title: Disparity in the "time to patient access" to new anti-cancer drugs in Italian regions. Results  of a survey conducted by the Italian Society  of Medical Oncology (AIOM).
abstract: OBJECTIVE
  In 2009, the Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of regional pharmaceutical formularies on the disparity of access to eight new drugs among cancer patients treated in Italian regions. The survey documented some regional restrictions for some anti-cancer drugs. In the study, we analyzed the "time to patient access" to new anti-cancer drugs in Italian regions.
  
  
  METHODS
  In March 2010, we analyzed the availability of 17 new anti-cancer drugs at a regional level, specifically the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency (AIFA). In the regions with pharmaceutical formularies, we analyzed the characteristics of technical-scientific committees for the evaluation of inclusion of hospital drugs in these formularies. We also analyzed the time from EMA (CMPH) authorization to AIFA marketing authorization, the time from AIFA marketing authorization to patient availability, and the total time from EMA (CMPH) authorization to patient availability of the drugs in all Italian regions, for 11 of these drugs.
  
  
  RESULTS
  Some drugs were included in all the regional pharmaceutical formularies, without restrictions, whereas other drugs were not included in one and others were not included in more than one formulary. Median time from EMA to AIFA was 11.2 months (range, 2.9-17.1). Median time from AIFA to patient availability was 1.4 months (range, 0.0-50.5) in regions with drug formularies versus 0.0 months in regions without drugs formularies. Median total time from EMA to patient availability was longer in regions with formularies (13.3 months; range, 2.9-65.3) than in regions without formularies (11.2 months; range, 2.9-24.0), where drugs are immediately available after AIFA marketing authorization. Moreover, the interval was very long (range, 2.9-65.3) for some drugs in regions with formularies.
  
  
  CONCLUSIONS
  The analysis confirmed that the presence of multiple hierarchical levels of drug evaluation can create disparity in drug availability for Italian citizens.
authors: 1Medical Oncology, SM della Misericordia Hospital, Azienda Ospedaliera, Perugia, Italy. stefania.gori@tin.it
authors: Stefania
authors: S
authors: Gori
authors: Massimo
authors: M
authors: Di Maio
authors: Carmine
authors: C
authors: Pinto
authors: Oscar
authors: O
authors: Alabiso
authors: Editta
authors: E
authors: Baldini
authors: Enrico
authors: E
authors: Barbato
authors: Giordano Domenico
authors: GD
authors: Beretta
authors: Stefano
authors: S
authors: Bravi
authors: Orazio
authors: O
authors: Caffo
authors: Luciano
authors: L
authors: Canobbio
authors: Francesco
authors: F
authors: Carrozza
authors: Saverio
authors: S
authors: Cinieri
authors: Giorgio
authors: G
authors: Cruciani
authors: Angelo
authors: A
authors: Dinota
authors: Vittorio
authors: V
authors: Gebbia
authors: Lucio
authors: L
authors: Giustini
authors: Claudio
authors: C
authors: Graiff
authors: Annamaria
authors: A
authors: Molino
authors: Antonio
authors: A
authors: Muggiano
authors: Giuliano
authors: G
authors: Pandoli
authors: Fabio
authors: F
authors: Puglisi
authors: Pierosandro
authors: P
authors: Tagliaferri
authors: Silverio
authors: S
authors: Tomao
authors: Marco
authors: M
authors: Venturini
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D019538:Health Care Surveys; D006297:Health Services Accessibility / Q000706:statistics & numerical data*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008495:Medical Oncology; D012955:Societies, Medical; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents