title: Impact of Guidance on the Prescription Patterns of G-CSFs for the Prevention of Febrile Neutropenia Following Anticancer Chemotherapy: A Population-Based Utilization Study in the Lazio Region.
abstract: BACKGROUND
  Current guidelines recommend prophylaxis with granulocyte colony-stimulating factors (G-CSFs) for patients with cancer who are at greater risk of febrile neutropenia (FN) while receiving chemotherapy. G-CSF biosimilars are available and represent a savings opportunity; however, their uptake has thus far been low.
  
  
  OBJECTIVE
  Our objective was to evaluate prescribing patterns for G-CSFs in the prevention of chemotherapy-related FN and to evaluate the impact of regional guidance on G-CSF prescription.
  
  
  METHODS
  We conducted an observational drug-utilization study in the Lazio region of Italy using the Electronic Therapeutic Plan Registry, which collects information on G-CSF prescriptions reimbursed by the regional health service. This registry includes information on demographics, tumour, indication for G-CSF use and previous G-CSF exposure. All therapeutic plans (TPs) registered from 1 July 2015 to 30 June 2016 were selected. A pharmaceutical policy intervention was implemented in November 2015. We evaluated temporal trends regarding G-CSF substances and compared the frequency of TPs for each G-CSF substance during the pre- and post-intervention periods.
  
  
  RESULTS
  A total of 7082 TPs were eligible for the analysis, corresponding to 6592 patients. The frequency of TPs prescribed after the intervention indicated a significant increase in the use of a filgrastim biosimilar (% difference: 14.4; p < 0.001) and significant decreases in the use of lenograstim (% difference: -6.0; p < 0.001) and pegfilgrastim (% difference: -7.8; p < 0.001). The temporal trends analysis showed an increase in TPs using a filgrastim biosimilar (from 34.4% in July 2015 to 49.8% in June 2016; p < 0.0001) and a decrease in TPs using lenograstim and pegfilgrastim.
  
  
  CONCLUSIONS
  This study shows it is possible to change attitudes towards the prescription of less expensive G-CSFs in the FN setting when the prescriber's decision-making processes are supported by evidence that includes both regulatory and clinical information and the analysis of clinical practice data.
authors.affiliation: Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00147, Rome, Italy. f.trotta@deplazio.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Trotta
authors.affiliation: Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00147, Rome, Italy.
authors.forename: Flavia
authors.initials: F
authors.lastname: Mayer
authors.affiliation: Drug Policy Area, General Directorate for Health, The Lazio Region, Via Rosa Raimondi Garibaldi, 7, 00145, Rome, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Mecozzi
authors.affiliation: Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00147, Rome, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Amato
authors.affiliation: Department of Epidemiology, Lazio Regional Health Service, Via Cristoforo Colombo, 112, 00147, Rome, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Addis
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D011307:Drug Prescriptions; D004363:Drug Utilization / Q000706:statistics & numerical data; D064147:Febrile Neutropenia / Q000139:chemically induced* / Q000517:prevention & control*; D005260:Female; D000069585:Filgrastim / Q000627:therapeutic use; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D017408:Guidelines as Topic; D006801:Humans; D007558:Italy; D000078224:Lenograstim; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000078224:Lenograstim; D000069585:Filgrastim