European Court Rules in Favor of Allowing Off-label Bevacizumab Use

This month, the Court of Justice of the European Union ruled that Italy’s national health system can reimburse for the use of bevacizumab in the treatment of eye diseases, such as age-related macular degeneration (AMD), despite the fact that bevacizumab does not have a marketing authorization for this indication.

In 2014, Italy’s medicines agency added the brand-name bevacizumab, Avastin, to the list of products for which the Italian national health service would reimburse for the treatment of AMD. Novartis, which markets an authorized anti—vascular endothelial growth factor (VEGF) treatment, ranibizumab (Lucentis), challenged Italy’s policy in the European Union’s court.

In its judgment, the court ruled that the organization and management of health services—including setting prices for products and deciding whether to include them on formularies—in EU member states are the responsibility of the member states themselves. While the court noted that member states must comply with EU law while exercising those duties, the use of bevacizumab is not itself unlawful in the European Union.

Furthermore, the court indicated that Italy’s repackaging of bevacizumab for intravitreal injections is not prohibited by EU law, and not an activity that requires a new marketing authorization. Finally, it noted that the pharmacovigilance efforts already in place for bevacizumab are sufficient to cover its off-label use.

A similar ruling, delivered recently by a UK court in September 2018, also upheld the ability of health systems to use bevacizumab to treat eye disorders. The UK court ruled against Bayer and Novartis,andin favor of the National Health Service, saying that the service’s policy of offering bevacizumab as a preferred treatment option, due to its favorable cost-effectiveness, did not violate the law. According to the ruling, despite the fact that bevacizumab holds no marketing authorization to treat AMD, the National Institute for Health and Care Excellence had deemed the biologic appropriate for use.

Throughout Europe, there is a renewed push to utilize cost-saving bevacizumab to treat AMD; a paper published in PLOS One earlier this year argued that European nations are overspending on AMD therapy; Europe as a whole, said the paper’s authors, could save €335 million (approximately $386 million) yearly by treating 80% of people with AMD with bevacizumab rather than with competing anti-VEGF drugs.

Currently, no bevacizumab biosimilar is marketed in the European Union, though Mvasi, a biosimilar developed by Amgen, was authorized by the European Commission in January of this year.