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First oral drug for chronic and episodic migraine prophylaxis gets NICE go-ahead

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and episodic migraine prophylaxis where other treatments have failed should be available on the NHS, according to final draft guidance from NICE.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’.

Atogepant indication

Under the recommendations outlined in the final draft guidance, the oral, once-daily atogepant will be an option for chronic and episodic migraine prophylaxis in adults who have had at least four migraine days per month.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.‘

Efficacy and tolerability of atogepant

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%).

More choice for people with chronic migraine

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.