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

What You Should Know:

Theranica, a leader in neuromodulation devices for migraine and other chronic pain conditions, announced today that Highmark Inc. has included its Nerivio Remote Electrical Neuromodulation (REN) wearable in its commercial coverage policy for the acute and preventive treatment of migraine.

– Highmark’s coverage decision is a pivotal moment for migraine sufferers within their network. This opens doors for individuals previously limited by traditional treatment options to access a clinically proven, non-drug solution for both acute and preventive migraine management.

– The decision follows the successful completion of a Coverage with Evidence Development (CED) program with Nerivio, highlighting its clinical effectiveness and potential to improve patient outcomes.

Nerivio: A Transformative Drug-Free Option

Migraine affects over 1 billion people worldwide, including 10% of children and adolescents. It’s a debilitating neurological condition that can significantly impact daily life. Traditional treatment options often involve medication with potential side effects or limitations. Theranica’s Nerivio® REN wearable utilizes a non-invasive and drug-free approach to address migraine pain. The device works by delivering mild electrical pulses to the upper arm, triggering the body’s natural pain relief mechanisms. This innovative solution offers a welcome alternative for individuals seeking relief from debilitating migraine symptoms without the potential side effects of medication.

Highmark’s Rigorous Evaluation

Highmark’s decision to cover Nerivio wasn’t taken lightly. They conducted a comprehensive CED program, enrolling 384 members with migraine and evaluating the device’s clinical benefits over a defined period. The results were impressive:

– Significant reduction in pain: The study demonstrated a statistically significant decrease in Migraine Disability Assessment Score (MIDAS), a key measure of migraine severity.

– Fast and effective relief: 75.8% of participants experienced pain relief within 2 hours of using Nerivio.

– Improved function and quality of life: 37.3% reported pain freedom, 69.0% indicated functional disability relief, and 52.4% specified a full return to functional ability within 2 hours.

Highmark’s Decision: A Pivotal Step for Migraine Patients

Highmark’s coverage decision signifies a significant advancement in the accessibility of effective migraine treatment. It follows a rigorous CED study with 384 participants demonstrating Nerivio’s efficacy in reducing pain, improving function, and enhancing overall well-being.

Key results include:

– Statistically significant reduction in Migraine Disability Assessment Score (MIDAS), a measure of migraine impact on daily life.

– 75.8% experiencing pain relief within 2 hours of treatment.

– 37.3% reporting complete pain freedom after using Nerivio.

Opening Doors for Patients

Highmark’s decision opens doors for millions of individuals covered by the company and its affiliates across Pennsylvania, Delaware, New York, and West Virginia. They will now have access to a clinically proven, non-invasive solution for managing both acute and preventive migraine attacks.

“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,” said Alon Ironi, CEO and co-founder of Theranica.

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