Drug giants’ legal threat to the NHS for using cheaper jabs
TWO of the world’s biggest drugs firms are threatening to sue the NHS to stop it using a treatment nearly 70 times cheaper than their medication.
Novartis and Bayer made the threat against 12 health boards in Cumbria and North-East England which have advised doctors to use a different treatment for a devastating eye condition.
Doctors have accused the pharmaceutical giants of trying to ‘dictate’ which drugs they can use.
The NHS clinical commissioning groups want to use a drug called Avastin for patients with wet age-related macular degeneration, or wet AMD.
They calculate that at £12 per injection, Avastin would save them £13.5 million a year compared to the current drugs they use – Novartis’s Lucentis (£742 a dose) and Bayer’s Eylea (£816). They say the saving could pay for an extra 270 nurses in the region.
But Novartis and Bayer have threatened to launch a judicial review, saying the move breaches health rules.
Wet AMD, which affects about 70,000 elderly people in the UK, causes them to rapidly lose their central vision when blood vessels start growing across the retina at the back of the eye. The treatments, which are injected directly into the eye, stop the growths.
Avastin was initially designed as a breast cancer treatment, and so does not have a licence for use as eye medication. And because its patent expires in 2022, its maker Roche has nothing to gain from an expensive licence application. But studies have shown it is just as good as Lucentis or Eylea at stopping visual decline, and it is used ‘off-label’ around the world for elderly eye patients.
If the NHS switched entirely to Avastin, it would save an estimated £500million a year, but off-label use of drugs is permitted only if there is no medical alternative. Novartis and Bayer claim NHS patients have a legal right to be offered drugs that have been approved by drugs watchdog NICE.
David Hambleton, chief officer of South Tyneside clinical commissioning group, last night condemned the companies’ aggression.
Writing in the British Medical Journal, he said: ‘We have no interest in protracted legal disputes, but pharmaceutical companies should not dictate which drugs are available to NHS patients.
‘The choice between three clinically effective drugs should be one for NHS clinicians and patients to make together, not for drug companies.’
He said the 12 health boards had agreed a new policy which would offer patients the choice between the three drugs – but point out the cost of each.
‘We intend to share informa- tion with patients through accessible media – including leaflets and audiovisual material – about the treatment options available, the evidence base, and the comparative costs, and allow them to make their own choice.
‘Every patient who chooses the cheaper alternative drug will help the NHS to fund important medical treatment in other areas.’
Bayer, which said elderly patients with eyesight problems may lack the cognitive capacity to make a fully informed decision about their treatment, and Novartis last night confirmed they were considering legal action.
A spokesman for Bayer said: ‘The principle of using unlicensed medicines when licensed
‘They shouldn’t dictate to us’
and NICE-approved options are available runs the risk of setting a precedent that undermines the regulatory framework and NHS constitution. Bayer is currently considering its position including the possibility of legal proceedings.’
A Novartis spokesman accused the health boards of producing ‘misleading’ information. She added: ‘The framework provides that unlicensed medicines can only be used where there is an unmet medical need. That is not the case here as there are two licensed products available in the UK, both of which have been approved by NICE as clinically and cost-effective.’
Professor Andrew Lotery, an ophthalmologist at Southampton University, told the BMJ: ‘ It’s purely the regulatory framework that is stopping [Avastin’s] widespread use in the NHS.’ He said his eye unit was under ‘extreme pressure’ over costs, and using a cheaper treatment would increase funds for other frontline care.
Prescribing an off-label drug goes against guidance by the General Medical Council, but its assistant director of standards and ethics, Mary Agnew, hinted the organisation was looking carefully at the matter.
She said: ‘We hope that some sort of licensing solution for drugs such as Avastin may be forthcoming, or alternatively that the situation is clarified in the courts to give doctors more assurance about when they can prescribe this drug safely and within the law.’