High Court rules bevacizumab can be prescribed for wet AMD

Companies Novartis and Bayer have lost their legal case to prevent the off-label use of Roche’s anti-angiogenic therapy bevacizumab (Avastin) to treat wet age-related macular degeneration (AMD).

Like Novartis’ and Bayer’s own licensed treatments – ranibizumab (Lucentis) and aflibercept (Eylea) – bevacizumab is an anti-vascular endothelial growth factor (VEGF) therapy. Bevacizumab is marketed for the treatment of various forms of cancer; however, it does not have a licence for wet AMD. It costs just £28 per treatment, compared with over £500 and £800 for ranibizumab and aflibercept respectively.

Novartis and Bayer originally brought the case against 12 CCGs in the north of England, who were offering patients with wet AMD the option of treatment with bevacizumab. The companies argued that such use of the medicine was unlawful because it is not licensed for use in the eye and it undermined drug regulation and patients’ right to a NICE-approved drug. However, the High Court ruled that bevacizumab could be lawfully prescribed for this indication on cost grounds.

Bayer has now said it intends to challenge the decision in the Court of Appeal, adding that the ruling is “a setback for public health” and that it “has the potential to set a worrying precedent that denies patients the protection afforded by the regulatory process”.

The NICE guideline on AMD, published in January (NG82), does not specifically recommend the use of bevacizumab because of its unlicensed status; however, a footnote to the guidance adds: “Given the guideline committee’s view that there is equivalent clinical effectiveness and safety of different anti-VEGF agents (aflibercept, bevacizumab and ranibizumab), comparable regimens will be more cost effective if the agent has lower net acquisition, administration and monitoring costs.”

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