Theranica's REN Wearable Becomes the First Ever Non-Pharmacological Migraine Treatment to Receive Commercial Coverage in the USA

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Feb 20, 2024, 09:38 ET

Highmark Inc. Publishes Commercial Coverage Policy for Nerivio^®,
a Drug-Free, Dual Use Treatment for Adolescents and Adults Living with Migraine

BRIDGEWATER, N.J. and NETANYA, Israel, Feb. 20, 2024 /PRNewswire/ -- Theranica, a pioneering prescribed digital therapeutics company specializing in neuromodulation devices for migraine and other idiopathic pain conditions, announced the inclusion of its Nerivio Remote Electrical Neuromodulation (REN) wearable, for use in the acute and preventive treatment of migraine, under a commercial coverage policy of Highmark Inc (Highmark). This pivotal decision by Highmark follows the successful completion of its Coverage with Evidence Development (CED) program with Nerivio, launched in November 2022. The new commercial coverage policy marks a significant advancement in the accessibility of an effective, non-disruptive, and drug-free treatment for migraine, demonstrating Theranica's commitment to transforming the landscape of migraine care. With its flagship product, the Nerivio^®REN wearable, Theranica has been a transformative force in the treatment of migraine, a debilitating neurological condition affecting 1 billion people worldwide, including 10% of children and adolescents.

Nerivio is indicated for dual-use in people 12 years and older

Professor Christopher Gottschalk, MD, FAHS, Neurology Division Chief and Director of the Headache & Facial Pain Center at Yale University and the President of the Alliance for Headache Disorders Advocacy (AHDA), welcomed this coverage policy: "Americans with chronic conditions like migraine have faced a longstanding need for insurance coverage of neuromodulation devices and other non-pharmacological treatments. Nerivio is an evidence-based treatment that is supported by well-controlled trials, and this coverage policy is an encouraging milestone. We at the AHDA have high hopes that other US commercial insurers and Federally funded insurance plans will follow the very sensible footsteps of Highmark and recognize the importance of providing the 40 million Americans living with migraine with affordable access to drug-free prescription migraine treatments with clinical benefits properly backed by high-quality data."

Highmark's coverage decision for the Nerivio REN wearable follows a rigorous CED study with the device, assessing its clinical benefits over 384 members living with migraine. In the primary endpoint of the study, Nerivio demonstrated statistically significant results in the reduction in Migraine Disability Assessment Score (MIDAS) from 64.0 to 43.9 points (p<0.005). Additional clinically meaningful benefits were demonstrated with 75.8% of the participants experiencing pain relief within 2 hours post-treatment, 37.3% reporting pain freedom, 69.0% indicating functional disability relief, and 52.4% specifying full return to functional ability post 2 hours.

Andrea Synowiec, DO, FAAN, Vice Chair of the Department of Neurology at Allegheny Health Network in Pennsylvania, who led the CED program as the primary investigator, said, "The CED study shows statistically significant and clinically meaningful benefits to migraine patients treated with the REN wearable in a real-world environment. This data highlights the importance of including REN among migraine therapies covered by insurance to address the unmet need for effective, safe, easy-to-use migraine intervention."

Highmark Inc. and its Blue-branded affiliates proudly cover the insurance needs of approximately 7 million members in Pennsylvania, Delaware, New York, and West Virginia. Highmark's decision, backed by solid analysis of reliable data, opens doors for individuals grappling with the challenges of migraine disease to access an innovative and clinically proven solution for both acute and preventive migraine management.

Alon Ironi, CEO and co-founder of Theranica, emphasized the significance of this coverage decision, stating, "This is a huge milestone in our global commitment to improving the quality of life of adolescents and adults living with this chronic disease. US health insurance companies have traditionally neglected non-pharmacological therapies for migraine. Highmark broke that barrier with a scientific approach: they initiated a carefully planned CED study, which allowed their medical and policy team leaders to quantitatively analyze the clinical benefits of the REN wearable, and thus verify the contribution of this therapy. This is a wake-up call for other Payors in the US to stop depriving affordable access to quality therapies from people living with migraine, especially for younger patients, who have much fewer FDA-authorized options to treat and prevent migraine."

About Nerivio
Controlled by a smartphone app and self-administered, the Nerivio REN wearable is a complete migraine care treatment that wraps around the upper arm and uses sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerve fibers in the arm. These fibers send signals that trigger a descending pain management mechanism in the brain called conditioned pain modulation (CPM), which turns off migraine pain and associated symptoms without medication. In simpler terms, the upper arm is stimulated to unleash a natural process in the brain to abort or relieve migraine headaches and other associated symptoms. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment.

About Theranica
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 wearable, Nerivio^®, is the first FDA-cleared prescribed migraine REN Wearable for acute and/or preventive treatment of migraine Nerivio has been used in more than 650,000 migraine treatments in the US, including by adolescents and veterans living with migraine. Theranica is expanding its proprietary technology to develop solutions for additional idiopathic pain conditions. Learn more by visiting our websites, theranica.com and nerivio.com, and following us on LinkedIn, Twitter, Instagram and Facebook.
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SOURCE Theranica