Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 139

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 139
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 after one to two failed trials of psychopharmacologic agents (such as antidepressant medications)
and subject to the satisfaction of other clinical criteria. Typically, payors (including Medicare) will provide reimbursement for up to
36 treatment sessions of Deep TMS for MDD, although the maximum number of covered sessions varies by insurer and/or location.

  80  

Recently, United HealthCare has updated their Medicare
Advantage policy in states covered by National Government Services Medicare to allow non-physician practitioners, like nurse practitioners,
to order and administer TMS Therapy to their patients with MDD in states where they have scope of practice to do so. Similarly, Aetna
nationwide commercial plans (with 16.8 million covered lives), recently allowed TMS treatment to be ordered and administered by behavioral
health nurse practitioners for patients with MDD, and has removed the previously required four-month psychotherapy trial before a patient
becomes eligible to receive an initial course of treatment with TMS. BlueCross BlueShield of Michigan (with 4.7 million covered lives)
and BlueCross BlueShield of Louisiana (with 1.1 million covered lives) have also issued healthcare policies updates reducing the number
of failed medication trails from four down to two prior to TMS treatment eligibility.

In recent years there has been emerging reimbursement
coverage for Deep TMS for the treatment of OCD, with over 90 million covered lives eligible for coverage as of March 2025. Positive coverage
decisions for Deep TMS for OCD have been issued by Centene Corporation (with 26 million covered lives), Health Care Service Corporation
(HCSC) (with 17 million covered lives), TriCare (with 9.6 million covered lives), Cigna Corporation (with 17 million covered lives), Highmark
(with 6.8 million covered lives), Premera (with 2.6 million covered lives) and LifeWise (with 2.2 million covered lives). Additionally,
one of the seven Medicare Administrative Contractors (MACs) in the US, Palmetto GBA, published a final Local Coverage Determination (LCD)
in 2022 extending coverage applicable to Deep TMS for OCD. While the criteria for this emerging Deep TMS for OCD coverage varies with
each payor, generally, coverage requires the failure of between two and four medication trials before qualifying for reimbursement. Our
strategy is to look for ways to facilitate increased coverage for OCD treatment by more payors, including both commercial and