TY - JOUR
T1 - Differences in the availability of new anti-cancer drugs for Italian patients treated in different regions. Results of analysis conducted by the Italian Society of Medical Oncology (AIOM)
AU - Gori, Stefania
AU - Di Maio, Massimo
AU - Pinto, Carmine
AU - Alabiso, Oscar
AU - Baldini, Editta
AU - Beretta, Giordano Domenico
AU - Caffo, Orazio
AU - Caroti, Cinzia
AU - Crinò, Lucio
AU - De Laurentiis, Michelino
AU - Dinota, Angelo
AU - Di Vito, Francesco
AU - Gebbia, Vittorio
AU - Giustini, Lucio
AU - Graiff, Claudio
AU - Guida, Michele
AU - Lelli, Giorgio
AU - Lombardo, Marco
AU - Muggiano, Antonio
AU - Puglisi, Fabio
AU - Romito, Sante
AU - Salvagno, Luigi
AU - Tagliaferri, Pierosandro
AU - Terzoli, Edmondo
AU - Venturini, Marco
PY - 2010/11
Y1 - 2010/11
N2 - Aims and background. Italy is divided into 20 regions. As a consequence of local autonomy, following marketing authorization by the Italian Medicines Agency, each drug for hospital use is not immediately available, because its approval needs to undergo further steps that can be different among regions. The Italian Society of Medical Oncology conducted the present study to describe the impact of the existence of sub-national pharmaceutical formularies on the disparity of access to new anti-cancer drugs among patients treated in different Italian regions. Methods. The availability of 8 new anti-cancer drugs at a regional level and the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency were analyzed as of April 2009. Results. Fifteen regions and autonomous province of Trento have a regional pharmaceutical formulary. In most cases, the regional pharmaceutical formularies include the eight analyzed drugs, with therapeutic indications coherent with national marketing authorization indications. Five drugs (bevacizumab, trastuzumab, rituximab, erlotinib, sunitinib) were included in all the existing regional pharmaceutical formularies, without restrictions, whereas three drugs (cetuximab, sorafenib, pemetrexed) were found to have restrictions in some regions. Conclusions. The presence of multiple hierarchical levels of drug evaluation creates a potential element of disparity in the access to pharmacological therapies for Italian citizens. Free full text available at www.tumorionline.it.
AB - Aims and background. Italy is divided into 20 regions. As a consequence of local autonomy, following marketing authorization by the Italian Medicines Agency, each drug for hospital use is not immediately available, because its approval needs to undergo further steps that can be different among regions. The Italian Society of Medical Oncology conducted the present study to describe the impact of the existence of sub-national pharmaceutical formularies on the disparity of access to new anti-cancer drugs among patients treated in different Italian regions. Methods. The availability of 8 new anti-cancer drugs at a regional level and the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency were analyzed as of April 2009. Results. Fifteen regions and autonomous province of Trento have a regional pharmaceutical formulary. In most cases, the regional pharmaceutical formularies include the eight analyzed drugs, with therapeutic indications coherent with national marketing authorization indications. Five drugs (bevacizumab, trastuzumab, rituximab, erlotinib, sunitinib) were included in all the existing regional pharmaceutical formularies, without restrictions, whereas three drugs (cetuximab, sorafenib, pemetrexed) were found to have restrictions in some regions. Conclusions. The presence of multiple hierarchical levels of drug evaluation creates a potential element of disparity in the access to pharmacological therapies for Italian citizens. Free full text available at www.tumorionline.it.
KW - Anticancer drugs
KW - Disparity
KW - Reimbursement
UR - http://www.scopus.com/inward/record.url?scp=79551496296&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79551496296&partnerID=8YFLogxK
M3 - Article
C2 - 21388067
AN - SCOPUS:79551496296
VL - 96
SP - 1010
EP - 1015
JO - Tumori
JF - Tumori
SN - 0300-8916
IS - 6
ER -