Ilaria Marcianò1, Ylenia Ingrasciotta1, Francesco Giorgianni1, Jenny Bolcato2, Alessandro Chinellato2, Roberta Pirolo2, Annalisa Di Giorgio3, Sonia Manna3, Valentina Ientile1, Rosa Gini4, Mariacarmela Santarpia5, Armando A Genazzani6, Ilaria Uomo7, Maurizio Pastorello7, Sebastiano W Pollina Addario8, Salvatore Scondotto8, Pasquale Cananzi9, Roberto Da Cas10, Giuseppe Traversa10, Mariangela Rossi11, Laura Sottosanti12, Achille P Caputi1,13, Gianluca Trifirò14,15. 1. Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy. 2. Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy. 3. Caserta-1 Local Health Service, Caserta, Italy. 4. Agenzia Regionale di Sanità della Toscana, Florence, Italy. 5. Medical Oncology, Department of Human Pathology, University of Messina, Messina, Italy. 6. Department of Pharmaceutical Sciences, "A. Avogadro" University, Novara, Italy. 7. Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy. 8. Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy. 9. Sicilian Regional Centre of Pharmacovigilance, Servizio 7-Farmaceutica, Health Department of Sicily, Palermo, Italy. 10. Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy. 11. Health-Unit for Pharmaceutical Governance, Umbria Region, Perugia, Italy. 12. Italian Medicines Agency (AIFA), Rome, Italy. 13. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Via Consolare Valeria, 98125, Messina, Italy. 14. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Via Consolare Valeria, 98125, Messina, Italy. trifirog@unime.it. 15. Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The Netherlands. trifirog@unime.it.
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.
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.
Authors: Massimo Di Maio; Paolo Bruzzi; Francesco Perrone; Valter Torri; Filippo Montemurro; Marcello Tiseo; Enrico Vasile Journal: ESMO Open Date: 2016-12-12
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Authors: Evelien Moorkens; Steven Simoens; Per Troein; Paul Declerck; Arnold G Vulto; Isabelle Huys Journal: BioDrugs Date: 2019-06 Impact factor: 5.807
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