An oral treatment for preventing episodic migraine in adults was the first to be approved for routine NHS use in England, the National Institute for Health and Care Excellence (NICE) said.
In final draft guidance on Wednesday, NICE recommended rimegepant (Vydura, Pfizer) as an option where at least three previous preventive treatments had failed.
Although the move was welcomed by The Migraine Trust, the charity said it was "concerned" that rimegepant had not been approved for acute use, warning that the decision could leave too many people at risk of medication overuse headache.
More than 5.6 million people in England are believed to experience episodic migraines, with an estimated 190,000 migraine attacks taking place every day. NICE said its approval for rimegepant – an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist – could be available for up to 145,000 patients.
Effective and Value for Money
An evaluation committee accepted clinical trial evidence showing that rimegepant – one of the class of gepant medications – reduced monthly migraine days more than placebo. Although the drug, which is administered as an orally disintegrating tablet, had not been directly compared in a trial with usual treatments erenumab, fremanezumab, or galcanezumab, indirect comparisons suggested that it was likely to be similar to or less effective than the other drugs. It also decided that rimegepant, at a proposed price of £12.90 per 75-mg tablet, was cost effective compared with two or three usual treatments.
As a result, NICE decided that rimegepant should be recommended as an option for preventing episodic migraine in adults who have at least four, and fewer than 15, migraine attacks per month, but only when at least three preventative treatments had not worked. Treatment with rimegepant should be stopped after 12 weeks if the frequency of migraine did not reduce by at least 50%, the regulator said.
Final guidance on rimegepant for preventing episodic migraines is expected next month. Commenting on the decision, Helen Knight, director of medicines evaluation at NICE, said rimegepant was "the first oral treatment for migraine to be recommended by NICE" and that it was "likely to be a welcome and more convenient addition to existing options for a condition that is often overlooked and undertreated".
Not Recommended for Acute Treatment
In draft guidance also published on Wednesday, NICE said it had decided not to recommend rimegepant for acute treatment of migraine with or without aura in adults, despite clinical trial evidence that the drug was more likely to reduce pain at 2 hours than placebo.
The evaluation committee considered that cost-effectiveness estimates for rimegepant for acute migraine exceeded what NICE considered to be an acceptable use of NHS resources. However, it promised further work would be carried out to see if rimegepant could be cost effective in patients who cannot be treated with triptans where it recognised there was an unmet treatment need.
The evaluation committee has scheduled a follow-up meeting to consider the evidence in August, after which final draft guidance is expected in October.
Migraine Charity 'Disappointed'
The Migraine Trust expressed disappointment at the decision not to recommend rimegepant for acute use, particularly as the Scottish Medicines Consortium accepted it for restricted use within NHS Scotland in April.
The trust's chief executive, Rob Music, said: "Too many people with migraine end up with medication overuse headache as a result of their migraine treatment, which has a serious impact on their lives. This is an impact which is preventable if migraine is treated effectively. Gepants, the new class of migraine medication which rimegepant is part of, can help prevent this happening."
The charity said it was pleased at the decision to approve the drug for preventative use in England.