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12th April 2024
Atogepant (brand name Aquipta), the first oral drug for chronic and episodic migraine prophylaxis where other treatments have failed should be available on the NHS, according to final draft guidance from NICE.
Up to 170,000 people could be eligible for atogepant, which is manufactured by AbbVie, under the recommendations.
This follows the approval of atogepant by the European Commission in August 2023 for chronic and episodic migraine prophylaxis in adults. The Scottish Medicines Consortium also accepted atogepant for restricted use in suitable patients in October 2023.
With this latest recommendation, it is expected that use of the drug, which works by blocking the calcitonin gene-related peptide receptor (CGRP), will be initially managed in secondary care, under a commercial agreement agreed with NICE.
But in the evidence provided to the appraisal process, drug manufacturer AbbVie noted there was potential for it to be monitored in primary care, and for follow-up appointments to be done by GPs.
Patient and professional organisations also told the committee that the availability of atogepant through GPs would improve access to treatment and reduce NHS costs.
The committee said that while atogepant would initially be prescribed and monitored in secondary care, ‘there would be interest in being able to use it in primary care’.
Under the recommendations outlined in the final draft guidance, the oral, once-daily atogepant will be an option for chronic and episodic migraine prophylaxis in adults who have had at least four migraine days per month.
To be eligible for the drug, patients must also have tried at least three previous preventive treatments.
Atogepant may be useful for those who cannot tolerate current fourth-line injectable treatments or who have contraindications to them, the guidance said.
The drug should be stopped after 12 weeks if the frequency of migraine attacks does not stop by at least 50% for episodic migraine and at least 30% for chronic migraine, NICE said.
It is also considered to be one of a range of suitable treatments and, after discussing the advantages and disadvantages of all the options, the least expensive should be used, NICE added.
Professor Peter Goadsby, honorary consultant neurologist, King’s College Hospital, said: ‘We know that people living with migraine may battle for years without an effective treatment to mitigate the daily struggles of living with this debilitating condition.
‘The decision by NICE should have a positive impact on patients who are eligible to receive atogepant as the treatment has been shown to reduce significantly the number of mean monthly migraine days in pivotal trials.
‘This welcome news increases the treatment options available that clinicians can offer to suitable patients, providing them with access to an additional preventive treatment that is now available on the NHS in England and Wales.‘
The NICE recommendation is supported by data from three pivotal Phase 3 clinical studies evaluating atogepant 60 mg once-daily in adults living with episodic (ADVANCE and ELEVATE) and chronic (PROGRESS) migraine.
In the three trials, the treatment met the primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks versus placebo. Additionally, the treatments achieved significant reductions from baseline in several secondary efficacy endpoints compared to placebo: mean monthly headache days and mean monthly acute medication days, along with an additional achievement of ≥50% reduction in three-month average of monthly migraine days in the ELEVATE study.
Atogepant was also found to be generally well tolerated.
The most commonly reported adverse reactions in the ADVANCE and PROGRESS trials were nausea (7%), constipation (7%) and fatigue/somnolence (5%).
For the ELEVATE study, treatment-emergent adverse events were reported by 81 participants (52%) in the atogepant group (n=156). The most common (≥5%) were constipation (10%), Covid-19 (8%), nausea (7%), and nasopharyngitis (5%).
NICE director of medicines evaluation Helen Knight said: ‘[The] final draft guidance demonstrates our commitment to focusing on what matters most and getting the best care to people while ensuring value for the taxpayer.
‘Currently, the most effective options for people with chronic migraines who have already tried three preventative treatments are drugs that need to be injected.
‘The committee heard from patient experts that some people cannot have injectable treatments, for example because they have an allergy or phobia of needles. So, some people with chronic migraines would welcome an oral treatment. Atogepant also offers more choice for people with episodic migraine.’
Rob Music, chief executive of the Migraine Trust, added: ‘A migraine attack can be incredibly debilitating. Symptoms can include intense head pain, loss of or changes to senses and lack of ability to carry out day to day life.
‘It is positive to see even more therapies emerging for people with migraine after many still rely on treatments developed for other conditions. We now need to ensure access to the newer treatments is swift, so that migraine patients can benefit from them.‘
If there are no appeals, the final NICE guidance is expected to be published on 15 May 2024.
Last year, NICE recommended rimegepant as the first oral treatment for episodic migraine and acute migraine, in draft guidance published in June and September, respectively.
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.’
19th December 2022
The identification of enlarged perivascular spaces in the centrum semiovale in patients with migraine compared to healthy controls, is suggestive of a disruption in the glymphatic system according to the findings of a study using ultra-high-field 7T MRI and presented at the Radiological Society of North America conference 2022.
Migraine is a common headache-related condition that affects an estimated 12% of the population. With the development of magnetic resonance imaging, it has become clear that some migraine patients (both with and without aura) are at an increased risk for subclinical lesions in certain brain areas. Such lesions include white matter hyper-intensities (WMH), i.e., lesions that have infarction features but which do not cause any clinical symptoms or other stroke-related signs. In addition, cerebral micro-bleeds (CMBs) are another biomarker of small-vessel disease and which have been found to co-occur with infarcts more often in migraine than in control patients. Advances in imaging techniques by 7 Tesla MRI might improve the visualisation of smaller anatomical structures and allow detailed pathological findings with a high spatial resolution by reducing the voxel size related to the increased signal-to-noise (SNR) ratio.
In the present study, US researchers used the 7T MRI modality to study microvascular changes in the brain due to migraine, particularly in perivascular spaces and compared the findings with those seen in headache-free control patients. They enrolled participants with both chronic migraine (CM), episodic migraine without aura (EMWoA) and age matched healthy controls. Patients were excluded if they had overt cognitive impairment, a brain tumour, prior intracranial surgery, contraindications to MRI or if they suffered with claustrophobia. The team calculated enlarged perivascular volume spaces (EPVS) in the centrum semiovale (CSO) and basal ganglia (BG), WMH using the Fazekas scale, and CMB using the micro-bleed anatomical rating scale. In addition, they also collected clinical data such as disease duration and severity, symptoms at time of scan, presence of aura, and side of headache.
Enlarged perivascular spaces in migraine and control patients
A total of 10 CM, 10 EMWoA and 5 health control participants were included.
The results showed that the number of EPVS in the CSO, but not in the BG, was significantly higher with migraine compared to healthy controls (p = 0.04). However, while the frequency of WMH and CMB in migraine did not significantly differ from controls, among migraine patients, there was a significant correlation between EPVS quantity in CSO and deep WMH severity (p = 0.04).
The authors concluded that there were significant differences in the EPVS in migraine compared to controls and which might indicate be suggestive of glymphatic disruption, i.e., the system for clearance of waste materials from the central nervous system and which utilises perivascular channels. Nevertheless, whether such changes affect migraine development or result from migraine is unknown.
In a related press release, study co-author Wilson Xu, from Keck School of Medicine of the University of Southern California in Los Angeles, said ‘although we didn’t find any significant changes in the severity of white matter lesions in patients with and without migraine, these white matter lesions were significantly linked to the presence of enlarged perivascular spaces. He added how ‘this suggests that changes in perivascular spaces could lead to future development of more white matter lesions.’
Citation
Xu W et al. Migraine-Associated Vascular Changes on Structural 7T-MRI. RSNA 2022
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