NICE has published final draft guidance which recommends galcanezumab (Emgality) for preventing migraine in adults if:
they have ≥4 migraine days a month
≥3 preventive drug treatments have failed
Treatment with galcanezumab after 12 weeks of treatment if:
in episodic migraine (
in chronic migraine (≥15 headache days/month) the frequency does not reduce by ≥30%.
Galcanezumab now joins fremanezumab, which NICE recommended as an option earlier this year for people with at least 15 migraine days each month at the same point in the treatment pathway.
Clinical trial evidence shows that galcanezumab works better than best supportive care for preventing chronic or episodic migraine in people who have already tried three preventive treatments.
The company presented clinical-effectiveness results for the subgroup of people for whom 3 or 4 preventive migraine therapies failed to produce clinically meaningful improvement from CONQUER, REGAIN, EVOLVE-1 and EVOLVE-2 trials. The results showed:
galcanezumab reduced the number of monthly headache days more than placebo for episodic and chronic migraine.
more people having galcanezumab had a reduction of ≥50% in the average monthly number of migraine days compared with placebo for episodic migraine.
more people having galcanezumab had a reduction of ≥30% in the average monthly number of migraine days compared with placebo for chronic migraine.
galcanezumab may work better than botulinum toxin type A.
The draft guidance on galcanezumab is now open for appeal. If no appeals are received, final guidance is expected to be published next month.