Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 19

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 19
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Obtaining adequate reimbursement of Deep TMS for
smoking addiction, or for any future indications or expanded labeling of currently approved indications or different treatment protocols,
as applicable, may be difficult unless there is sufficient published clinical data to support clinical efficacy and cost effectiveness
based upon the treatment continuum of care. Currently, there is no third-party coverage of Deep TMS as a treatment for smoking addiction,
as payors that have evaluated Deep TMS for smoking addiction coverage have not yet concluded that it is a reasonable and necessary therapy
for smoking addiction. In October 2023 the Clinical TMS Society, an influential peer group, published the first coverage recommendations
for smoking. While this is an important first step toward educating payors, ongoing efforts advocating for coverage will be required,
which may be expensive and time-consuming. Therefore, it may take significant time to obtain sufficient reimbursement coverage of Deep
TMS for smoking addiction. We may be required to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the
level of reimbursement compared to existing approved biologics and other therapies. There may be significant delays in obtaining coverage
and reimbursement for newly approved therapies in the United States, and coverage may be more limited than the indications for which the
product is approved by the FDA or similar regulatory authorities outside the United States. Further, there is no guarantee that Deep TMS
will ever be adequately covered or reimbursed for smoking addiction, if at all, or any other future indication for which we obtain authorization,
if any. Nonetheless, the availability of reimbursement coverage in any given indication is not always the exclusive path to commercialization,
and we may pursue and/or develop cash-pay, corporate wellness programs, and/or other alternate models in order to monetize these indications.

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In addition, the U. S. federal government and state
legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement.
To contain costs, governmental healthcare programs and third-party payors are increasingly challenging the price, scrutinizing the medical
necessity, and reviewing the cost-effectiveness of medical treatments. Outside of the United States, reimbursement systems vary significantly
by country. Many foreign markets have government-managed healthcare systems that govern reimbursement for psychiatric treatments and procedures
and certain markets, including Japan, impose additional criteria that must be met (such as the need for approval by sometimes insular
medical societies) before coverage may be practically obtained even on approved procedures. Additionally, some foreign reimbursement systems
provide for