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Nerivio, a smartphone-controlled therapeutic wearable made by Theranica, became first non-pharmacological migraine treatment in the U.S. to receive commercial coverage policy.

In a Feb. 20 press release, Theranica announced its neuromodulation device is now included under a policy by Highmark Inc. The Pittsburgh-based insurance carrier covers 7 million people in Delaware, New York, Pennsylvania and West Virginia.

According to Theranica, an Israeli biotech with a U.S. site in Bridgewater, the coverage decision stems from the results of a study of 384 Highmark migraine sufferers.

Results showed:

• 75% experienced pain relief within two hours of treatment, 37.3% reporting pain freedom and 69% indicating significant relief
• 52.4% said they made a full return to functional ability in the two hours after using the armband treatment

Commenting on the decision, Theranica co-founder and CEO Alon Ironi said it advances accessibility of effective, drug-free treatment for the 1 billion people worldwide who suffer from the debilitating neurological condition.

“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,” Ironi said.

“Highmark broke that barrier with a scientific approach: they initiated a carefully planned [Coverage with Evidence Development] 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,” he said.

The U.S. Food and Drug Administration initially approved a prescription-only treatment in 2020 for acute therapy. Last year, it was authorized as a preventative treatment for ages 12 and up.

Controlled by a smartphone app and self-administered, Nerivio is a complete migraine care treatment. The device wraps around the upper arm and uses 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). That turns off migraine pain and associated symptoms without medication.

Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment, according to Theranica.

The list price is $599 for a 12-treatment unit. Under the Nerivio Direct Savings Program, the first device is available for $10 to anyone with commercial insurance. Nerivio is also covered by United States Veterans Administration (VA) system health insurance.