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NICE publishes advice on gammaCore for the treatment of cluster headache
Report contributors agreed gammaCore was innovative and it has the potential to save money through the NHS by reducing the cost of treating cluster headache
BASKING RIDGE, N.J., Oct. 22, 2018 (GLOBE NEWSWIRE) -- electroCore, 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, and prevention, of cluster headache in adults. The report collates the most recent published evidence, and surmises that the use of gammaCore alongside standard of care may be more effective than standard of care only in the treatment of cluster headaches 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.3 It is estimated to cost the NHS in England more than £10,000 a year per patient,4 and affects approximately 66,000 people in the UK.1
“Cluster headache is one of the most severe and under-recognised types of pain known to mankind,” says Dr Nicholas Silver, Consultant Neurologist at The Walton Centre, Liverpool. “Patients may suffer for years without the correct diagnosis or treatment, and women are less likely to be recognised. Recurrent unilateral headache attacks with eye, nose and ear symptoms, agitation, sleep and mood disturbance typically cause severe disability and impact dramatically on patients, family, friends and work. The NICE publication draws on significant clinical and research experience that recognises gammaCore as an effective, non-invasive handheld device with no known serious side effects. This is a great step forward as it will undoubtedly significantly improve the lives of many sufferers.”
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 four leading clinical experts and the advocacy group, Migraine Trust, were consulted in the development of the MIB. The report contributors noted that the use of gammaCore has led to improvements for some people, allowing them to return to work and resume normal activities. It is also stated that gammaCore is easy to use, does not need to be surgically implanted and requires no 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.
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 surface 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.
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.
020 707 24215
1 NICE. Medtech Innovation Briefing. gammaCore for cluster headache. Available at: https://www.nice.org.uk/advice/mib162. Accessed October 2018
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 October 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 (2016). gammaCore: Instructions for Use for gammaCore®. Basking Ridge, NJ.