingrasciotta, Gianluca Trifirò, Mariacarmela Santarpia, Pasquale Cananzi, Maurizio Pastorello, Roberta Pirolo. Preparation of manuscript: Ilaria Marcianò, Ylenia Ingrasciotta, Gianluca Trifirò, Armando A. Genazzani, Giuseppe Traversa.

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Authors and Affiliations

  1. Unit of Clinical Pharmacology, A.O.U. Policlinico “G. Martino”, Messina, Italy

    Ilaria Marcianò, Ylenia Ingrasciotta, Francesco Giorgianni, Valentina Ientile & Achille P. Caputi

  2. Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy

    Jenny Bolcato, Alessandro Chinellato & Roberta Pirolo

  3. Caserta-1 Local Health Service, Caserta, Italy

    Annalisa Di Giorgio & Sonia Manna

  4. Agenzia Regionale di Sanità della Toscana, Florence, Italy

    Rosa Gini

  5. Medical Oncology, Department of Human Pathology, University of Messina, Messina, Italy

    Mariacarmela Santarpia

  6. Department of Pharmaceutical Sciences, “A. Avogadro” University, Novara, Italy

    Armando A. Genazzani

  7. Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy

    Ilaria Uomo & Maurizio Pastorello

  8. Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy

    Sebastiano W. Pollina Addario & Salvatore Scondotto

  9. Sicilian Regional Centre of Pharmacovigilance, Servizio 7-Farmaceutica, Health Department of Sicily, Palermo, Italy

    Pasquale Cananzi

  10. Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy

    Roberto Da Cas & Giuseppe Traversa

  11. Health-Unit for Pharmaceutical Governance, Umbria Region, Perugia, Italy

    Mariangela Rossi

  12. Italian Medicines Agency (AIFA), Rome, Italy

    Laura Sottosanti

  13. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Via Consolare Valeria, 98125, Messina, Italy

    Achille P. Caputi & Gianluca Trifirò

  14. Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The Netherlands

    Gianluca Trifirò

Authors
  1. Ilaria Marcianò
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  2. Ylenia Ingrasciotta
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  3. Francesco Giorgianni
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  4. Jenny Bolcato
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  5. Alessandro Chinellato
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  7. Annalisa Di Giorgio
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  8. Sonia Manna
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  9. Valentina Ientile
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  10. Rosa Gini
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  11. Mariacarmela Santarpia
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  12. Armando A. Genazzani
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  13. Ilaria Uomo
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  14. Maurizio Pastorello
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  15. Sebastiano W. Pollina Addario
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  16. Salvatore Scondotto
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  17. Pasquale Cananzi
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  18. Roberto Da Cas
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  19. Giuseppe Traversa
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  20. Mariangela Rossi
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  21. Laura Sottosanti
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  22. Achille P. Caputi
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  23. Gianluca Trifirò
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Corresponding author

Correspondence to Gianluca Trifirò.

Ethics declarations

Ethical Approvals

This study was conducted in the context of the “Assessment of Short and Long Term Risk–Benefit Profile of Biologics through Healthcare Database Network in Italy” project, funded by the Italian Ministry of Health. The study protocol was notified to the Ethical Committee of the Academic Hospital of Messina [26], according to the current national law. The manuscript does not contain clinical studies or patient data. For this type of study formal consent is not required.

Conflict of interest

Achille Patrizio Caputi and Gianluca Trifirò coordinate a research team at the University of Messina which receives research grants for projects that are not related to the topic of the paper. Ilaria Marcianò, Ylenia Ingrasciotta, Francesco Giorgianni, Jenny Bolcato, Alessandro Chinellato, Roberta Pirolo, Annalisa Di Giorgio, Sonia Manna, Valentina Ientile, Rosa Gini, Mariacarmela Santarpia, Armando A. Genazzani, Ilaria Uomo, Maurizio Pastorello, Sebastiano W. Pollina Addario, Salvatore Scondotto, Pasquale Cananzi, Roberto Da Cas, Giuseppe Traversa, Mariangela Rossi and Laura Sottosanti declare that they have no conflicts of interest.

Funding

This study was conducted in the context of the “Assessment of short and long term risk-benefit profile of biologics through healthcare database network in Italy” finalised research project (RF-2010-2320172), which was funded by the Italian Health Minister. The financial assistance was used to access and analyse data from different partners.

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Marcianò, I., Ingrasciotta, Y., Giorgianni, F. et al. How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009–2014. BioDrugs 30, 295–306 (2016). https://doi.org/10.1007/s40259-016-0175-4

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