Rimegepant (Vydura, Pfizer) has been recommended by the National Institute for Health and Care Excellence (NICE) as a cost-effective option for treating acute migraine in adults, forecasting that thousands of migraine patients in England would benefit as a result.
NICE had previously recommended the calcitonin gene-related peptide (CGRP) receptor agonist for preventing migraine in adults.
At the start of the migraine process, CGRP is released by nerves, which prolongs and sustains the migraine attack. Gepants bind to the CGRP receptor on the trigeminal nerve blocking this effect.
Rimegepant — one of a class of gepants — is the first dual-indication treatment approved for both acute and preventative treatment of migraine. The manufacturer commented that the drug was the "first targeted" acute migraine treatment.
"Compared to conventional acute treatments such as triptans, non-steroidal anti-inflammatory drugs (NSAIDs), and other painkillers, the gepants don't seem to cause rebound or medication overuse headache," highlighted the Migraine Trust.
Recognition of an Unmet Need
In May this year, NICE said that rimegepant was "not recommended", within its marketing authorisation, for acute treatment of migraine with or without aura in adults. However, it added that "because there is an unmet need for people who cannot have triptans, more evidence is needed to see if rimegepant could be cost effective in this group".
In coming to its latest decision to recommend rimegepant, NICE recognised the "substantial burden" that migraine had on quality of life and day-to-day functioning, and predicted that the drug would be available to around 13,000 people.
"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," alerted Helen Knight, director of medicines evaluation at NICE.
The regulator also pointed out that currently, when triptans were ineffective, not tolerated, or contraindicated, there was "no further standard treatment" and people were advised to see a migraine specialist. "But there are a limited number of headache centres in the UK and there are long waiting lists," it stressed.
"Today's final draft guidance addresses the high unmet need for treatment options for acute migraine," Ms Knight said.
A 'Step-Change' in Treatment
Rimegepant was recommended as an option for the acute treatment of migraine with or without aura in adults, only if for previous migraines at least two triptans had been tried but did not work well enough, or triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough.
Clinical trial evidence for acute migraine showed that rimegepant was more likely to reduce pain at 2 hours than placebo. The most likely cost-effectiveness estimates were below or within what NICE considered to be an acceptable use of NHS resources, the regulator said.
The drug costs £12.90 per 75 mg tablet (excluding VAT), with a recommended dosage of 75 mg as needed, not more than once daily.
NICE emphasised that the new recommendation was not intended to affect treatment with rimegepant 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, it underlined.
"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," Ms Knight stated.
NICE acknowledged that rimegepant could "eventually be used in primary care" but said it should initially be started in secondary care.
Commenting for Medscape News UK, Robert Music, chief executive of The Migraine Trust, said that the decision from NICE provided people with migraine "valuable options" and that it brought "new hope".
NICE said it expected to publish its final recommendations on rimegepant in October this year.