NICE Issues Draft Guidelines on the use of GammaCore for Cluster Headache
The UK’s National Institute for Health and Care Excellence (NICE) draft guidance recommends the use of gammaCore for cluster headache in the National Health Service (NHS)
In the draft guidance, NICE highlights that the use of gammaCore in addition to standard care therapy could save the NHS £450 ($563) per patient in the first year compared to standard care alone. The guidance also states that gammaCore should be used following a three-month trial period where it has shown to be effective in reducing cluster headache symptoms. Additionally, clinical experts suggest that around 25,000 people in the U.K. with cluster headache are likely to respond to treatment with gammaCore.
“Cluster headache is a devastating disorder that affects around 100,000 people in the U.K.,” said Iain Strickland, managing director at electroCore UK, Ltd. “We are encouraged by the draft guidance and will continue to diligently work with NICE and the U.K. cluster headache community to ensure that the final guidance is equally as supportive.”
In order to finalize its medical technology guidance documents, NICE will solicit comments from stakeholders on the draft guidance. After the end of this consultation period, the review committee will meet to discuss whether to amend its draft recommendations in view of the consultation comments. Consultation on the draft gammaCore recommendations will close at 5:00 p.m. GMT on August 2, 2019 and the final guidance is expected to be published on November 22, 2019.
gammaCore™ (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache 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 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 FDA cleared in the United States 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, and the acute treatment of pain associated with migraine headache in adult patients.
- The effectiveness of gammaCore (nVNS) has 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
- 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 UK, Ltd.
electroCore UK, Ltd. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation (nVNS) therapy initially focused on the treatment of multiple conditions in neurology and rheumatology. The company’s primary focus in the UK is the use of gammaCore for the treatment of cluster headache and migraine. electroCore UK, Ltd. is a subsidiary of electroCore, Inc. Basking Ridge, New Jersey, USA.
For more information, visit electrocore.com.