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27th February 2023
In an appraisal consultation document from NICE, rimegepant is not being recommended within its marketing authorisation, for the acute treatment of migraine with or without aura in adults, or for the prevention of episodic migraine in adults, who experience at least 4 attacks per month.
Rimegepant belongs to a class of drugs referred to as ‘gepants’ which are calcitonin gene-related peptide receptor antagonists. Calcitonin gene-related peptide has been associated with sensitisation and pain generation but also plays a role in vasodilatation. In a recent phase 2/3 trial, oral rimegepant, when taken every other day, was found to be effective as a preventive treatment of migraine, with its tolerability similar to placebo.
It is proposed by the manufacturer that rimegepant is used for acute migraine treatment in patients who have failed to respond to two or more triptans. However, in its consultation document, while accepting that the drug is likely to reduce pain at 2 hours post-dose more than placebo, NICE added that the evidence submitted by the manufacturer, for patients who have not responded to two triptans, is uncertain and hence requires more evidence.
Moreover, while it also reduces monthly migraine days, NICE argued that there is an absence of comparative long-term evidence to support this view. As a result, the organisation believes that this clinical uncertainty affects the certainty of the cost-effectiveness estimate and which is likely to be above what NICE considers to be an acceptable use of NHS resources.
In response to the consultation, the Migraine trust has expressed concern, stating that ‘a significant proportion of those seeking help from The Migraine Trust have an inadequate response, or contraindication to the best current acute treatment triptans, or have medication overuse headache as a result of inadequate care and treatment of their migraine.’
The statement added that ‘we believe that Rimegepant is an important opportunity to help those who have medication overuse headache and prevent others from developing it.’ These concern arose following a 2019 survey of 1,800 migraine sufferers undertaken by the trust, which found that migraine treatments caused medication overuse headache in a third of respondents.
Chief executive of the migraine trust, Rob Music said that ‘we are very disappointed by this decision and urge those affected by migraine, and particularly those without an effective treatment for migraine and who have experienced medication overuse headache, to respond to NICE’s consultation and let it know how much this new treatment option [rimegepant] is needed.’
6th October 2021
Migraine is a common health problem which has been estimated to globally affect 1 in 7 people and occurs two-to three times more often in women. The main symptom of migraine is an intensive, often unilateral, moderate to severe throbbing headache. In addition, sufferers can also experience nausea and vomiting and some experience migraine with aura which gives rise to visual symptoms. The term episodic migraine, is used to define headaches which occurs on less than 15 days per month.
Acute treatment involves the use of 5HT1-receptor agonists (‘or triptans’) of which there are several e.g., sumatriptan. The underlying cause of migraine is unclear but calcitonin gene-related peptide (CGRP), a potent vasodilator, most likely plays an important role given how levels are increased during a migraine attack.
Studies suggest that blocking CGRP is therefore a potential treatment for episodic migraine and in fact, oral CGRP receptor antagonists (known as gepants) such as atogepant, represents a promising new therapy for migraine.
Clinical efficacy
The US FDA has approved the first and only gepant, atogepant (brand name Qulipta) for the preventative treatment of migraine in adults. The approval was based on a Phase III, double-blind trial in adults with an average of 4 to 14 migraine days per month. A total of 873 patients were randomised to atogepant 10, 30 and 60 mg (once daily) or placebo for 12 weeks and the primary endpoint was the change from baseline in the mean number of headache days per month. At week 12 there was a 55.6%, 58.7% and 60.8% reduction in the 3-month average of migraine days per month for the 10, 30 and 60mg atogepant groups respectively compared to 29% for the placebo arm (p < 0.001). All doses were well tolerated with the most common adverse effects including constipation (6.9 – 7.7% across doses) and nausea (4.4 to 6.1%).
Atogepant will be available from early October 2021.
Source. Abbvie Media News Centre
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