Millions of people with regular migraines could be offered the first ever dedicated oral treatment on the NHS.
More than six million Brits suffer “episodic migraines” with at least four severe headaches a month.
Until now they were offered drugs for other linked conditions - such as beta-blockers, antidepressants and epilepsy medications - or injections.
Now the National Institute for Health and Care Excellence (NICE) has approved a drug called Rimegepant in England which is taken as a wafer which dissolves under the tongue.
It works by stopping the release of a protein around the brain called calcitonin gene-related peptide (CGRP) which causes intense inflammation in the coverings of the brain.
Around 150,000 patients with episodic migraines, where at least three previous treatments have failed, will be offered the drug.
Helen Knight, director of medicines evaluation at NICE, said: “Each year the lives of millions of people in England are blighted by migraine attacks.
“They can be extremely debilitating and can significantly affect a person’s quality of life. In comments received during consultation on the previous draft guidance, patients and carers described migraine as an invisible disability that affects all aspects of life including family, social activities, mental health, finances and education.”
Around 10 million people in the UK suffer some form of migraines.
They affect three-times as many women as men, likely due to the differences in sex hormones. Migraine affects one in 10 children.
NICE’s draft guidance recommends rimegepant - also called Vydura and developed by drugmaker Pfizer - as a preventative treatment for adults who have at least four migraine attacks per month but less than 15.
Clinical trial evidence showed it worked better than a dummy treatment at reducing the headache attacks.
Current treatment options such as beta-blockers, antidepressants and epilepsy medications can have significant side effects and can be ineffective for some people.
The Migraine Trust welcomed the NICE announcement but called for Rimegepant to be offered more widely.
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.
“While we welcome that it has been approved for the preventive treatment of migraine, we are very disappointed by the decision not to approve it for the acute treatment of migraine.”
There are an estimated 190,000 migraine attacks every day in the UK and until recent years there had been very little understanding of what causes them.
The coverings of the brain called the meninges are thought to be responsible for some forms of severe pain associated with migraines.
The CGRP protein transmits pain signals along the trigeminal nerve into the brain and can cause severe inflammation of the meninges.
Previously the only specific treatment for migraines were injections of monoclonal antibodies, the same technique used to boost the body’s immune system in Covid-19 patients.
NICE-recommended erenumab, fremanezumab or galcanezumab are antibody proteins engineered to target and neutralise other proteins or their receptors.
So these injections target the CGRP protein or its receptor.
Helen Knight added: “Rimegepant is the first oral treatment for migraine to be recommended by NICE and for many thousands of people it is likely to be a welcome and more convenient addition to existing options for a condition that is often overlooked and undertreated.
“Today’s draft guidance demonstrates our commitment to focusing on what matters most and getting the best care to people while ensuring value for the taxpayer.”
Patient and professional groups now have the opportunity to appeal against the draft guidance. If no appeals are received final guidance is expected to be published next month.
