NICE has published final draft guidance which recommends fremanezumab (Ajovy, Teva Pharmaceuticals) for preventing chronic migraine meaning around 10,000 people could benefit from the new migraine drug.
The draft guidance recommends fremanezumab for preventing chronic migraine in adults where at least three previous preventive treatments have failed, opening the way for up to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 (usually comprising acute treatments for migraine symptoms) for preventing chronic or episodic migraine in people who have already tried three preventive treatments. However, it is unclear if fremanezumab works better than Botulinum toxin type A, which is also recommended by NICE for preventing chronic migraine in these people.
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.
The company also offered an improved discount to the price of fremanezumab which means that it can now be considered a cost-effective use of NHS resources.
Fremanezumab 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.
Fremanezumab costs around £5000 per year at its list price, although a confidential commercial arrangement has been agreed with the company which makes it available at a discounted price.
Meindert Boysen, Director of the Centre for Health Technology Evaluation at NICE, said: “Chronic migraines are extremely debilitating a
nd 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 We are pleased that the company has been able to work with us to address the concerns highlighted in the previous draft guidance so that we are now able to recommend fremanezumab as an option for people with chronic migraine when several other medications have failed.”
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). A minority of these will be eligible for treatment with fremanezumab.
The aim of treatment is to reduce the frequency, severity or duration of migraine and improve quality of life. Current treatment options 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 explained that these treatments can have significant side-effects and can be ineffective for some people.
The draft guidance says that treatment with fremanezumab should be stopped if migraine frequency does not 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.