Highmark Blue Cross Blue Shield released a draft medical policy on January 21, 2026 that expands coverage to adolescent and adult patients with major depressive disorder treated with BrainsWay’s accelerated SWIFT™ Deep TMS protocol. The policy would cover the 38‑session course: five daily sessions for six days, followed by two weekly sessions for four weeks.
The policy follows FDA clearance of the accelerated protocol in September 2025 and builds on robust clinical evidence. A multisite randomized trial reported an 87.8% response rate and 78.0% remission rate, and the protocol does not require functional MRI or other expensive neuronavigational equipment, making it more accessible for clinics.
BrainsWay’s financial performance in the first half of 2025 supports the commercial potential of the expanded coverage. Q2 2025 revenue rose 26% to $12.6 million, gross margin climbed to 75%, and net profit increased 233%. The company also reported $62 million in remaining performance obligations as of June 30, 2025, indicating strong pipeline demand.
The draft policy is expected to take effect in February 2026 after an open comment period. BrainsWay’s Director of Market Access, Scott Blackman, said the coverage expansion, together with a similar policy adopted by another payer, signals a growing trend in reimbursement for accelerated Deep TMS and will broaden patient access to a treatment that requires fewer clinic visits.
Historically, coverage expansions for BrainsWay’s accelerated Deep TMS have been well received by investors, with prior announcements of adolescent coverage and accelerated protocol coverage generating positive market reactions. The new policy is likely to reinforce confidence in BrainsWay’s market position and could accelerate adoption across the U.S. payer landscape.
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