High Court rejects Novartis, Bayer’s bid to outlaw off-label Avastin

Roche/Genetech’s anti-VEGF therapy Avastin (bevacizumab) is not licensed to treatment wet-AMD, but trials have shown that it is as safe and effective (IVAN trial), and much cheaper than approved Lucentis (ranibizumab) or Eylea (aflibercept), also both anti-VEGF treatments.

Lucentis costs £551 per injection, Eylea £816 per injection, but Avastin’s price is much lower at just £28 per shot for use in wet AMD; an article published by the Guardian last November argued that using the latter off-label to treat wet-AMD could save the NHS more than £84 million a year.

The judicial review requested by Bayer and Novartis was in response to a policy proposed by 12 Clinical Commissioning Groups in the North of England to prefer use of Avastin over Lucentis and Elyea.

The European Court has in effect ruled out blanket policies that allow off-label prescribing of medicines on the grounds of cost, which is also reflected in Medicines and Healthcare Products Regulatory Agency (MHRA) guidelines which stress that cost, convenience or operational needs cannot be factors driving the decision to do so.

However, earlier this year the General Medical Council issued a statement to reassure doctors that where they are "working in partnership with patients, following clinical guidance and making prescribing decisions in good faith on the basis of evidence and experience, the use of Avastin would not cause us any concerns".

Now, the High Court has decided that, in certain circumstances, it is potentially lawful to offer patients Avastin injections for the treatment of wet AMD in preference to approved licensed treatments.

Bayer argues 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."

Avastin is not manufactured or licensed for use in the eye, it stressed, adding that "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."

The firm also noted that doctors "may potentially be required to encourage patients to choose a treatment which is unlicensed for use in the eye, over approved regulatory licensed treatments for this indication that have been assessed as cost-effective use of NHS resources by the National Institute for Health and Care Excellence (NICE)."

But Niall Dickson, chief executive of the NHS Confederation, said: "This is great news for patients, taxpayers and the NHS. Having to pay far too much for one medicine when another much cheaper one is just as good, is a nonsense and the court has recognised that. Scarce NHS resources must be protected."

He went on to stress that "within evidenced based guidelines, clinicians need to be able to use their professional judgment to make the best decisions for their patients," and that the ruling "should save the health service up to hundreds of million pounds a year".

He also called on "NHS organisations across the UK need to act on this judgement and make sure the benefits are realised immediately."

Also in favour of the decision, RPS President Ash Soni said: "This is a landmark ruling and good news for patients and the NHS.

"Avastin has been shown through real world evidence to be a safe and effective for 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."

However, Dr Sheuli Porkess, deputy chief scientific officer at the ABPI, said the "extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust.

"As we exit the EU and the UK Government is looking for regulatory co-operation between the UK and the EU, this confusion is deeply unhelpful."

Bayer said it is now considering all options available, including an appeal of the decision.

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