National Institute for Health and Care Excellence (NICE) is set to approve a new prophylaxis treatment for migraine. Draft guidance published today (12 March 2020) recommends fremanezumab (Ajovy) as an option for preventing migraine in adults if:
- the migraine is chronic (≥15 headache days a month for more than three months with more than eight of those having features of migraine).
- more than three preventive drug treatments have failed.
Fremanezumab treatment should be stopped if the migraine frequency does not reduce by ≥30 per cent after 12 weeks of treatment.
Clinical evidence was drawn from the double-blind randomised controlled FOCUS trial for the subgroup of people for whom two to four preventive migraine therapies failed to produce clinically meaningful improvement, were intolerable or were contraindicated or unsuitable. Between baseline and week 12, fremanezumab reduced the number of monthly migraine days more than placebo for episodic and chronic migraine. More people on fremanezumab had a reduction of ≥50 per cent in the average monthly number of migraine days compared with placebo for episodic migraine.
More people on fremanezumab had a reduction of ≥30 per cent in the average monthly number of migraine days compared with placebo for chronic migraine, and it also reduced the monthly number of days where acute headache medication was used for both episodic and chronic migraine.
It is unclear if fremanezumab works better than botulinum toxin type A. However, new evidence submitted by the company suggests the treatment may be beneficial in people with chronic migraine for whom botulinum toxin type A has failed.
At its list price, fremanezumab costs around £5000 per year, but a confidential commercial arrangement between the NHS and the company will make the treatment available to the NHS at a discounted price.
The draft guidance is now open to public comment. The final decision is expected to be published in April.