A MIGRAINE drug described as "life changing" by some patients has been approved for use by the NHS in Scotland.
Thousands of patients are set to benefit after the Scottish Medicines Consortium (SMC) accepted fremanezumab having taken into account the benefits of a "confidential discount" that it said improved the cost-effectiveness of the drug produced by Teva Pharmaceuticals.
Fremanezumab, which is being marketed as Ajovy, is one of a new class of drugs which works by targeting a small protein found in nerve cells called calcitonin gene-related peptide (CGRP), which is believed to be involved in causing the pain in migraine attacks.
READ MORE: Migraines are part of me - would I stop them?
It is part of a migraine treatment revolution which benefits sufferers who have historically had, until recently, few treatment options for what can be a debilitating chronic disease.
The SMC has also approved the use of abiraterone acetate (Zytiga) for use by NHS Scotland to help extend the lives of those with advanced prostate cancer. In Scotland, some 3500 men are diagnosed each year with the cancer.
The treatment can extend survival times for the incurable disease, compared to using hormone therapy alone. SMC chairman Dr Alan MacDonald said: “From the evidence provided to us by patient groups, we know that our decision on fremanezumab will be welcomed by those suffering from migraine who have not responded to previous treatments.”
The move to approve fremanezuma has been welcomed by The Migraine Trust which said that Scotland has become the only nation in the UK where 'CGRP inhibitors' have been approved to treat the condition on the NHS.
The Trust said fremanezumab, is the first dedicated migraine preventive medication that will be available to treat both chronic and episodic migraine, "thereby expanding its availability to many more people living with migraine".
The Trust submitted new evidence about the effectiveness and impact of 'CGRP inhibitors' during the SMC appraisal process for fremanezumab.
Teva produced a video to help sufferers understand what causes migraines and how the fremanezumab treatment works.
The new evidence included the findings from our recent survey of over 200 chronic migraine patients who have recently been treated with a CGRP drug.
READ MORE: Botox to be prescribed on NHS in Scotland for migraine patients
The survey found that using a CGRP drug improved the lives of 80% of respondents, with many saying that it was ‘life changing’ for them.
Gus Baldwin, Trust chief executive said: "This is wonderful news for the many people in Scotland living with migraine.
"Not only is it an extremely painful and debilitating brain disease, but it also significantly impacts many aspects of the lives of those who get migraine.
"Our research has found that this easy to use treatment prevents migraine attacks for many and significantly improves their quality of life.
"This does mean that the national disparity in migraine treatment options increases though. It doesn’t seem fair that access to life-changing migraine medication within the UK depends on your postcode, and I hope that this situation is rectified in the near future.”
Teva said that it could help some of the estimated 740,000 Scottish migraine patients - those with chronic and episodic migraine who have had prior failure on three or more preventative treatments.
SMC documents say there would be 13,886 episodic migraine patients eligible for the £5,400-per-patient-per-year treatment annually, with a further 6,527 chronic migraine patients.
Chronic migraine is defined as more than 15 headache days per month of which more than eight involve migraine symptoms. Episodic migraine sufferers have 0 to 14 headache days per month.
According to the 2016 Scottish Burden of Disease Study, migraine is the seventh most common cause of disease burden in Scotland, and across all age groups women experienced a greater proportion of the migraine burden than men.
According to the Migraine Trust, it is the third most common condition in the world, and has a significant financial burden on the UK economy, "conservatively estimated" at £3.42 billion per year.
I am delighted that SMC have approved fremanezumab for use in Scotland,” said Dr David Watson, a GP specialising in headaches who also works in the neurology department at Aberdeen Royal Infirmary. “The clinical trials show that it can reduce migraine frequency and severity and make a significant impact in patients with migraine disability. As a practising clinician it is very helpful to have more options to treat patients with migraine.”
In April, the SMC approved another drug erenumab (Aimovig) produced by Novartis for chronic sufferers only, but was rejected for use in the rest of the UK. The National Institute for Health and Care Excellence (NICE) confirmed a decision to reject the £5,000-per-patient-per-year drug for England and Wales on the grounds that it was not cost-effective.
Migraine is a neurological disorder characterised by disabling attacks of moderate to severe throbbing headache, which can be associated with nausea and vomiting and sensitivity to light, sound and smell. It is often severe enough to exact a heavy toll on someone’s ability to work, interact with others and perform the tasks of daily life.
A recent survey by the Japanese Headache Society of more than 2,400 workers at the Tokyo-based IT company Fujitsu found the productivity of one employee in five was impaired by migraine, at an estimated cost to the company of nearly 150,000 employees of £270m a year.
To treat an attack of migraine, doctors have long relied on drugs called triptans that act like the nervous system chemical serotonin to target the nerves that transmit pain signals.
“Teva is very pleased with the SMC decision, as we seek to expand the availability of fremanezumab across the UK in an effort to ensure that patients living with migraine have access to this treatment option,” said Kim Innes, Teva's UK and Ireland general manager.
"I believe that the introduction of fremanezumab in Scotland, having been accepted by the SMC for prevention of both chronic and episodic migraine, and with its flexible dosing options, will bring new opportunities and enable better days for those struggling to control this disabling condition.”
The SMC also approved the use of two other drugs for routine use on Scotland’s NHS - ocrelizumab (Ocrevus) for early primary progressive multiple sclerosis and Brentuximab vedotin (Adcetris) for a white blood cell cancer.
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