NICE Draft Guidance Approves Fremanezumab for Chronic Migraine

Dawn O'Shea

March 16, 2020

The National Institute for Health and Care Excellence (NICE) is set to approve a new prophylaxis treatment for migraine. Draft guidance published on 12th March 2020 recommends fremanezumab (Ajovy, Teva UK) as an option for preventing migraine in adults if: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% 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% in the average monthly number of migraine days compared with placebo for episodic migraine.

More people on fremanezumab had a reduction of ≥30% 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.

In a news release, Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "We are pleased that the company has been able to work with us to address the concerns highlighted in the previous draft guidance so that we are now able to recommend fremanezumab as an option for people with chronic migraine when several other medications have failed."

The draft guidance is now open for public comment. The final decision is expected to be published in April.

Adapted from Univadis from Medscape.

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