electroCore Announces Positive Coverage Policies of gammaCore Issued by Highmark
26 Fevereiro 2019 - 10:00AM
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic
medicine company, today announced that Highmark, one of the
nation’s top health insurers and the third largest Blue Cross Blue
Shield affiliated company, has determined that non-implantable
vagus nerve stimulation device, gammaCore, may be medically
necessary for the abortive treatment of episodic migraine and
episodic cluster headaches. Highmark serves over 5 million patients
across Pennsylvania, Delaware, and West Virginia.
"This coverage announcement marks a significant step forward.
Highmark’s updated medical policy opens a new path to treatment
access for many patients suffering from migraine and cluster
headache,” said Frank Amato, chief executive officer of
electroCore, Inc. “We look forward to this expanded coverage and
will continue to work with providers, patients and doctors to build
upon our mission of helping patients who are suffering from the
debilitating effects of these disorders.”
About gammaCore™gammaCore™ (nVNS) is the first
non-invasive, hand-held medical therapy FDA-cleared as an
adjunctive therapy for the preventative treatment of cluster
headache and as an acute treatment for pain associated with
episodic cluster headache and migraine headache in adult patients.
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 leading to a modulation of
neurotransmitters and a reduction in pain.
gammaCore is the only therapy FDA cleared for the prevention of
cluster headache.
gammaCore is available by prescription only and patients should
speak with their doctor about whether gammaCore is right for
them.
gammaCore™ (non-invasive vagus nerve stimulator) is
intended to provide non-invasive vagus nerve stimulation (nVNS) on
the side of the neck. gammaCore is indicated for:
- Adjunctive use for the preventive treatment of cluster headache
in adult patients.
- The acute treatment of pain associated with episodic cluster
headache in adult patients.
- The acute treatment of pain associated with migraine headache
in adult patients.
- The safety and effectiveness of gammaCore (nVNS) have not been
established in the acute treatment of chronic cluster headache
- gammaCore has not been shown to be effective for the preventive
treatment of migraine headache
- The long-term effects of the chronic use of gammaCore have not
been evaluated
- Safety and efficacy of gammaCore have not been evaluated in the
following patients, and therefore it is NOT indicated for:•
Patients with an active implantable medical device, such as a
pacemaker, hearing aid implant, or any implanted electronic
device• Patients diagnosed with narrowing of the arteries
(carotid atherosclerosis)• Patients who have had surgery to
cut the vagus nerve in the neck (cervical vagotomy)• Pediatric
patients• Pregnant women• Patients with clinically
significant hypertension, hypotension, bradycardia, or
tachycardia
- Patients should not use gammaCore if they:• Have a
metallic device such as a stent, bone plate, or bone screw
implanted at or near their neck• Are using another device at
the same time (e.g., TENS Unit, muscle stimulator) or any portable
electronic device (e.g., mobile phone)
NOTE: This list is not all inclusive. Please refer to the
gammaCore Instructions for Use for all of the important warnings
and precautions before using or prescribing this product.
About electroCore, Inc. 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 preventative treatment of cluster headache
and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
Media ContactSara ZelkovicLifeSci Public
Relations(646) 876-4933Sara@lifescipublicrelations.com
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