Erenumab, also known as Aimovig, was approved for use in Europe last year. But the body that approves new drugs, the National Institute for Health and Care Excellence (NICE), said there were doubts whether it was good enough or worth the money. NICE first rejected erenumab in draft guidance in January, but has now confirmed its decision in a final document. Erenumab works by blocking the calcitonin gene-related peptide receptor (CGRP-R), which is thought to play a critical role in migraine.
NICE has said there is insufficient evidence erenumab works better than Botox
But NICE has said there is insufficient evidence that the drug works better than Botox, which is available on the NHS, and said it had concerns about the type of patients in clinical trials run by Novartis.
NICE looked at Erenumab for preventing chronic and episodic migraine in adults who have four migraines a month or more.
Current medications for preventing migraine include beta-blockers,
antidepressants and epilepsy drugs.
If chronic migraine does not respond to at least three preventive drug treatments, Botox is usually offered.
NICE said it was concerned that clinical trials of Erenumab excluded people for whom all previous treatments had no therapeutic benefit.
It said “this group were likely to represent the people most in need of treatment and were therefore the most clinically important subgroup”.
NICE also said it was unclear whether Erenumab works in the long-term and there was no direct evidence from Novartis comparing Erenumab with Botox.
The drugs body concluded there was “a high degree of uncertainty as to whether Erenumab is more clinically effective” than Botox.
The Scottish Medicines Consortium approved the drug for use in patients with chronic migraine when other treatments had failed.
Haseeb Ahmad, UK managing director of Novartis, said the firm was “very disappointed” by the move.
He added: “This decision is particularly disappointing given Nice has recognised the clinical effectiveness and tolerability of Aimovig in chronic migraine, and there remains an unmet need for effective and well-tolerated preventive migraine treatments in the UK.”
He said unlike Botox, the drug can be injected at home and does not require repeated clinic visits or multiple injections into the head and neck.
“Furthermore, treatment with Botox may not be appropriate for everyone that lives with the devastating impact of chronic migraine,” he said.
Gus Baldwin, chief executive of The Migraine Trust, said: “This still feels like a very bad day for chronic migraine patients.”
Migraine is a common health condition, affecting around one in every five women and around one in every 15 men.
As well as having a moderate or severe headache, meany people also have symptoms such as feeling sick, being sick, increased sensitivity to light or sound.
Hannah Braye, nutritional therapist at Bio-Kult offered Express.co.uk some helpful tips to lessen the negative impact of a migraine.
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