Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers (Articolo in rivista)

Type
Label
  • Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers (Articolo in rivista) (literal)
Anno
  • 2010-01-01T00:00:00+01:00 (literal)
Alternative label
  • Russo P, Mennini FS, Siviero PD, Rasi G. (2010)
    Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers
    in Annals of oncology
    (literal)
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  • Russo P, Mennini FS, Siviero PD, Rasi G. (literal)
Pagina inizio
  • 2081 (literal)
Pagina fine
  • 2087 (literal)
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  • 2010 Oct. Epub 2010 Mar 24.PMID: 20335370 (literal)
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  • 21/10 (literal)
Rivista
Note
  • ISI Web of Science (WOS) (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#affiliazioni
  • 1 - OSMED Office, Italian Medicines Agency; 2 - CEIS Sanità (Centre for Health Economics and Management), Faculty of Economics, University ‘Tor Vergata’ Rome; 3 - Faculty of Statistics, University ‘La Sapienza’ Rome; 4 - Center for Strategic Studies, Italian Medicines Agency; 5 - Italian Medicines Agency, General Director, Italy Institute of Neurobiology and Molecular Medicine-ARTOV, CNR via Fosso del Cavaliere 100, 00133-Rome, Italy. (literal)
Titolo
  • Time to market and patient access to new oncology products in Italy: a multistep pathway from European context to regional health care providers (literal)
Abstract
  • AIM: The main purpose of this study was to identify each sequential phase followed by an oncology product, from European assessment until to patient access in each Italian region (IR). METHODS: A panel of oncology products approved by the European Medicines Agency (EMA) in the period 2006-2008 was considered. The explored sequential phases included the times to market for: the EMA; pharmaceutical companies; the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA); and IRs as final providers of health care. The IR's time to market was also analyzed by a Cox regression model. RESULTS: The overall mean time required before patients access was 2.3 years. EMA accounted for the greater proportion of time (31.8%), followed by AIFA (28.2%). However, the duration for both pharmaceutical companies and IRs was associated with the highest variability. An oncology product authorized with a risk-sharing agreement showed an early access in the IRs. On the contrary, the introduction in IRs having a compulsory formulary was delayed. Both a high forecast of economic impact and a high oncology product price can also delay the patient access. CONCLUSION: The process before patient access to an oncology product is time and cost consuming. This study identifies the main predictors that affect the missing overlap between market and patient access in Italy. (literal)
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