The draft guidance recommends fremanezumab for preventing chronic migraine in adults where at least 3 previous preventive treatments have failed, opening the way for up to 10,000 people to receive it on the NHS in England.
The clinical trial evidence shows that fremanezumab works better than best supportive care (which usually consists of acute treatments for migraine symptoms) for preventing chronic migraine in people who have already tried 3 preventive treatments.
The recommendation also includes people with chronic migraine for whom botulinum toxin type A has failed. New evidence submitted from the company shows that fremanezumab may be beneficial in these people.
Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: “Chronic migraines are extremely debilitating and can significantly affect a person’s quality of life. We are pleased that the company has been able to work with us to address the concerns highlighted in the previous draft guidance so that we are now able to recommend fremanezumab as an option for people with chronic migraine when several other medications have failed.”
Fremanezumab costs around £5000 per year at its list price but the company has offered a discount to the price which means that it can be considered a cost-effective use of NHS resources.
It works by targeting the process by which proteins cause blood vessels in the brain to swell, leading to the symptoms associated with migraines. It is given as a monthly self-administered injection.
It is estimated that there are 190,000 migraine attacks experienced every day in England with women more likely to experience one than men (5-25% versus 2-10% respectively).
The aim of treatment is to reduce the frequency, severity or the length of time a migraine lasts and improve quality of life. Current treatments for preventing migraine include botulinum toxin type A and drugs that are used for treating other conditions, such as beta-blockers, antidepressants and epilepsy medications. The patient experts who gave evidence to the NICE appraisal committee explained that these treatments can have significant side-effects and don’t work for some people.
The draft guidance says that treatment with fremanezumab should be stopped if migraine frequency doesn’t reduce by at least 30% after 12 weeks of treatment.
Registered consultees, including the company and patient and professional groups, now have the opportunity to appeal against the draft guidance. If no appeals are received final guidance is expected to be published in April 2020.