Theranica’s Nerivio wearable migraine therapy is now covered by health insurance for 158 million Americans following a series of US payer expansions.

Theranica has announced that its FDA-cleared wearable migraine therapy Nerivio is now covered by health insurance for 158 million people across the USA, following a series of reimbursement expansions that bring the device to more than half of the country’s insured population.

The milestone follows new agreements with a nationwide health insurer and additional coverage policies introduced across several states. According to the company, insurance coverage for Nerivio has doubled over the past 15 months, making it one of the fastest reimbursement expansions reported for a prescribed therapeutic device.

Nerivio uses Remote Electrical Neuromodulation (REN) technology and is cleared by FDA for both the acute and preventive treatment of migraine. The wearable device provides a non-drug treatment option for people living with the neurological condition.

Theranica said commercial insurance coverage for Nerivio is now comparable with leading branded prescription migraine medicines, with reimbursement available through a combination of national and regional health plans.

For the estimated 39 million Americans living with migraine, broader insurance coverage could improve access to non-pharmacological treatment options by reducing financial barriers to care.

Alon Ironi, chief executive officer and co-founder of Theranica, said: “This expanded access to Nerivio represents a historical paradigm shift in the U.S. healthcare system, finally recognizing that evidence-based, non-drug treatments can be a vital part of medical care. With more than one out of every two Americans now having covered access to this therapy, clinicians who treat people with migraine can make purely clinical, patient-centric treatment decisions, without having to worry about the economic burden on their patients.”

Migraine is one of the most common neurological disorders worldwide and can have a significant impact on quality of life. While medicines remain the mainstay of treatment for many patients, there is increasing interest in non-drug approaches, particularly for people who cannot tolerate or do not respond adequately to pharmacological therapies.

The company said Nerivio is currently the only FDA-cleared non-drug migraine treatment to achieve this level of commercial insurance coverage outside the Veterans Health Administration.

Noah Rosen, director of the headache center at Northwell Health, said: “Insurance coverage remains one of the most important factors influencing patient access to migraine care. It is critical that insurance companies expand the range of options for clinicians and patients dealing with this debilitating, chronic neurological disorder by adding evidence-based, FDA-cleared therapies to their formularies. Broader reimbursement helps ensure treatment decisions are guided by clinical need rather than coverage limitations.”

Theranica also said patients whose health plans do not yet cover Nerivio may be eligible for a patient assistance programme while reimbursement continues to expand.