NICE backs AQUIPTA for acute migraine treatment in England and Wales

The National Institute for Health and Care Excellence (NICE) has recommended AQUIPTA (atogepant) as an NHS treatment option for adults with acute migraine in England and Wales who have not benefited from existing therapies.

The recommendation, issued in Final Draft Guidance, follows the recent granting of a marketing authorisation by the Medicines and Healthcare products Regulatory Agency for atogepant in the acute treatment setting.

Under the guidance, atogepant can be offered to adults with migraine with or without aura if at least two triptans have failed to provide sufficient benefit, are not tolerated or are contraindicated, and nonsteroidal anti-inflammatory drugs and paracetamol have also proved ineffective.

The decision provides a new treatment option for patients whose migraine attacks remain difficult to manage despite existing acute therapies.

Migraine affects an estimated 10 million people in the UK and is one of the leading causes of disability worldwide. Symptoms can include severe headache, nausea, vomiting and sensitivity to light and sound, often disrupting work, family life and social activities.

Rob Music, chief executive officer of the Migraine Trust, said: “Access to appropriate care for people with migraine can be seriously inconsistent, creating a postcode lottery. Many people with migraine tell us they have struggled to access treatments or had to wait a long time before they could see a specialist.

“That is why it is so important that there are a variety of treatments available and clinicians have clear guidance on how they should be prescribed. We therefore welcome today’s update from NICE, which adds an additional treatment option for eligible migraine patients.”

The recommendation is supported by results from the Phase 3 Eclipse study, which evaluated the safety, efficacy and tolerability of atogepant in adults with migraine with or without aura.

In the study, 24.3% of patients treated with atogepant achieved pain freedom two hours after dosing during their first migraine attack compared with 13.1% of patients receiving placebo.

The trial also demonstrated statistically significant improvements across multiple secondary endpoints, including sustained pain relief at both 24 and 48 hours after treatment.

Professor Alex Sinclair, professor of neurology at the University of Birmingham and chair of the British Association for the Study of Headache council, said: “The NICE recommendation means an additional treatment option for suitable individuals experiencing acute migraine attacks.

“This treatment option will allow clinicians to consider a wider range of approaches when managing acute migraine.”

Atogepant is an oral calcitonin gene-related peptide receptor antagonist. The treatment is already licensed in the UK for migraine prevention in adults experiencing at least four migraine days per month and has now also secured regulatory approval for acute treatment.

The NICE recommendation means eligible patients in England and Wales are expected to gain NHS access to atogepant as an acute treatment option following publication of final guidance.

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