electroCore Announces Publication Reviewing the Prescribing of gammaCore for the Treatment of Cluster Headache in England

Rhea-AI Summary

On October 20, 2021, electroCore, Inc. (Nasdaq: ECOR) announced a peer-reviewed study in the British Journal of Healthcare Management evaluating prescribing trends for gammaCore in treating cluster headaches in England from April 2019 to 2020. The study involved 655 patients, revealing that 46.3% continued treatment with at least one refill and 30.9% required two or more refills. This suggests a durable benefit of gammaCore's non-invasive vagus nerve stimulation (nVNS) therapy. The NHS’s reimbursement program and favorable cost-saving implications were also highlighted.

Positive

• Study shows 46.3% of patients continued gammaCore treatment with at least one refill.
• 30.9% of patients required two or more refills, indicating treatment adherence.
• Potential cost savings associated with gammaCore usage recommended by NHS.

Negative

• None.

ROCKAWAY, NJ, Oct. 20, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper entitled “Non-invasive vagus nerve stimulation for treatment of cluster headache: a retrospective review of prescribing in England,” in the British Journal of Healthcare Management. The paper reviews the prescribing trends of gammaCore in England from April 2019 through the end of 2020. gammaCore was listed on NHS England and Improvement’s ‘Innovation Technology Payment’ program beginning 1^st April 2019, which provided for the reimbursement of gammaCore for cluster headache patients in England. This program followed the National Institute for Health and Care Excellence recommendation for the use of gammaCore in cluster headache.

The study is one of the largest clinical audits of patients with cluster headache and highlights that of the 655 patients who started on gammaCore, 46.3% of patients were prescribed at least one refill and 30.9% were prescribed two or more refills. These real-world results suggest a durable benefit for patients utilizing gammaCore’s non-invasive vagus nerve stimulation (nVNS) for cluster headache in England.

Dr. Nick Silver, Consultant Neurologist at The Walton Centre NHS Foundation Trust and lead author of the paper commented, “Clinically, our goal is to find a treatment that works well and works consistently for our patients with cluster headache. This study demonstrates our patients’ ability to maintain gammaCore treatment through multiple 3-month refill cycles, showing that non-invasive vagus nerve stimulation is efficacious, tolerable, and practical for patients with cluster headache.”

“We congratulate and thank the authors, NHS Centers, and patients who contributed to this study,” commented Iain Strickland, Vice President of Global Sales and Strategy at electroCore. “After using gammaCore for 3 months, nearly 50% of patients continue treatment highlighting nVNS’ practical benefit in a condition with limited therapeutic options. Furthermore, adoption and successful use of gammaCore in cluster headache patients has been shown to deliver cost savings as recommended by the NHS.”

The full publication is available at: https://www.magonlinelibrary.com/journal/bjhc

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company's current indications are the preventive treatment of cluster headache and migraine, the acute treatment of migraine and episodic cluster headache, the acute and preventive treatment of migraines in adolescents, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore^TM
gammaCore^TM (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 (nVNS) 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, the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients, and paroxysmal hemicrania and hemicrania continua in adults. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Adolescent patients with congenital cardiac issues
• 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 (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s expectations for revenue and cash used in operations during the third quarter of 2021, its expectations for future performance, as well as electroCore's business prospects and clinical and product development plans for 2021 and beyond, its pipeline or potential markets for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to Canada, Western Europe, Qatar, Taiwan, and China) and other statements that are not historical in nature, particularly those that utilize terminology such as "anticipates," "will," "expects," "believes," "intends," other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

FAQ

What does the recent study about gammaCore reveal?

The recent study indicates that 46.3% of cluster headache patients continued treatment with gammaCore, suggesting its durable benefits.

How many patients were included in the gammaCore study?

The study reviewed prescribing trends for a total of 655 patients using gammaCore.

What is the significance of NHS reimbursement for gammaCore?

NHS reimbursement supports the usage of gammaCore, enhancing its accessibility for cluster headache treatment in England.

What are the findings regarding patient adherence to gammaCore treatment?

The study found that 30.9% of patients needed two or more refills, indicating strong treatment adherence.

When was gammaCore included in the NHS reimbursement program?

gammaCore was included in the NHS England and Improvement’s reimbursement program starting April 1, 2019.