Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 211

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 211
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. 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.

At the state level in the
United States, legislatures 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 PDABs. Much like the IRA’s drug price negotiation program, these PDABs have attempted
to implement 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 of these efforts remain uncertain
pending the outcomes of several federal lawsuits challenging state authority to regulate prescription drug payment limits. Furthermore,
in December 2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical
benefit managers and other members of the healthcare and pharmaceutical supply chain, an important decision that may lead to further and
more aggressive efforts by states in this area. The Federal Trade Commission in mid-2022 also launched sweeping investigations into the
practices of the PBM industry that could lead to additional federal and state legislative or regulatory proposals targeting such entities’
operations, pharmacy networks, or financial