UK court imposes safety rules on off-label use of Avastin in wet-AMD

Bayer has said a new UK court ruling could limit off-label use of Roche's Avastin in ophthalmology by imposing stricter safety and consent measures.

The UK’s Court of Appeal has upheld a lower court’s ruling that the cancer drug Avastin (bevacizumab) can be used off-label to treat the eye disease wet age-related macular degeneration (wet AMD) to save costs to the NHS.

Although there are licensed alternatives such as Bayer’s Eylea and Novartis’ Lucentis and Beovu, Roche’s cancer drug Avastin (bevacizumab) can be compounded and used to treat wet AMD, which is caused when rogue blood vessels grow in the centre of the retina (macula), causing blurred or reduced central vision.

NICE has also said that although bevacizumab is not licensed in wet AMD, it could be considered as cost-effective.

Avastin works by preventing growth of these blood vessels, and can be used at a lower dose, and can be diluted to save NHS money compared with licensed alternatives.

Novartis, Roche and Bayer have been challenging the policy first implemented by 12 clinical commissioning groups (CCGs) in England.

Following an appeal of a judicial review, the Court of Appeal has upheld the judgement of the Administrative Court that a policy preferring compounded bevacizumab is lawful.

The Court of Appeal has however confirmed that lawful implementation requires that individual patient prescriptions are in place prior to preparation and supply of compounded bevacizumab and that the compounding processes are conducted in accordance with appropriate standards.

Responding to the latest ruling, Bayer said the decision protects the interests of patients by ensuring the preparation and use of compounded bevacizumab must be considered on an individual patient basis, and by emphasising that compounding must be subject to appropriate quality control measures.

Bayer said: “Even if hospitals establish appropriate systems for lawful supply of compounded bevacizumab, patients must still be given enough time and information to make a fully informed decision about whether to agree to receive treatment which has not undergone regulatory assessment for use in wet AMD or in the eye at all, rather than a licensed treatment.”

The company pointed out that eye care services will need more staff and resources, and processes to administer the consent process, Bayer said.

Bayer nevertheless said it is considering an appeal to the Supreme Court.