BrainsWay Secures Major Insurance Coverage Expansions for Deep TMS Therapy in Adolescent Depression
核心洞察
Premera Blue Cross Blue Shield (搜索) becomes the first payer to formally adopt coverage for BrainsWay's accelerated SWIFT (搜索) Deep TMS (搜索) protocol for patients ages 15 and older with moderate to severe major depressive disorder (搜索).
Optum Behavioral Health (搜索) expands its medical policy to cover Deep TMS (搜索) therapy for adolescents aged 15 and older, representing more than 48 million covered lives in one of BrainsWay's most significant single-policy expansions.
The coverage expansions collectively bring BrainsWay's total covered lives to approximately 180 million across multiple major insurers, addressing an estimated 5 million adolescents aged 15-21 affected by major depression (搜索) in the United States.
BrainsWay Ltd. (NASDAQ & TASE: BWAY) has achieved significant milestones in expanding insurance coverage for its Deep TMS (搜索) therapy, with two major payers adopting new policies that broaden access to the company's noninvasive brain (搜索) stimulation treatment for adolescent depression (搜索).
First Coverage for Accelerated SWIFT Protocol
Premera Blue Cross Blue Shield (搜索), serving over 2.8 million covered lives across Alaska and Washington state, has become the first payer to formally adopt a medical policy covering BrainsWay's accelerated SWIFT (搜索) (Short-course with Intrinsic Field Targeting) Deep TMS (搜索) protocol. The new policy expands coverage to include patients ages 15 and older with moderate to severe major depressive disorder (搜索).
"We are elated at Premera's decision to formally adopt a policy covering our SWIFT (搜索) depression (搜索) protocol, which marks a first among payers. SWIFT entails significantly fewer days spent in the clinic, allowing patients to achieve meaningful improvement more quickly than our standard Deep TMS (搜索) protocol," stated Hadar Levy, Chief Executive Officer of BrainsWay.
The SWIFT (搜索) depression (搜索) protocol consists of an acute phase of five treatment sessions (ten minutes each) per day for six days, followed by two sessions per day once a week for four weeks, for a total of 38 sessions. The protocol requires no functional MRI or other expensive neuronavigational equipment.
Optum Expands Coverage to 48 Million Lives
In a separate development, Optum Behavioral Health (搜索), part of UnitedHealth Group, has expanded its medical policy to cover Deep TMS (搜索) therapy for adolescents aged 15 and older diagnosed with major depressive disorder (搜索). Optum's network represents more than 48 million covered lives, making this one of the most meaningful single-policy expansions for BrainsWay to date.
The decision reflects growing payer confidence in Deep TMS (搜索) as a clinically proven, non-drug treatment option, particularly for younger patients who do not respond to or cannot tolerate traditional antidepressant medications.
Growing Payer Network
Optum now joins an expanding list of insurers covering Deep TMS (搜索) for adolescent depression (搜索), including Evernorth Health Services, CVS/Aetna, Medi-Cal, PacificSource Health Plans, TRICARE, and several Blue Cross and Blue Shield organizations such as Health Care Service Corporation, Highmark, Regence, Florida Blue, Blue Cross Blue Shield of Michigan and Blue Cross Blue Shield of North Carolina.
Collectively, these payers cover roughly 180 million lives. The expansion is particularly notable given the estimated 5 million adolescents aged 15-21 in the United States affected by major depression (搜索), a population with limited effective treatment options.
Clinical Evidence and Market Response
"BrainsWay's clinical trial and real-world evidence demonstrates comparable response and remission outcomes for its SWIFT (搜索) accelerated depression (搜索) protocol when compared to the standard Deep TMS (搜索) protocol. We are committed to continuing our efforts to educate stakeholders within our space on the compelling data supporting additional favorable coverage of this novel protocol," stated Colleen Hanlon, PhD, Vice President of Medical Affairs for BrainsWay.
Following the Optum announcement, BrainsWay shares gained 10.1% at market closing. The stock has climbed 53.6% over the past six months, significantly outperforming the industry's 5.5% growth and the S&P 500's 15.1% gain during the same period.
Technology and Treatment Approach
Deep TMS (搜索) is a noninvasive brain (搜索) stimulation therapy that uses BrainsWay's patented H-coil technology to stimulate deeper and broader regions of the brain associated with mood regulation. FDA-cleared for depression (搜索), including as an adjunctive treatment for adolescents, Deep TMS delivers magnetic pulses without surgery or systemic drug exposure, offering a well-tolerated option for patients who do not respond adequately to antidepressant medications.
BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies. Current indications include major depressive disorder (搜索) (including reduction of anxiety symptoms, commonly referred to as anxious depression (搜索)), obsessive-compulsive disorder (搜索), and smoking addiction (搜索).
Market Outlook
The global neuromodulation devices market was estimated at $5.80 billion in 2024 and is projected to reach $10.39 billion by 2030, registering a compound annual growth rate of 8.51% from 2025 to 2030. The increasing incidence of chronic pain, neurological disorders and mental health conditions is expected to drive demand for effective and innovative treatment solutions.
BrainsWay currently has a market capitalization of $334.8 million and projects an earnings growth of 100% for the current year. The company continues to advance its clinical pipeline, recently launching a multicenter clinical trial evaluating its next-generation Deep TMS (搜索) 360 system for the treatment of Alcohol Use Disorder (搜索).