title: How Much Are Biosimilars Used in Clinical Practice? A Retrospective Italian Population-Based Study of Erythropoiesis-Stimulating Agents in the Years 2009-2013.
abstract: OBJECTIVE
  To explore the prescription patterns of erythropoiesis-stimulating agents (ESAs) in four large Italian geographic areas, where different health policy interventions to promote biosimilar use in routine care are undertaken.
  
  
  METHODS
  A retrospective drug utilization study was conducted during the years 2009-2013. The data sources were the administrative databases of the Tuscany region and of the Caserta, Palermo, and Treviso Local Health Units (LHUs). The characteristics, prevalence, and switching patterns of different ESAs (biosimilars and reference products), stratified by indication for use, were calculated over time and across centers.
  
  
  RESULTS
  Overall, 49,491 patients were treated with ESAs during the years 2009-2013 in the four centers. Of these, 41,286 patients (83.4 %) were naive users. The prevalence of ESA use increased from 2.9 to 3.4 per 1000 inhabitants in the years 2009-2011 but decreased thereafter (3.0 per 1000 in 2013). Moreover, the proportion of biosimilar users increased overall from 1.8 % in 2010 to 33.6 % in 2013, with larger increase in Treviso (from 0.0 to 45.0 %) and Tuscany (from 0.7 to 37.6 %) than in Caserta (from 7.5 to 22.9 %) and Palermo (from 0.0 to 27.7 %). Switching between different ESAs during the first year of therapy was frequent (17.0 %), much more toward reference products than toward biosimilars.
  
  
  CONCLUSIONS
  Overall, the prevalence of ESA use decreased slightly, while use of biosimilar ESAs, especially in naive patients, increased significantly but to different extents in these four large Italian geographic areas. Switching between different ESAs during the first year of treatment was very frequent, which may affect pharmacovigilance monitoring. New strategies are necessary to further improve market penetration of low-cost medicines, such as biosimilars, and also to harmonize effective health policy interventions that aim to reduce pharmaceutical expenses and optimize patient benefit across all regions.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy, ylenia.ingrasciotta@unime.it.
authors.forename: Ylenia
authors.initials: Y
authors.lastname: Ingrasciotta
authors.forename: Francesco
authors.initials: F
authors.lastname: Giorgianni
authors.forename: Jenny
authors.initials: J
authors.lastname: Bolcato
authors.forename: Alessandro
authors.initials: A
authors.lastname: Chinellato
authors.forename: Roberta
authors.initials: R
authors.lastname: Pirolo
authors.forename: Daniele Ugo
authors.initials: DU
authors.lastname: Tari
authors.forename: Chiara
authors.initials: C
authors.lastname: Troncone
authors.forename: Andrea
authors.initials: A
authors.lastname: Fontana
authors.forename: Valentina
authors.initials: V
authors.lastname: Ientile
authors.forename: Rosa
authors.initials: R
authors.lastname: Gini
authors.forename: Domenico
authors.initials: D
authors.lastname: Santoro
authors.forename: Mariacarmela
authors.initials: M
authors.lastname: Santarpia
authors.forename: Armando
authors.initials: A
authors.lastname: Genazzani
authors.forename: Ilaria
authors.initials: I
authors.lastname: Uomo
authors.forename: Maurizio
authors.initials: M
authors.lastname: Pastorello
authors.forename: Walter Sebastiano Pollina
authors.initials: WS
authors.lastname: Addario
authors.forename: Salvatore
authors.initials: S
authors.lastname: Scondotto
authors.forename: Pasquale
authors.initials: P
authors.lastname: Cananzi
authors.forename: Achille Patrizio
authors.initials: AP
authors.lastname: Caputi
authors.forename: Gianluca
authors.initials: G
authors.lastname: Trifirò
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage* / Q000627:therapeutic use; D016208:Databases, Factual; D005260:Female; D006291:Health Policy; D006397:Hematinics / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D060735:Pharmacovigilance; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D012189:Retrospective Studies
chemical_list: D059451:Biosimilar Pharmaceuticals; D006397:Hematinics