Novartis, Bayer consider appeal as court says Avastin can be used in AMD

England’s High Court has ruled it is lawful to use Roche’s Avastin (bevacizumab) in an unlicensed use in wet age-related macular degeneration (AMD) instead of more expensive approved drugs from Novartis and Bayer.

While NHS organisations welcomed the judgement on the grounds that it will save money, the drug companies said they are considering an appeal against the decision, arguing it undermines the EU’s regulatory system for medicines.

Avastin is licensed as a cancer drug, where it works by attacking the blood vessels that feed oxygen to tumours.

But this mechanism of action means it can also work in wet AMD, which is caused by abnormal growth of blood vessels in the back of the eye, causing blurring or loss of vision in the centre of the field of vision.

Novartis’ Lucentis (ranibizumab) and Bayer’s Eylea (aflibercept) are approved in wet AMD, but Avastin’s manufacturer Roche has never applied for a licence in ophthalmology.

But an independent trial by the US National Institutes of Health in 2012 found that Avastin was as effective as Lucentis in treating wet AMD, although serious adverse events were slightly more common with the Roche drug than with Lucentis.

The trial paved the way for off-label use of Avastin in wet AMD, at a much lower price as it is administered at around 1/500th of the dose used in oncology indications.

In England, 12 clinical commissioning groups had been using Avastin in wet AMD, and Novartis and Bayer called for a judicial review in a bid to make them use more expensive licensed alternatives.

Bayer and Novartis issued tersely-worded statements, saying they were considering an appeal against the decision, where the High Court ruled that Avastin could be used lawfully as part of a policy to save costs.

Describing the decision as a “setback for public health,” Bayer added that “the ruling prioritises the cost of medication over doctors’ clinical judgement and expertise, as well as over the regulatory assessment of a medicine’s quality, efficacy and safety.

“Bevacizumab, marketed as Avastin for the treatment of cancer, is not manufactured or licensed for use in the eye. A service using this product risks increasing the number of clinic visits and injections a patient needs for proper monitoring of their conditions and for sight-saving treatment, placing more strain on NHS services and the already stretched workload of NHS staff.”

Novartis made a similar argument in its statement, saying the ruling “threatens to jeopardise a world-leading system that has protected patients for many years by ensuring medicines have been tested rigorously and carefully scrutinised for delivering value.”

Dr Sheuli Porkess, deputy chief scientific advisor to the Association of the British Pharmaceutical Industry (ABPI), said: “We will consider this judgement carefully. Patients and doctors need total clarity on who determines whether medicines work and are safe to be used.

“This extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.”

David Hambleton, chief executive officer of NHS South Tyneside clinical commissioning group (CCG), one of the NHS groups involved in the case, welcomed the judgement.

He told the BBC: “We've always said we think that it's important that patients should have the choice of a very effective treatment for wet AMD, and it's actually a fraction of the cost of the other alternatives.

“So I think what we do now is offer patients that choice. We believe that they will support very strongly having a cost-effective, safe treatment and saving the NHS generally a lot of money. It is a victory for common sense over commercial interests.”

Photograph courtesy of Roche