NICE has approved rimegepant as the first treatment for acute migraine, in draft guidance published today.
Around 13,000 could benefit from rimegepant (Vydura, Pfizer), said NICE after signing off its use in adults who have tried at least two triptans but they did not work well enough.
It can also be used for those in whom triptans were contraindicated or not tolerated and NSAIDs or paracetamol had also been tried but with no success.
The committee considered trial evidence which showed that rimegepant – a wafer that dissolves under the tongue and is taken at the onset of a migraine attack – is more likely to reduce pain at two hours than placebo.
It prevents the release of calcitonin gene-related peptide (CGRP) thought to be responsible for the severe pain associated with migraine attacks.
The decision will mean an extra option for people who have found current treatments to be ineffective for their migraine attacks. For this group, guidelines recommend specialist referral but there are a limited number of headache centres and long waiting lists, the committee noted.
NICE put the cost of the drug at £12.90 per tablet and said the cost effectiveness analysis found it to below the threshold for a good use of NHS resources.
Earlier this year the novel drug was approved for episodic migraine where three previous treatments had failed.
But NICE had initially rejected rimegepant as not being an acceptable use of NHS resources for acute migraine but noted that because of a large unmet need, more evidence is needed to see if it could be cost effective.
It reassessed after further submissions from Pfizer and responses – including from patients and carers – to the consultation.
The Migraine Trust had commented that a 2023 workplace survey found that 43% of people suffering from migraines were affected financially and 74% were affected mentally.
A patient expert had told the committee that migraine has a large emotional and psychological burden on the day- to-day lives of those affected.
Migraines affect one in seven people in the UK and are two to three times more common in women, Pfizer said.
The final recommendation on rimegepant is expected in October.
Helen Knight, director of medicines evaluation at NICE, said: ‘This is the first and only NICE-recommended medicine that can help alleviate the misery of acute migraines, and may be considered a step-change in treatment.
‘Migraine is a condition described in comments to NICE from carers and people with migraine as an invisible disability that affects all aspects of life including work, education, finances, mental health, social activities, and family.
‘Today’s final draft guidance addresses the high unmet need for treatment options for acute migraine, once again demonstrating our ability to ensure clinically and cost-effective medicines are available to those who need them as quickly as possible.’
Professor Peter Goadsby, professor of neurology, King’s College London said: ‘Migraine can have a debilitating impact on those living with it.
‘Today’s decision, to offer a treatment which can be used at the onset of a migraine is a welcome step to help expand the options available to eligible patients.’