Reflects broader trends dramatically increasing access to deep TMS for patients with OCD and depression
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 Blue Cross Blue Shield Association (BCBSA), will expand 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 medical 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 payers covering Deep TMS for OCD, including Centene, Cigna, Highmark, Health Care Services Corporation (HCSC), Tricare and Palmetto GBA Medicare, representing approximately 90 million covered lives for this indication. Premera’s policy also reduced its criteria for TMS coverage for major depressive disorder (MDD), now requiring only three failed drug trials instead of four.
“Mental health and behavioral health are of paramount importance in our society, and better access to appropriate providers and levels of care is absolutely essential. Premera’s expanded coverage for both OCD and depression will make a huge difference in patients’ lives,” said Christopher von Jako, Ph.D., President and CEO of BrainsWay. “These developments reflect broader trends in public and private medical insurance that are resulting in broader access to Deep TMS therapy in multiple indications.”
To further support these expanded access trends, final and preliminary local coverage determinations, respectively, were recently released by CGS and NGS, two Medicare Administrative Contractors (MACs), reducing the number of prior medication failures. needed to qualify for TMS treatment for MDD of four to two. These MACs collectively represent 14.5 million lives covered, and once implemented, the changes will allow more than 60 million Medicare beneficiaries nationwide to qualify for Deep TMS depression coverage after one or two tries. failed drugs. Similarly, private payers including Anthem, Aetna, Cigna and HCSC now only need two failed drug trials before qualifying for Deep TMS coverage for depression.
Additionally, NGS is now expanding its TMS coverage criteria to include Psychiatric Nurse Practitioners, making it the first MAC to join 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 approved by the FDA for the treatment of depression in 2013 and OCD in 2018, and is designed to penetrate deeper and wider brain structures than traditional TMS coils .
BrainsWay is a world leader in advanced non-invasive 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-approved indications supported by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxiety depression), obsessive-compulsive disorder, and tobacco addiction. The company is committed 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 addictive disorders are ongoing. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness and access to Deep TMS. For the latest news and information on BrainsWay, please visit www.brainsway.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be prefaced by the words “intends”, “may”, “will”, “expects”, “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 Company’s management 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. . Further, historical results or the conclusions of 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 in the same way light of further research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: insufficient financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in initiating and/or completing planned clinical studies and trials; failure to obtain regulatory approvals within the Company’s timelines, or at all; failure 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 failure to develop necessary improvements; 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 applicable laws and rules and regulations; adverse market perception and acceptance of Deep TMS technology; insufficiency or delays in reimbursement by third-party payers, including insurance companies and Medicare; inability to market Deep TMS, including internationally, by the Company or through third-party distributors; development of products by competitors; failure to develop and introduce new technologies, products and applications on a timely basis, which could cause the Company’s actual results or performance to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statements in this press release speak only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by applicable securities laws. More detailed information about the risks and uncertainties affecting the Company can be found under the heading “Risk Factors” in the Company’s filings with the United States Securities and Exchange Commission.
SVP and CFO
Meghan Seale Laska