Reflects Broader Trends Significantly Increasing Access to Deep TMS for OCD and Depression Patients
BURLINGTON, Mass. and JERUSALEM, Nov. 03, 2022 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that Premera Blue Cross, an independent licensee of the Blue Cross Blue Shield Association (BCBSA), will extend positive coverage applicable to Deep Transcranial Magnetic Stimulation (Deep TMS™) for the treatment of obsessive-compulsive disorder (OCD) as of February 3, 2023.
Premera provides commercial health coverage to more than 2.6 million people in the Pacific Northwest, from individuals and families in Alaska and Washington to employees of Fortune 100 companies across the country. Premera now joins other payors covering Deep TMS for OCD, including Centene, Cigna, Highmark, Health Care Services Corporation (HCSC), Tricare, and Palmetto GBA Medicare, resulting in approximately 90 million covered lives for this indication. Premera’s policy has also reduced its major depressive disorder (MDD) TMS coverage criteria, now requiring only three failed medication trials instead of four.
“Mental health and behavioral health are of paramount importance in our society, and better access to providers and appropriate levels of care is absolutely critical. The expanded coverage by Premera, for both OCD and depression, will make a tremendous difference in the lives of patients,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “These developments are reflective of the broader trends from both public and private medical insurance that are resulting in broader access to Deep TMS therapy in multiple indications.”
In further support of these expanded access trends, final and draft Local Coverage Determinations, respectively, were recently issued by CGS and NGS, two Medicare Administrative Contractors (MACs), reducing the number of previous medication failures required to qualify for TMS treatment for MDD from four to two. These MACs collectively represent 14.5 million covered lives, and once implemented, the changes will result in all 60+ million Medicare beneficiaries in the country qualifying for Deep TMS depression coverage after either one or two failed medication trials. Private payers including Anthem, Aetna, Cigna, and HCSC likewise now require only two failed medication trials prior to qualifying for Deep TMS coverage for depression.
Furthermore, NGS is now expanding its TMS coverage criteria to include psychiatric nurse practitioners, making it the first MAC to join the commercial payers who have already taken this step, including Magellan, Centene, HCSC, Premera, CareSource, Pacific Source, and SelectHealth/Intermountain Healthcare.
BrainsWay’s patented H-Coil technology was first FDA-cleared for treating depression in 2013 and OCD in 2018, and is designed to penetrate deeper and broader structures of the brain than traditional TMS coils.
BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com.
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements.
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SVP and Chief Financial Officer
Meghan Seale Laska