EU Court Rules in Favor of Italy’s Off-Label Use of Avastin in Wet AMD

The Court of Justice of the European Union ruled Nov. 21 that Italy’s national health system can reimburse ophthalmologists for the use of off-label Avastin (bevacizumab) to treat age-related macular degeneration (AMD).

Novartis—which markets the competing product Lucentis outside the US—challenged a decision by the Italian Medicines Agency in 2014 to cover Avastin in wet AMD patients. Lucentis is approved for the indication.

The court noted in a press release that Avastin costs Italy’s national health system €82 euros per dose for use in wet AMD, while Lucentis costs €902.

It ruled that EU member states’ responsibilities include setting prices for medicinal products and deciding whether to include them in national formularies. 

The court said EU law does not prohibit off-label prescription of a product or its repackaging for such use, as long as certain conditions are met.