Europe – High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin

Bayer and Novartis have lost a landmark case in the UK seeking to prevent the off-label use of Roche’s Avastin to treat wet AMD, a leading cause of sight loss in the elderly.

Roche/Genetech’s anti-VEGF therapy Avastin (bevacizumab) is not licensed to treatment wet-AMD, but trials have shown that it is as safe and effective (IVAN trial), and much cheaper than approved Lucentis (ranibizumab) or Eylea (aflibercept), also both anti-VEGF treatments.

Lucentis costs £551 per injection, Eylea £816 per injection, but Avastin’s price is much lower at just £28 per shot for use in wet AMD; an article published by the Guardian last November argued that using the latter off-label to treat wet-AMD could save the NHS more than £84 million a year.

The judicial review requested by Bayer and Novartis was in response to a policy proposed by 12 Clinical Commissioning Groups in the North of England to prefer use of Avastin over Lucentis and Elyea.

The European Court has in effect ruled out blanket policies that allow off-label prescribing of medicines on the grounds of cost, which is also reflected in Medicines and Healthcare Products Regulatory Agency (MHRA) guidelines which stress that cost, convenience or operational needs cannot be factors driving the decision to do so…