NICE publishes advice on gammaCore for the treatment of cluster headache in the UK
09 Novembro 2018 - 11:40AM
Report contributors agreed gammaCore was
highly innovative, may be more effective than standard of care
alone, and has the potential to save money through the NHS by
reducing the cost of treating cluster headache
electroCore, Inc., commercial-stage bioelectronic 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 recognized 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 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 organizations 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 gammaCore™
gammaCore™ (nVNS) is the first non-invasive, hand-held medical
therapy applied at the neck that acutely treats the pain associated
with episodic cluster headache and migraine in adult patients
through the utilization of a mild electrical stimulation to the
vagus nerve that passes through the skin. Designed as a portable,
easy-to-use technology, gammaCore can be self-administered by
patients, as needed, without the potential side effects associated
with commonly prescribed drugs. When placed on a patient’s neck
over the vagus nerve, gammaCore stimulates the nerve’s afferent
fibers, which may lead to a reduction of pain in patients.
gammaCore is released/cleared in the U.S. for the
acute treatment of pain associated with episodic cluster headache
and migraine headache in adult patients.
About electroCore
electroCore, Inc. is a commercial-stage bioelectronic medicine
company dedicated to improving patient outcomes through its
platform non-invasive vagus nerve stimulation therapy initially
focused on the treatment of multiple conditions in neurology and
rheumatology. The company’s initial targets are the acute treatment
of migraine and episodic cluster headache.
For more information,
visit www.electrocore.com.
Investors: Greg Chodaczek or Lynn Lewis
Gilmartin Group (646)
924-1769 investors@electrocore.com
Media Contact
Alexandra Canale GCI Health (617) 921-9353
alexandra.canale@gcihealth.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.
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