EFPIA denounces Italian decision to reimburse off-label Avastin

The Italian Medicines Agency approved reimbursement for the off-label use of Avastin bevacizumab in age-related macular degeneration (AMD). The agency said Avastin's use in the indication should be reserved to specialized eye care centers and that patients must sign a consent form.

In response, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said it was "concerned about efforts by EU Member States creating secondary, national marketing authorizations for economic reasons that undermine the EU regulatory framework and could potentially put patients at risk." The agency said Italy's decision "questions the European Commission's competence to authorize new medicines," noting that pharma companies might be discouraged from developing new innovative medicines if other cheaper medicines will be favored by regulators. ...