[Avastin-Lucentis: off-label and surroundings]

In Italy, the debate on the off-label use of intravitreal bevacizumab in patients with age-related macular degeneration (AMD) has attracted a very wide coverage by the media. Our national regulation on the off-label uses of pharmacological agents was initially issued in 1999 to handle the case of the so-called "Di Bella therapy" in patients with cancer. Some changes to this regulation have been made thereafter, and the most recent law currently prohibits the use of off-label agents in cases where approved medicines are available. Bevacizumab and ranibizumab are thought to be equi-effective, and also their safety profiles are similar. Since the cost per intravitreal injection is much lower for off-label bevacizumab than for ranibizumab, in our National Health System the criterion of economic savings, that favours bevacizumab, conflicts with the criterion set by the current regulation that instead favours ranibizumab. Therefore, a lively debate has been started and is still ongoing to establish how the present regulation in this area can be revised. In devising the new regulation on this issue, one point deserving consideration is that the case of bevacizumab vs ranibizumab in patients with AMD is very atypical in the current scenario of in-hospital drug treatments. Hence, the new regulation should be tailored to the therapeutic needs of all patients likely to receive an off-label treatment for any clinical indication rather than to the specific case of intravitreal treatments for patients with AMD.