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    Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Fremanezumab is not recommended, within its marketing authorisation, for preventing migraine in adults who have at least 4 migraine days per month.

1.2 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 (15 headache days a month or more) or episodic (less than 15 headache days a month) migraine include beta-blockers, antidepressants and epilepsy medications. 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. But there is only indirect evidence comparing fremanezumab with botulinum toxin type A in chronic migraine. This shows that it is very uncertain whether fremanezumab is more clinically effective than botulinum toxin type A.

The cost-effectiveness results are highly sensitive to assumptions about treatment effectiveness after stopping treatment, which are not supported by evidence and are highly uncertain. The most likely estimates of cost effectiveness for fremanezumab for both episodic and chronic migraine are higher than what NICE normally considers an acceptable use of NHS resources. Therefore, fremanezumab is not recommended.