Cigna® Issues Favorable Policy for Deep TMS for Treatment of Drug-Resistant OCD
Burlington, MA and Jerusalem, Israel, September 14, 2022 (GLOBE NEWSWIRE) – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation therapies Cigna Corporation today announced Cigna’s announcement of positive coverage of deep transcranial magnetic stimulation (TMS) for the treatment of obsessive-compulsive disorder compulsive disorder (OCD). Cigna, one of the largest medical insurance companies in the United States, provides commercial health coverage to nearly 17 million members in 13 states, has Medicare Advantage plans in 16 states, and participates in the health insurance market.© Online exchange. With this new policy, Cigna joins the ranks of Centene, Highmark, Health Care Services Corporation, Blue Cross Blue Shield, Tricare and Palmetto GBA Medicare, resulting in more than 86 million adults gaining access to BrainsWay’s groundbreaking Deep TMS™ OCD treatment.
“Creating this positive OCD coverage also facilitates BrainsWay’s ability to leverage its leadership role in advancing treatment for this debilitating condition,” said Christopher von Jako, PhD, president and CEO of BrainsWay. “Importantly, the ongoing reimbursement momentum of deep TMS is leading to increased access to our unique treatment that is critical to our mission to improve health and transform the lives of those with disorders with limited treatment options.”
Cigna will issue an updated revision of its TMS coverage policy effective September 15, 2022 to extend coverage to patients 18 years of age or older who have been diagnosed with OCD. Under the revised policy, a 30-36 TMS initial therapy session regimen will be categorized as medically necessary after two or more drug trials and an evidence-based psychotherapy trial have failed without significant improvement in symptoms. Patients who have experienced a 30% or greater improvement in their Yale-Brown OCD scale (Y-BOCS) for at least 2 months will also be candidates for an additional 30-36 session regimen.
“This achievement is further acknowledgment of the significant efforts contributed by the lead investigators in the pilot and pivotal trials of Deep TMS, clinicians in the field who treat today OCD patients, and BrainsWay partners dedicated to expanding access and awareness of this life-changing experience,” said Aaron Tendler, MD, chief executive officer. Clinicians at BrainsWay.” OCD is a difficult disease to treat, and nearly half of OCD patients resist treatment. BrainsWay continues to lead in this field, and remains the only TMS company to demonstrate clinical efficacy in the treatment of OCD with randomized, placebo-controlled data.”
BrainsWay’s patented H7 Coil is designed to penetrate the deeper and broader structures of the brain associated with OCD. The company’s Deep TMS system was granted De Novo clearance by the US Food and Drug Administration (FDA) for the treatment of OCD in late 2018 and has been fully released to the market in 2019. As of June 30, 2022, 368 OCD files have been shipped as additional helmets to accompany BrainsWay Platform Systems. Approximately 45% of all BrainsWay systems in this area have an H7 coil.
“The economic burden on the US healthcare system for OCD treatments is over $10.6 billion annually, and we are excited that Cigna’s leadership in medical and behavioral health has recognized the value we can provide to these patients,” said Scott Blackman, director of market access at Cigna. . minds way. “This positive coverage decision complements the growing body of compelling clinical evidence supporting the treatment of OCD with our Deep TMS H7 profile.”
About obsessive-compulsive disorder
Obsessive-compulsive disorder (OCD) is a chronic and debilitating condition with a lifetime prevalence in the United States of 2.3%. Obsessive-compulsive disorder is characterized by recurring, uncontrollable thoughts (obsessions) and behaviors (compulsions) that the patient feels compelled to repeat over and over, and is considered one of the top 10 debilitating medical conditions associated with decreased quality of life and loss of income by the World Health Organization (WHO). Due to the complexity and heterogeneity of the condition, along with the high percentage of drug-resistant patients, many patients with OCD do not respond well to first treatment options. The economic burden on the US health care system for OCD treatments is estimated to be more than $10.6 billion annually.
BrainsWay is a global leader in advanced noninvasive neurostimulation therapies for mental health disorders. The company is boldly advancing neuroscience with its Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS to have three FDA approved indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reducing anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The company is dedicated to leadership through superior science and building on an unparalleled body of clinical evidence. Additional clinical trials of deep TMS are underway in various psychiatric, neurological, and addiction disorders. Founded in 2003, with offices in Burlington, Massachusetts and Jerusalem, Israel, BrainsWay is committed to increasing the global awareness and broad reach of Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
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