1.1 Fremanezumab is recommended as an option for preventing migraine in adults, only if:
the migraine is chronic, that is, 15 or more headache days a month for more than 3 months with at least 8 of those having features of migraine
at least 3 preventive drug treatments have failed and
the company provides it according to the commercial arrangement.
1.2 Stop fremanezumab if the migraine frequency does not reduce by at least 30% after 12 weeks of treatment.
1.3 This recommendation is not intended to affect treatment with fremanezumab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Treatment options for preventing chronic or episodic (less than 15 headache days a month) migraine include beta-blockers, antidepressants and anticonvulsant drugs. If chronic migraine does not respond to at least 3 preventive drug treatments, botulinum toxin type A or best supportive care (treatment for the migraine symptoms) is offered. If episodic migraine does not respond to at least 3 preventive drug treatments, best supportive care is offered.
For people whose migraine has not responded to at least 3 oral preventive treatments, clinical trial evidence shows that fremanezumab works better than best supportive care in both episodic and chronic migraine. However, it is unclear if fremanezumab works better than botulinum toxin type A.
For chronic migraine, assuming fremanezumab works better than botulinum toxin type A, the most likely cost-effectiveness estimates are within the range NICE normally considers an acceptable use of NHS resources. So it is recommended for chronic migraine. In line with clinical practice, fremanezumab treatment should stop if it is not working well enough after 12 weeks.
For episodic migraine, uncertainty in the economic modelling about stopping treatment and quality of life affects the cost-effectiveness estimates. The most likely estimates for fremanezumab are higher than what NICE normally considers an acceptable use of NHS resources. So it is not recommended for episodic migraine.