9 July 2019

Device for Preventing and Relieving Pain of Cluster Headaches Approved by NICE in Draft Guidance

A handheld device that delivers a small electric current has been recommended by NICE for the prevention and treatment of cluster headaches, a rare but painful type of headache that affects around 100,000 people in the UK.

The recommendation is made in NICE’s draft medtech guidance published today (5 July) for public consultation. It highlights that using gammaCore in addition to standard care (sumatriptan, zolmitriptan and oxygen) could save the NHS £450 per patient in the first year compared to standard care alone.

The guidance says that, because gammaCore is not effective in all patients with cluster headache, it should only be used following a 3-month trial period where it has been shown to be effective in reducing symptoms. Clinical experts suggest that around 25% of people in the UK with cluster headache – around 25,000 – are likely to respond to treatment with gammaCore.

gammaCore aims to modify pain signals by stimulating the vagus nerve through the skin of the neck and can be used to stop pain when the person feels a cluster headache beginning or daily to help prevent cluster headaches. The device is small and portable and, after brief training, is designed to be used anywhere that is convenient.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: “Cluster headaches are excruciatingly painful and debilitating and can have a huge effect on a person's life including affecting their ability to work or do normal activities.

“Many people with the condition don’t get enough pain relief with current treatment options, which are often used off-label and limited by side effects and contraindications. The committee heard that on average 5 people a year in the UK end their lives because they are no longer able to live with the pain of cluster headaches.i

“We’re pleased, therefore, to be able to recommend this innovative, simple to use treatment which has been shown to provide benefits for around a quarter of people who use it.

“And by decreasing the need for treatments to stop the symptoms of an acute attack of cluster headache, using gammaCore could be cost-saving for the NHS.”

Dr Sam Roberts, chief executive of the Accelerated Access Collaborative and director of innovation and life sciences for NHS England, said: “The health service has long been at the forefront of driving innovation, and as we start to deliver our ambitious Long Term Plan we want the NHS to be a world leader in adopting life-changing innovations.

“Today’s recommendation from NICE is a great endorsement for this device which the NHS is already offering free of charge to patients to help alleviate painful symptoms and empower them to claim back their ordinary daily lives.”

Consultation on the draft recommendations closes at 5:00 pm on 2 August 2019.

    • i. Submission from OUCH (Organization for the Understanding of Cluster Headache).