Bad news for 500,000 migraine sufferers in the UK as first new drug for 20 years is set to be rejected for use on the NHS – despite proof it prevents nearly half of attacks
- A monthly injection called erenumab prevents nearly half of migraine attacks
- The treatment has been developed by scientists over the last three decades
- And it has been available privately since September at the cost of £386 a month
- Patients say it is life-changing – halting the debilitating headaches and nausea
- But a draft decision by drugs watchdog recommends it be rejected for NHS use
The first new migraine drug for 20 years is set to be rejected for use on the NHS, in a blow to more than 500,000 people.
A monthly injection called erenumab prevents nearly half of migraine attacks for people who have few other treatment options, major trials have shown.
The treatment, developed by NHS-funded UK scientists over the last three decades, has been available privately since September at the cost of £386 a month.
Patients say it is life-changing – halting the debilitating headaches and nausea which can blight people’s lives.
But a draft decision issued by drugs watchdog NICE today recommends that it be rejected for use on the NHS.
Last July the drug – sold under the brand name Aimovig – was given a European medical licence patients who suffer migraines on at least four days a month and who have previously tried three types of oral treatment
Experts said the news was ‘devastating’ for patients.
NICE officials admitted erenumab is a ‘promising’ treatment which has been shown to be ‘clinically effective’.
But they said the company behind the drug – pharmaceutical giant Novartis – has not provided evidence that it is any better than Botox, which is commonly used by desperate migraine sufferers.
Because of this gap in the evidence officials believe the high price of the drug – nearly £5,000 a year minus a confidential discount offered to the NHS – means it cannot be shown to be cost-effective.
Novartis pointed out that Botox – which is designed as a cosmetic procedure but has been shown to help migraine sufferers – requires up to 40 injections into the head and neck by a trained specialist in a clinic.
Erenumab, in comparison, is self-administered into the thigh or belly with an injection pen.
More than eight million Britons – three quarters of them women – suffer migraine attacks, which involve dizziness, nausea and headaches. Figures estimate 38million are affected in the US.
Attacks can last anything from four to 72 hours.
More than eight million Britons suffer migraine attacks, which involve dizziness, nausea and headaches. Figures estimate 38million are affected in the US
The problem affects more people than diabetes, asthma and epilepsy combined – and is the sixth most common cause of disability in the world.
WHAT IS ERENUMAB?
Erenumab is the first in a new class of drugs which tackles the protein responsible for the pain and nausea associated with a migraine.
The protein – called calcitonin gene-related peptide (CGRP) – causes blood vessels intertwined with nerve endings in the head to swell up.
Erenumab blocks that process.
Described as one of the few true ‘holy grails’ of medical research, an injection to truly tackle migraines is being pursued by some of the world’s biggest drugs firms.
Erenumab is the first new migraine treatment since Triptans – drugs which ease the symptoms of migraines but not the cause – were developed in 1997.
It was developed over the last 30 years by Professor Peter Goadsby of King’s College London, who gave away the intellectual property to the drug when he published his first studies on CGRP in the 1990s.
Erenumab is made by a partnership between drugs giant Novartis and Amgen, but hot on their heels are three other firms – Teva, Eli Lilly and Alder – who are developing very similar drugs in a bid get a share of a global market worth an estimated £6.5billion a year.
Yet until now there has been no treatment specifically designed to prevent the problem, with patients instead given beta blockers, antidepressants and botox in a bid to stave off the crippling attacks.
Last July the drug – sold under the brand name Aimovig – was given a European medical licence patients who suffer migraines on at least four days a month and who have previously tried three types of oral treatment.
If it is approved by NICE that would mean about 500,000 people in Britain would be expected to benefit, although this could rise if the thresholds are lowered in the future.
Wendy Thomas, chief executive of the Migraine Trust, said: ‘This is extremely disappointing, and devastating for people whose lives are blighted by migraine.
‘It is terrible that people with migraine have had to wait so long for their own treatment, the first medication dedicated to treating migraine.
‘Now, after proving effective to many, it is not accessible to those who can’t afford to purchase it privately.’ Dr David Bloomfield, chief executive of the National Migraine Centre in London: ‘We know that many sufferers are waiting anxiously for Aimovig to be made available on the NHS.
‘We are therefore disappointed at the outcome of the draft guidance – we hope that NICE and Novartis are able to resolve the current impasse and clinicians are provided with another treatment option.’
NICE said it would work with Novartis to ‘ensure that they are given every opportunity’ to address officials’ concerns before a final decision is issued later this year.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: ‘Erenumab is a promising new preventive treatment for migraine that has been shown to be clinically effective compared with best supportive care.
‘However, there was not enough evidence to suggest that it is more effective than botulinum toxin type A [botox] for people with chronic migraine, which NICE already recommends.’
Haseeb Ahmad, country president of Novartis UK, said: ‘If this decision remains unchanged patients will be denied access to the first licensed treatment specifically designed to prevent migraine in adults.
‘NICE does not consider the impact of diseases on broader society when evaluating the cost-effectiveness of medicines.
‘We believe this fails to capture the true value of medicines like Aimovig. As migraine predominantly affects people of working age, it costs the UK economy £8.8billion per year in lost productivity alone.’