The new policy, titled, MedTech Funding Mandate Policy 2021/22, which goes into effect on 1st
“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
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 ofEngland ;
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.
About gammaCore™
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
- 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.
Forward-Looking Statements
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
Investors:
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or
Media Contact:
electroCore
973-290-0097
jackie.dorsky@electrocore.com
Source: electroCore
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