electroCore, a global healthcare technology company, has announced that the National Institute for Health and Care Excellence (NICE) has published a Medtech Innovation Briefing (MIB) on its 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.
Cluster headache is an excruciating primary headache disorder that is frequently nicknamed “suicide headache” due to its severity, and has recently been recognised by the NHS as one of the top 20 most painful conditions known to man. 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.
“Cluster headache is one of the most severe and under-recognised types of pain known to mankind,” said 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.
“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 ifficer 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.”
