Wearable Device for Migraine Treatment Receives Commercial Coverage in the United States

Theranica (Bridgewater, NJ) announced that Highmark Inc. approved commercial coverage for Theranica’s Nerivio Remote Electrical Neuromodulation (REN) wearable device for the acute and preventive treatment of migraine in those aged 12 years and older. Nerivio is the first non-pharmacological migraine treatment option to receive commercial coverage in the United States. Approval was based on the successful completion of Highmark's Coverage with Evidence Development (CED) program to assess Nerivio's clinical benefits.

The CED study was launched in November 2022 and included 384 individuals living with migraine. Study results demonstrated the following: 

• A reduction in the Migraine Disability Assessment Score (MIDAS) from 64.0 to 43.9 points (P<.005)
• 75.8% of participants experienced pain relief within 2 hours post-treatment.
• 37.3% reported pain freedom, 69.0% indicated functional disability relief, and 52.4% specified a full return to functional ability post 2 hours treatment.

"Americans with chronic conditions like migraine have faced a longstanding need for insurance coverage of neuromodulation devices and other non-pharmacological treatments…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,” said Christopher Gottschalk, MD, FAHS, Neurology Division Chief and Director of the Headache and Facial Pain Center at Yale University and the President of the Alliance for Headache Disorders Advocacy (AHDA).