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Medicines regulation and law

Legal ruling on off-label drug use could save NHS money

A ruling by the high court on the use of off-label drugs has been welcomed by the NHS, but faces opposition from pharmaceutical companies.

Close-up photograph of retina with macular degeneration


Treatment of wet age-related macular degeneration, a leading cause of vision loss, is set to become cheaper following a ruling by the High Court

A landmark ruling on treatment for wet age-related macular degeneration (wet AMD) that could save the NHS millions of pounds has been welcomed by healthcare leaders and clinicians.

The High Court ruled that, in certain circumstances, it is potentially lawful to offer patients Avastin (bevacizumab) injections as an alternative to licensed treatments Lucentis and Eylea, sold by Novartis and Bayer, respectively.

While Avastin is included on the World Health Organization’s essential medicines list for treating eye disease, in the UK the drug is only approved for the treatment of cancer.

Twelve clinical commissioning groups (CCGs) in the north of England had begun to use the alternative treatment before Novartis and Bayer took legal action against them.

The court’s decision was welcomed by healthcare leaders and clinicians, with Ash Soni, president of the Royal Pharmaceutical Society, saying the ruling was “good news for patients and the NHS”.

He said Avastin had been shown “through real world evidence to be a safe and effective treatment for age-related wet macular degeneration”.

“The additional bonus is that it saves the NHS a significant amount of money, which can then be used to help other patients,” added Soni.

He said that ‘off -label’ use “should not be feared if real world evidence, plus the efforts of pharmaceutical scientists, doctors and pharmacists working together have shown that the treatment is safe, effective and the best use of NHS resources”.

David Hambleton, CCG chief officer in South Tyneside — one of the 12 CCGs using the alternative treatment — said the drug would save “in excess of £13.5m per year for the 12 CCGs involved in this litigation alone”.

Novartis said it was “deeply disappointed” by the decision because patients were being asked to accept an unlicensed treatment to save the NHS money.

Bayer said it was now considering “all options available to us, including an appeal of the decision”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205492

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