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)

Aims and background. Italy is divided into 20 regions. As a consequence of local au tonomy, following marketing authorization by the Italian Medicines Agency, each drug for hospital use is not immediately available, because its approval needs to un dergo further steps that can be different among regions. The Italian Society of Med ical 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-can cer drugs among patients treated in different Italian regions. Methods. The availability of 8 new anti-cancer drugs at a regional level and the co herence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency were analyzed as of April 2009. Results. Fourteen regions and autonomous province of Trento have a regional phar maceutical formulary. In most cases, the regional pharmaceutical formularies in clude the eight analyzed drugs, with therapeutic indications coherent with national marketing authorization indications. Five drugs (bevacizumab, trastuzumab, ritux imab, erlotinib, sunitinib) were included in all the existing regional pharmaceutical formularies, without restrictions, whereas three drugs (cetuximab, sorafenib, peme trexed) 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