Company: BLRX
Filing Date: 2025-03-31
Form Type: 20-F
Source: 0001178913-25-001123
Chunk: 106

Company: BioLineRx Ltd.
Filing Date: 2025-03-31
Form: 20-F
Item: Item 3
Chunk 106
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 a drug or biological product covered by Medicare
Parts B or D must pay a rebate to the federal government if the drug product’s price increases faster than the rate of inflation.
This calculation is made on a drug product by drug product basis and the amount of the rebate owed to the federal government is directly
dependent on the volume of a drug product that is paid for by Medicare Parts B or D. Additionally, starting in payment year 2026, CMS
will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition. CMS will
also negotiate drug prices for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for
negotiation, it is expected that the revenue generated from such drug will decrease. CMS has begun to implement these new authorities
and entered into the first set of agreements with pharmaceutical manufacturers to conduct price negotiations in October 2023. However,
the IRA’s impact on the pharmaceutical industry in the United States remains uncertain, in part because multiple large pharmaceutical
companies and other stakeholders (e. g., the U. S. Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program
is unconstitutional for a variety of reasons, among other complaints. Those lawsuits are currently ongoing.

To date, President Trump has signed an Executive Order to require
drug prices to be transparent. In addition, the President reversed certain policies by the Biden Administration. President Trump eliminated:
Medicare $2 drug list model, cell and gene therapy access model to improve high-cost drugs for Medicaid enrollees, and accelerate clinical
evidence model for new drug. It is not clear what additional changes may be implemented, but President Trump does want disclosure of transparency
in prices.

Individual states in the United States have also increasingly passed legislation and
implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts,
restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage
importation from other countries and bulk purchasing. For example, in recent years, several states have formed prescription drug affordability
boards (PDABs). Much like the IRA’s drug price negotiation program, these PDABs have attempted to implement upper payment limits
(UPLs) on drugs sold in their respective states in both public and commercial health plans. In August 2023, Colorado’s PDAB announced
a list of five prescription drugs that would undergo an affordability review. The effects