BrainsWay scores coverage win on neurostim treatment for OCD

BrainsWay today announced Cigna’s positive coverage for the neurostimulation treatment obsessive-compulsive disorders (OCD).

Cigna offers commercial health coverage to around 17 million members in 13 US states. It offers Medicare Advantage plans to 16 states and is part on the Health Insurance Marketplace website exchange. It joins Centene, Highmark, Health Care Services Corporation, Blue Cross Blue Shield, Tricare, and Palmetto GBA Medicare as those offering coverage to BrainsWay’s treatment.

The coverage decision is applicable to BrainsWay’s proprietary deep transcranial magnetic stimulation (TMS) for treating OCD. Its H7 coil, a patent invention, penetrates deeper and more complex structures of the brain that are associated with OCD.

BrainsWay’s deep TMS system received FDA de novo clearance for treating OCD in 2018. It was released in full-market in 2019. It shipped 368 OCD coils in add-on helmets for BrainsWay platform system systems as of June 30, 2022. According to the company, about 45% of BrainsWay systems on the field contain an H7 coil.

“The establishment of this positive coverage for OCD further facilitates BrainsWay’s ability to capitalize on its leadership role in advancing treatment of this debilitating condition,” Christopher von Jako is the president and CEO at BrainsWay. “More importantly, the continued reimbursement momentum for deep TMS is resulting in increased access of our unique therapy that is critical to our mission of improving the health and transforming the lives of those suffering from disorders with limited treatment options.”

What coverage is available

Cigna will announce a revised revision to its TMS medical policy policy, effective September 15, 2022. It extends coverage to OCD patients 18 years and older.

The revised policy will allow for a 30-36 TMS treatment regimen to be considered medically necessary following failure of at least two or more medication trials. Also, a trial of evidence-based psychological therapy without significant improvement in symptoms will be allowed. Patients who have experienced a 30% improvement on the Yale Brown Obsessive Compulsive Score (Y-BOCS), for at least two consecutive months, would be eligible for an additional 30-36 session regimen.

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“This achievement is a further acknowledgment of the substantial efforts contributed by the principal investigators in the pilot and pivotal trials of deep TMS, the clinicians in the field today treating OCD patients, and BrainsWay’s partners dedicated to expanding access and awareness to this life-changing treatment,”Dr. Aron Tendler, CMO at BrainsWay, said: “OCD is a difficult to treat disease, and almost half of the patients with OCD are treatment-resistant. BrainsWay continues to be a trailblazer in the field, and remains the only TMS company to have demonstrated clinical efficacy in treating OCD through randomized, placebo-controlled data.”

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