Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 27

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 27
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. Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s
determination that the use of an approved product is:

  a covered benefit under its health plan;  

  safe, effective and medically necessary;  

  appropriate for the specific patient;  

  cost-effective; and  

  neither experimental nor investigational.  

Obtaining reimbursement approval for a product from each government
or other third-party payor is a time-consuming and costly process that could require us or our licensees to provide supporting scientific,
clinical and cost-effectiveness data for the use of our products to each payor. Even when a payor determines that a product is eligible
for reimbursement, the payor may impose coverage limitations that preclude payment for some uses that are approved by the FDA or comparable
foreign regulatory authorities. Reimbursement rates may vary according to the use of the product and the clinical setting in which it
is used, may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments
for other products or services, and may reflect budgetary constraints and/or imperfections in Medicare, Medicaid or other data used to
calculate these rates.

17

Regardless of the impact of the ACA on us, the U. S. government,
other governments and commercial payors have shown significant interest in pursuing healthcare reform and reducing healthcare costs. Any
government-adopted reform measures could cause significant pressure on the pricing of healthcare products and services, including those
biopharmaceuticals currently being developed by us or our licensees, in the United States and internationally, as well as the amount of
reimbursement available from governmental agencies or other third-party payors. The continuing efforts of the U. S. and foreign governments,
insurance companies, managed care organizations and other payors to contain or reduce healthcare costs may compromise our ability to set
prices at commercially attractive levels for our products that we may develop, which in turn could adversely impact how much or under
what circumstances healthcare providers will prescribe or administer our products, if approved. Changes in healthcare policy, such as
the creation of broad limits for diagnostic products, could substantially diminish the sale of or inhibit the utilization of diagnostic
tests, increase costs, divert management’s attention and adversely affect our ability to generate revenues and achieve consistent
profitability. This could materially and adversely impact our business by reducing our ability to generate revenue, raise capital, obtain
additional collaborators and market our products