title: 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.
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.
authors.affiliation: Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Marcianò
authors.affiliation: Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
authors.forename: Ylenia
authors.initials: Y
authors.lastname: Ingrasciotta
authors.affiliation: Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giorgianni
authors.affiliation: Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy.
authors.forename: Jenny
authors.initials: J
authors.lastname: Bolcato
authors.affiliation: Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Chinellato
authors.affiliation: Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Pirolo
authors.affiliation: Caserta-1 Local Health Service, Caserta, Italy.
authors.forename: Annalisa
authors.initials: A
authors.lastname: Di Giorgio
authors.affiliation: Caserta-1 Local Health Service, Caserta, Italy.
authors.forename: Sonia
authors.initials: S
authors.lastname: Manna
authors.affiliation: Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Ientile
authors.affiliation: Agenzia Regionale di Sanità della Toscana, Florence, Italy.
authors.forename: Rosa
authors.initials: R
authors.lastname: Gini
authors.affiliation: Medical Oncology, Department of Human Pathology, University of Messina, Messina, Italy.
authors.forename: Mariacarmela
authors.initials: M
authors.lastname: Santarpia
authors.affiliation: Department of Pharmaceutical Sciences, "A. Avogadro" University, Novara, Italy.
authors.forename: Armando A
authors.initials: AA
authors.lastname: Genazzani
authors.affiliation: Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Uomo
authors.affiliation: Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Pastorello
authors.affiliation: Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy.
authors.forename: Sebastiano W
authors.initials: SW
authors.lastname: Pollina Addario
authors.affiliation: Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Scondotto
authors.affiliation: Sicilian Regional Centre of Pharmacovigilance, Servizio 7-Farmaceutica, Health Department of Sicily, Palermo, Italy.
authors.forename: Pasquale
authors.initials: P
authors.lastname: Cananzi
authors.affiliation: Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Da Cas
authors.affiliation: Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Traversa
authors.affiliation: Health-Unit for Pharmaceutical Governance, Umbria Region, Perugia, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Rossi
authors.affiliation: Italian Medicines Agency (AIFA), Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Sottosanti
authors.affiliation: Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.|Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Via Consolare Valeria, 98125, Messina, Italy.
authors.forename: Achille P
authors.initials: AP
authors.lastname: Caputi
authors.affiliation: Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Via Consolare Valeria, 98125, Messina, Italy. trifirog@unime.it.|Department of Medical Informatics, Erasmus Medical Centre, Rotterdam, The Netherlands. trifirog@unime.it.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Trifirò
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D004363:Drug Utilization / Q000706:statistics & numerical data*; D005260:Female; D000069585:Filgrastim / Q000627:therapeutic use*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006291:Health Policy; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010818:Practice Patterns, Physicians'; D012189:Retrospective Studies
chemical_list: D059451:Biosimilar Pharmaceuticals; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim