Novartis and Bayer Warn on NHS Eye Drug Plan

European pharmaceutical industry heavyweights Novartis and Bayer are challenging a proposal by parts of the UK’s National Health Service (NHS) to allow patients with wet age-related macular degeneration (wAMD) to be treated with bevacizumab, the generic name for Roche’s off-patent colon cancer drug Avastin.

For most conditions, bevacizumab/Avastin is estimated to be ten times cheaper than the two patented drugs Lucentis, (ranibizumab), marketed by Novartis, and Eylea (VEGF Trap-Eye) from Bayer and Regeneron. Not only is the cancer drug now off-patent;  a vial can be split into multiple small doses suitable for injection into the eye.

Avastin is already used for wAMD treatment in parts of the US and Europe. In 2014, French lawmakers voted to allow this, despite the fact that Genentech, original developer of the drug, has opted instead to license a fragment of the active ingredient Novartis exclusively, to make Lucentis.

Commenting on that deal at the time, the biotech group said Lucentis, now the market leader, has been designed specifically for eye treatment, while Avastin has not.

The NHS, however, points to studies showing that bevacizumab is as safe and effective as Lucentis, based on by a US government-sponsored study published in 2011 and confirmed by a NHS-sponsored research a year later

 The health authority’s 12 northeast England clinical commission groups (CCCGs) filing the proposal to substitute Avastin said that using an equally effective generic would be preferable to cost-cutting measures such as rationing fertility treatment or cataract operations. They calculate that using the generic could potentially save more than £84 million a year.

In the UK, physicians are entitled to use any drug they believe their patients need, but the General Medical Council, which regulates the profession, stipulates that they should choose a licensed over an unlicensed medicine.

Without approval by the National Institute for Clinical Excellence (NICE), which would require a relevant license, Avastin cannot be made universally available through the NHS.  Novartis and Bayer have warned the health commissioners that they will seek a judicial review if the NHS decides to offer Avastin unlicensed.