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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.
Marcianò, Ilaria; Ingrasciotta, Ylenia; Giorgianni, Francesco; Bolcato, Jenny; Chinellato, Alessandro; Pirolo, Roberta; Di Giorgio, Annalisa; Manna, Sonia; Ientile, Valentina; Gini, Rosa; Santarpia, Mariacarmela; Genazzani, Armando A; Uomo, Ilaria; Pastorello, Maurizio; Pollina Addario, Sebastiano W; Scondotto, Salvatore; Cananzi, Pasquale; Da Cas, Roberto; Traversa, Giuseppe; Rossi, Mariangela; Sottosanti, Laura; Caputi, Achille P; Trifirò, Gianluca.
Afiliação
  • Marcianò I; Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Ingrasciotta Y; Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Giorgianni F; Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Bolcato J; Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy.
  • Chinellato A; Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy.
  • Pirolo R; Pharmaceutical Service, Local Health Authority (ULSS9), Treviso, Italy.
  • Di Giorgio A; Caserta-1 Local Health Service, Caserta, Italy.
  • Manna S; Caserta-1 Local Health Service, Caserta, Italy.
  • Ientile V; Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Gini R; Agenzia Regionale di Sanità della Toscana, Florence, Italy.
  • Santarpia M; Medical Oncology, Department of Human Pathology, University of Messina, Messina, Italy.
  • Genazzani AA; Department of Pharmaceutical Sciences, "A. Avogadro" University, Novara, Italy.
  • Uomo I; Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy.
  • Pastorello M; Department of Pharmacy, Palermo Local Health Unit, Palermo, Italy.
  • Pollina Addario SW; Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy.
  • Scondotto S; Department of Epidemiologic Observatory, Health Department of Sicily, Palermo, Italy.
  • Cananzi P; Sicilian Regional Centre of Pharmacovigilance, Servizio 7-Farmaceutica, Health Department of Sicily, Palermo, Italy.
  • Da Cas R; Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy.
  • Traversa G; Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy.
  • Rossi M; Health-Unit for Pharmaceutical Governance, Umbria Region, Perugia, Italy.
  • Sottosanti L; Italian Medicines Agency (AIFA), Rome, Italy.
  • Caputi AP; Unit of Clinical Pharmacology, A.O.U. Policlinico "G. Martino", Messina, Italy.
  • Trifirò G; Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Via Consolare Valeria, 98125, Messina, Italy.
BioDrugs ; 30(4): 295-306, 2016 Aug.
Article em En | MEDLINE | ID: mdl-27138636
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.
Assuntos

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Padrões de Prática Médica / Fator Estimulador de Colônias de Granulócitos / Uso de Medicamentos / Medicamentos Biossimilares / Filgrastim Tipo de estudo: Observational_studies / Prognostic_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2016 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Padrões de Prática Médica / Fator Estimulador de Colônias de Granulócitos / Uso de Medicamentos / Medicamentos Biossimilares / Filgrastim Tipo de estudo: Observational_studies / Prognostic_studies Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2016 Tipo de documento: Article