ElectroCore Announces Positive Coverage Policies of GammaCore Issued by HighMark
GammaCore may be medically necessary for the abortive treatment of episodic migraine and episodic cluster headaches
BASKING RIDGE, N.J., Feb. 26, 2019 (GLOBE NEWSWIRE) — 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.”
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.