Roche Fights Off Challenge To Off-Label Use Of Avastin For Treatment Of Wet AMD

Enable Law Legal Director Laurence Vick analyses the landmark Bayer/Novartis v NHS Darlington CCG 21 September 2018 Judicial Review Decision

In a landmark ruling, a group of 12 clinical commissioning groups (CCGs) successfully defeated a judicial review brought by the pharmaceutical companies Novartis and Bayer seeking to prevent NHS doctors offering patients a choice between their 2 licensed medicines Lucentis (ranibizumab) and Eylea (aflibercept) and Roche’s significantly cheaper alternative Avastin (bevacizumab) for the serious eye condition wet age-related macular degeneration (wet AMD). The policy adopted by the CCGs stated that Avastin will be offered to certain patients with wet AMD “as the preferred treatment option.”

Age-related macular degeneration affects over 600,000 people in the UK, with 40,000 of those suffering from wet AMD. Wet AMD develops when abnormal blood vessels form and damage the cells at the back of the eye. Timely diagnosis and treatment is crucial; drugs are injected into the eye to stop the growth of the abnormal blood vessels. Left untreated the condition results in visual impairment or blindness within three years.

Lucentis is licensed for the treatment of wet AMD, whereas Avastin – although recommended by the WHO for treating eye conditions and used widely by doctors in the UK private sector as well as across Europe and in the US where most prescribing decisions are dictated taken by health insurers – is only licensed in the UK for the treatment of certain cancers.

The CCGs had argued that prescribing Avastin ‘off-label’ for wet AMD saved the NHS ‘hundreds of millions’ a year: the cost to the NHS of Avastin is about £28 per injection compared with £551per injection of Lucentis and £816 for Eylea. The NHS annual spend on Lucentis is £244m, the second highest amount for any drug. The NHS justified its policy on the basis that studies had shown Avastin to be as safe and to have the same level of clinical effectiveness as the 2 more expensive drugs.
NHS doctors concerned as to their legal position when prescribing a drug ‘off-license’ which would save the NHS money and was regarded as safe and effective sought clarification from the GMC.

In January 2018 NICE issued guidelines on the treatment of AMD and the GMC also clarified its approach to clinicians who prescribed Avastin for ophthalmic use. Following submissions from the Royal College of Ophthalmologists the GMC issued a statement reassuring 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.”

The Claimants Bayer and Novartis challenged the lawfulness of the CCGs’ policy on four grounds: that the supply of Avastin was unlawful because it was not licensed for ophthalmic use; it undermined European drug regulation; it undermined patients’ right to access drugs recommended by NICE; and the patient information and Q & A sheets accompanying the policy were misleading and inaccurate.

The High Court had to consider a wide range of issues and arguments.

The Judge found that there is an established, mature market in Avastin in the UK and Europe for ophthalmic use.

The Claimants argued that the European Court effectively ruled out blanket policies allowing off-label prescribing of medicines on grounds of cost, which was also reflected in the medicines and healthcare products regulator (MHRA) guidelines stipulating that cost, convenience or operational needs cannot be factors driving prescribing decisions. The Claimants challenged the competency of NICE and the NHS to make decisions over whether their drugs were safe, clinically effective or cost-effective and argued that clinicians are not permitted when prescribing to take account of the cost of a drug.

Mrs Justice Whipple dismissed the judicial review application on all grounds and found in favour of the CCG’s.

The ways in which the CCGs had implemented the NHS policy were entirely lawful. Clinicians have a professional duty to make the most appropriate use of NHS resources. The Judge rejected the Claimants’ contention that Avastin was not as safe for ophthalmic treatment as their own licensed alternatives. It was unnecessary for the Court to consider the safety issues and the expert evidence produced by the Claimants because CCGs and NICE were legally competent to make their own decisions as to whether drugs were safe and clinically effective. The Judge placed significant weight on the fact that NICE had published a 500 page report after the CCGs had adopted the NHS policy which concluded that “Avastin is as safe as the licensed alternatives”.

The Judge rejected the Claimants’ argument that the CCGs’ policy undermined NICE’s guidance which in fact requires NHS patients to be given options.

REACTION
The decision is likely to have far-reaching implications for the NHS.
The option for the NHS of permitting the use of ‘off-label’ drugs at lower cost has now been clarified. NHS Confederation chief executive Niall Dickson 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. Within evidence-based guidelines, clinicians need to be able to use their professional judgment to make the best decisions for their patients”

The RNIB’s Helen Lee welcomed the ruling “It is critical each patient has the opportunity to have a full discussion with their clinician to give consent prior to switching or embarking on treatment all savings generated by providing Avastin rather than licensed anti-VEGF drugs must be invested in eye care services.”

Novartis said they were “disappointed” because patients were being asked to accept an unlicensed treatment to save the NHS money.” the policy undermines the well-established legal and regulatory framework that is there to protect both patients’ safety and to ensure health care professionals can prescribe with confidence.”

Clinicians confused over what they can and can’t prescribe now have clarification of their legal and professional responsibilities and will be reassured that they will not face criticism s or the possibility of a referral to the GMC if they prescribe ‘off-label’ Avastin instead of Lucentis or Eylea.

The applicants Bayer and Novartis have until 12 0ctober 2018 to apply for permission to appeal.