Vydura is first NICE-backed oral GPCR for acute migraine

Pfizer's Vydura has become the first drug in the oral GPCR receptor antagonist class to be recommended for routine NHS use as a treatment for acute migraine.

The drug has been given a positive opinion by cost-effectiveness appraiser NICE as an option for adults with acute migraine, with and without aura, if they have been unable to get sufficient relief from prior therapies.

Specifically, patients will need to have tried at least two triptan-based therapies, which either did not work well enough, were not well tolerated or contraindicated, and have migraine that does not respond to non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol.

Despite the limitations, it is estimated that as many as 13,000 acute migraine patients could be eligible for treatment with Vydura (rimegepant).

The drug was also the first oral CGRP therapy recommended for routine use by the NHS to prevent episodic migraine attacks, getting authorised by NICE for this use in May.

At that time, Vydura was also considered for acute use, but was turned down by NICE's appraisal committee on the grounds that it was too expensive to be cost-effective. The drug – which dissolves under the tongue – has a list price of £12.90 per 75 mg tablet, according to NICE's final appraisal document (PDF) published this morning.

Earlier this week, Vydura was also approved for use by NHS Scotland as a preventative treatment of episodic migraine by the Scottish Medicines Consortium (SMC), which backed acute use of the drug in May, ending a disparity in access within the UK.

It is estimated that one in seven people in the UK are living with migraine, which along with severe headache can cause vomiting, nausea, disturbed vision, fatigue, and sensitivity to light, sound, and smells.

The news has been welcomed by the Migraine Trust, which said that - unlike triptans, NSAIDs, and other painkillers - oral 'gepants' like Vydura don't seem to cause medication overuse headache. That is a significant problem for people with migraine, occurring in around a third of patients, according to a 2019 survey by the patient organisation.

Furthermore, people with cardiovascular disease will be able to take Vydura as, unlike triptans, it does not constrict or tighten blood vessels. That means access to the drug will answer a pressing unmet need for these patients, as NSAIDs and paracetamol often fail to be effective in acute migraine.

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."

An estimated 43 million workdays are lost each year in the UK to migraine-related absenteeism. Other estimates suggest migraine may cost the UK economy between £6 billion and £10 billion per year in total healthcare and productivity costs.