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October 23, 2018

NICE Publishes Advice on gammaCore for the Treatment of Cluster Headache in the UK

electroCore, Inc. a global healthcare technology company, today announced that the National Institute for Health and Care Excellence (NICE) has published a Medtech Innovation Briefing (MIB) on their non-invasive vagus nerve stimulator (nVNS), gammaCore, for use in the treatment of cluster headache in adults. The report collates the most recent published evidence, and surmises that gammaCore is beneficial for people suffering with cluster headache. Clinical specialists propose that gammaCore has the potential to be a treatment option for people who haven’t responded to, or can’t tolerate currently available treatments.[1]  
 
Cluster headache is an excruciating primary headache disorder that is frequently nicknamed “suicide headache” due to its severity,[2] and has recently been recognised by the NHS as one of the top 20 most painful conditions known to man.[4] and affects approximately 66,000 people in the UK.
 

“Cluster headache can have a devastating impact on a person’s quality of life,” said Dr. Nick Silver, Consultant Neurologist, The Walton Centre. “The publication of this MIB means that healthcare professionals can now have the confidence to prescribe gammaCore for appropriate patients. The MIB indicates that gammaCore has no known side effects and is easy to use to help prevent cluster headache or alleviate their pain, enabling patients to engage in normal activities such as returning to work and spending time with their friends and families.”

A MIB is a report developed by NICE to support NHS and social care commissioners and staff who are considering using new medical devices and other medical or diagnostic technologies. The information provided includes a description of the technology, how it’s used and its potential role in the treatment pathway.

The opinion of three leading clinical experts and the advocacy group, Migraine Trust, were consulted in the development of the MIB. The report showed that the use of gammaCore alongside standard of care may be more effective than standard of care only in the treatment of cluster headaches. It also states that gammaCore does not need to be surgically implanted and does not require clinical monitoring.1  

“We are encouraged by the findings of the report which reiterate that gammaCore is an effective treatment option for adults with this highly debilitating condition,” said Francis R. Amato, Chief Executive Officer of electroCore. “Healthcare organisations using gammaCore can help to empower patients to take control of their condition by self-administering nVNS therapy. electroCore will continue to partner with NICE to ensure that our technology is routinely available to eligible patients on the NHS.”

gammaCore modifies pain signals by stimulating the vagus nerve through the transmission of a mild electrical signal. It can be used either to prevent cluster headache from occurring, or can be used to treat pain during a headache. As a hand-held, portable device, the technology allows patients to self-care from the comfort and privacy of a home environment, which could help to alleviate hospital-setting pressures.

About gammaCoreTM

gammaCore is a non-pharmacological self-care tool about the size of a mobile phone,[5] which modifies pain signals by stimulating the vagus nerve (the sensory information conduit between the body’s internal organs and the brain) via the transmission of a mild electrical signal. Conductive gel is applied to the stimulation surfaces of the device before placement on the neck. gammaCore then sends a mild electrical pulse to the brain via the vagus nerve with the aim of reducing the pain of a cluster headache. Each dose lasts for two minutes.

gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, and Hemicrania Continua) and Medication Overuse Headache in adults. gammaCore is also released/cleared, licensed, registered and/or approved in Australia, Canada, Colombia, Hong Kong, India, New Zealand, South Africa, the United States, and Vietnam.

About electroCore

electroCore is a global healthcare technology company focused on developing non-invasive vagus nerve stimulation (nVNS) therapy. As well as its key therapeutic focus in primary headache, the company has a robust programme of both pre-clinical and clinical work in other neurological conditions, psychiatry, respiratory, gastroenterology and secondary headache (medicine overuse and post traumatic headache). electroCore is headquartered in the United States and also has offices in UK and Germany. For more information, visit electrocore.com.

[1] NICE. Medtech Innovation Briefing. gammaCore for cluster headache.

[2] Torelli. Pain and behaviour in cluster headache. A prospective study and review of the literature. Funct Neurol. 2003 Oct-Dec;18(4):205-10

[3] NHS Choices. 20 Painful Health Conditions. Available at: https://www.nhs.uk/live-well/healthy-body/20-painful-health-conditions/ Accessed: September 2018

[4] Gaul, C., Finken, J., Biermann, J., Mostardt, S., Diener, H-C., Muller, O., Wasem, J., Neumann, A. Treatment costs and indirect costs of cluster headache: A health economics analysis.Cephalalgia: International Headache Society 2011, 31 (16): 1664–1672.

 

[5] electroCore, Inc. (2016). gammaCore: Instructions for Use for gammaCore®. Basking Ridge, NJ.