BrainsWay announced today that Cigna is offering positive coverage for its neurostimulation treatment of obsessive-compulsive disorder (OCD).
Cigna provides commercial health coverage to approximately 17 million members in 13 states. It has Medicare Advantage plans in 16 states and is part of the Health Insurance Marketplace online 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 patented H7 coil is designed to penetrate deeper and broader structures of the brain associated with OCD.
BrainsWay’s deep TMS system received FDA de novo clearance for treating OCD in 2018. The company launched it in a full-market release in 2019. As of June 30, 2022, it shipped 368 OCD coils as add-on helmets to accompany BrainsWay platform systems. The company said approximately 45% of BrainsWay systems in the field include 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,” said Christopher von Jako, president and CEO of 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.”
How the coverage applies
Cigna will issue an updated revision to its TMS medical coverage policy, effective Sept. 15, 2022. It extends coverage to patients 18 and older diagnosed with OCD.
Under the revised policy, an initial 30-36 TMS treatment session regimen will be classified as medically necessary after a failure of two or more medication trials and a trial of evidence-based psychotherapy without significant improvement in symptoms. Patients with 30% of greater improvement on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) maintained for at least two months would also be candidates for an additional regimen of 30-36 sessions.
“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,” said Dr. Aron Tendler, CMO of BrainsWay. “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.”