electroCore, Inc. Announces Inclusion of gammaCore Sapphire™ in new NHS England and NHS Improvement MedTech Funding Mandate Policy 2021/22
Policy, which goes into effect April 1, 2021, supports commissioners and providers in the use of selected NICE-approved, clinically effective and cost-saving medical devices, diagnostics and digital technologies that will improve patient outcomes
ROCKAWAY, N.J., Jan. 27, 2021 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that gammaCore Sapphire (nVNS) has been included in a new long-term reimbursement policy launched by Matthew Whitty, Director of Innovation Research and Life Sciences and Chief Executive of the Accelerated Access Collaborative, for and on behalf of NHS England and NHS Improvement (NHSEI).
The new policy, titled, MedTech Funding Mandate Policy 2021/22, which goes into effect on 1st April 2021, supports commissioners and providers in the use of selected National Institute for Health and Care Excellence (NICE)-approved, clinically effective and cost-saving medical devices, diagnostics and digital technologies that will improve patient outcomes. This policy will ensure that patients benefit by enabling faster and wider sustainable adoption of proven and affordable innovations, a commitment stipulated in the NHS Long Term Plan. Further, The NHS Standard Contract will require both commissioners and providers of NHS-funded services to comply, as relevant, with their obligations under, and any recommendations contained in, the MTFM.
“This policy represents a firm long-term commitment to ensure the appropriate use of gammaCore for patients with cluster headache,” said Iain Strickland, Vice President of European Operations at electroCore. “The MTFM policy will allow us to transition away from the Innovation and Technology Payment project, which necessitated shorter renewal cycles, and into sustained regional reimbursement arrangements across England. I am particularly pleased that the policy highlights a projection by NICE that further adoption of gammaCore could deliver cost savings to NHS of as much as £4,561,223 over the next five years. I look forward to a long and mutually beneficial partnership with NHS.”
To be included in the MTFM Mandate Policy 2021/22, products must have demonstrated that they:
- are effective: as demonstrated through positive NICE guidance (MTG or DG);
- are cost-saving in-year: NICE modelling demonstrates a net savings in the first 12 months of implementing the technology;
- are affordable to the NHS: the budget impact should not exceed £20 million, in any of the first three years;
- deliver material savings to the NHS: the benefits of the innovation are over £1 million over five years for the population of England;
The policy can be viewed online at the following link: https://www.england.nhs.uk/aac/wp-content/uploads/sites/50/2021/01/mtfm-policy-guidance-jan-2021.pdf
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. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.
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 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 treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. 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.
- Safety and efficacy of gammaCore have not been evaluated in the following patients:
- 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 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 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)
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19.
Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.
This press release and other written and oral statements made by representatives of electroCore 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 anticipated government funding arrangements provided and achievable by the NHS and NICE, electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the expected date of publication of complete study results from the PREMIUM II trial 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™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, 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.