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Theranica's FDA-cleared, drug-free migraine device gains expanded access, more than doubling coverage to 80 million Americans as young as 8 years old who are diagnosed with migraine.
Alon Ironi
(Credit: Theranica)
A newly published policy by Anthem Blue Cross Blue Shield has expanded access to Theranica’s Nerivio remote electrical neuromodulation (REN) wearable, an FDA approved nondrug therapy for both acute and preventive treatment of migraine in adults and children aged 8 and older. The coverage policy provides for greater treatment eligibility for 47 million additional insured members who are diagnosed with migraine and meet the policy’s criteria.1
“We were genuinely grateful to see the insurance company recognize the importance of the Nerivio REN wearable for managing migraine. It’s a meaningful validation of the work we’ve been doing to expand access with major insurers,” Alon Ironi, CEO and co-founder of Theranica, told NeurologyLive® in a recent interview. “Most importantly, we’re excited for the individuals and families who now have a drug-free treatment option for both preventive and acute care of migraine. This policy represents real progress in making safe, effective treatment more accessible to those who need it most.”
The company reported in its release that this action by the country's second largest medical insurer more than doubles the number of insured individuals who currently are covered for the Nerivio REN wearable through prescription, increasing from about 30 million to 80 million patients with migraine across 20 states. Theranica also noted that this recent policy coverage decision follows similar actions made by several other health insurers in the past year in the U.S.
“Expanding health coverage for people with migraine is essential to improving both health equity and quality of life. Affordability is often the biggest barrier to accessing effective care, especially for underserved communities. When non-drug, preventive treatments are covered, patients can manage their migraine without the burden of systemic [adverse] effects. That means fewer missed days at work or school and more time fully present with family, friends, and daily life,” Ironi said.
In November 2024, the FDA approved an expanded age indication for the Nerivio REN wearable to treat pediatric patients aged 8 years and older with acute migraine. In February 2023, the company received FDA approval for the Nerivio REN wearable as a dual-use acute and preventive treatment for migraine with or without aura in patients 12 years of age or older. In October 2020, the Nerivio medical device received clearance from the agency for an expansion on its treatment indication to include the acute treatment of chronic migraine in patients aged 18 years and older.
(Credit: Theranica)
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Building on the growing accessibility of Theranica’s Nerivio REN wearable, a recent retrospective study (NCT06180577) published in Children evaluated its real-world use in school settings, finding that it could enable more timely migraine treatment for students aged 7 years to 17 years. The findings reflected a significant improvement in treatment patterns and highlighted the device’s value in overcoming barriers common in school environments.2,3
The study surveyed 332 young REN users, revealing that after being prescribed the wearable, the proportion of students treating migraine at school rose from 78.3% to 89.8%. With most respondents using REN either alone (38.0%) or in combination with medication (27.4%), the results reinforced the device’s appeal as a nondisruptive, drug-free treatment option for young patients.
Students participating in the study cited key barriers to treatment during school hours, including the need to visit the nurse’s office (64.2%) and concerns about standing out among peers (42.2%). Although REN introduced a unique barrier, requiring smartphone use permissions in class (22.9%), its advantages were clear. The most common reasons for preferring REN use at school were avoiding trips to the nurse’s office (42.5%) and being able to treat discreetly (39.2%).
“There are very few preventive and acute treatment options for children and adolescents with migraine. The Nerivio REN wearable is a much-needed, drug-free solution that’s FDA-cleared for individuals as young as 8 years old, offering early intervention that may help prevent migraine chronification into adulthood,” Ironi told NeurologyLive. “However, without insurance coverage, many families simply can’t access it. This policy is a critical step forward, giving families the ability to help their children manage migraine without drugs or systemic side effects, so kids can stay engaged in school, friendships, and everyday life.”