Draft NICE guidance has approved rimegepant, a novel oral drug for preventing migraine, which it said could become available to 145,000 NHS patients.
Rimegepant is the first drug of its class to come in pill form, with other similar medications administered as injections. The calcitonin gene-related peptide (CGRP) receptor antagonist was also the first of its class to be reviewed by NICE.
NICE’s draft guidance recommends rimegepant, made by Pfizer and traded under the name Vydura, as an option for preventing episodic migraine in adults where at least three previous preventive treatments have failed.
NICE has also published draft guidance for consultation that does not recommend rimegepant for treating acute migraine although Pfizer said it was providing additional evidence in a bid to overturn the interim decision.
Episodic migraine is where a person has fewer than 15 migraine days each month and NICE’s draft guidance recommends rimegepant for adults who have at least four migraine attacks per month but less than 15.
How does rimegepant work?
Rimegepant is a targeted migraine treatment licensed for the acute treatment of migraine, with or without aura in adults; or for the preventative treatment of episodic migraine in adults who have at least four migraine attacks per month.
It 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). CGRP causes intense inflammation in the coverings of the brain (the meninges) and is responsible for the severe pain associated with migraine attacks.
Sources: NICE and Pfizer
NICE said current treatments for preventing migraine – including beta-blockers, antidepressants and epilepsy medications – can have significant side effects and be ineffective.
Currently, treatments offered after these have been tried include injections erenumab, fremanezumab or galcanezumab.
NICE draft guidance said that if rimegepant is considered to be one of a range of suitable treatments, the least expensive option should be used following discussion with the patient about advantages and disadvantages of all the options.
NICE expects to publish final guidance next month (5 July), if it receives no appeals from Pfizer, patients or professional groups.
NICE director of medicines evaluation Helen Knight said: ‘Each year the lives of millions of people in England are blighted by migraine attacks. They can be extremely debilitation 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.
‘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.’
The Migraine Trust highlighted that as opposed to conventional acute treatments such as triptans, non-steroidal anti-inflammatory drugs (NSAIDs), and other painkillers, the group of drugs that rimegepant belongs to (commonly called the gepants( do not seem to cause rebound headache (medication overuse headache).
It said medication overuse headache is a significant problem for people with migraine, with a 2019 survey by the trust of of 1,800 people finding that migraine medication had caused medication overuse headache in a third (34%) of patients.
It also said it hopes NICE will reconsider its draft decision not to recommend rimegepant for acute migraine, highlighting that the Scottish Medicines Consortium recently approved it for this use within NHS Scotland.
It is thought that over 5.6 million people in England have episodic migraines, with an estimated 190,000 migraine attacks experienced every day.