Members Will Receive Access to Theranica's Prescribed Wearable Device
MONTCLAIR, N.J., Dec. 12, 2022 /PRNewswire/ -- Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, announced today that Highmark Inc. (Highmark), one of America's leading health insurance organizations and an independent licensee of the Blue Cross Blue Shield Association, will conduct a targeted Coverage with Evidence program with the goal of providing its members with affordable treatment for episodic and chronic migraine.
Under the new program, Highmark members prescribed by providers participating in the program will receive access to Nerivio®, the first FDA-cleared, prescribed, digitally connected, drug-free wearable device for the acute treatment of episodic and chronic migraine in individuals aged 12 and older.
"With more than 37 million Americans suffering from migraine, a debilitating disorder that significantly impacts quality of life, we are glad to be able to offer Nerivio, a drug-free, clinically validated treatment option," said Andrea Synowiec, DO, FAAN, System Vice Chair, Department of Neurology, Associate Professor of Neurology and Assistant Director of the headache center of The Allegheny Health Network, a non-profit, academic medical system owned by Highmark Health.
Dr. Synowiec is the medical lead of this Coverage with Evidence program. "Nerivio is an excellent treatment option for our patients with migraine, especially those who do not respond to medications, or cannot tolerate their side effects. It's also effective for teenagers who struggle with migraine and gives them a drug-free treatment option. This program demonstrates Highmark's ongoing commitment to increasing access to necessary medical devices and treatments to their members."
Clinical studies have shown Nerivio to be as effective as standard of care pharmacological options for acute migraine treatment. Theranica recently published topline results of a pivotal trial demonstrating the efficacy and safety of Nerivio® also for the preventive treatment of migraine, currently under FDA review. Worn on the upper arm, Nerivio® utilizes remote electrical neuromodulation (REN) to trigger an endogenous descending pain inhibition mechanism, known as conditioned pain modulation (CPM) which aborts or alleviates migraine headache and associated migraine symptoms.
"As an advanced health insurance company, Highmark demonstrates its freedom from the obsolete paradigm that migraine could only be treated with drugs. When making their reimbursement decisions, they are looking at the actual clinical effectiveness and medical benefit exhibited by each therapy," said Alon Ironi, CEO of Theranica. "Recent scientific discoveries indicate that pain-inhibition mechanisms in the central neural system may be triggered by agents other than chemicals, as shown in many of our clinical studies. This is especially important in the case of migraine, where there isn't a "one fits all" solution. Often, treating this prevalent disease may require combination therapy.
Theranica is a prescribed digital therapeutics company dedicated to creating effective, safe, affordable, low-side effect therapies for idiopathic pain conditions. The company's award-winning flagship product, Nerivio®, is the first FDA-cleared smartphone-controlled prescribed wearable device for acute treatment of migraine, recently surpassed a quarter of a million treatments administered to date. Theranica is expanding its proprietary technology to develop solutions for additional idiopathic pain conditions. Nerivio has received FDA authorization and CE mark for use in acute treatment of episodic and chronic migraine in adult and adolescent patients and is currently under FDA review for preventive treatment of migraine.