Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 60

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 60
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 CMS Innovation Center continues to test the proposed models
and has started to roll out plans for access model testing of certain product types (e.g., cell and gene therapies) by states and manufacturers.
At the state level, state legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical
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. In December
2020, the U.S. Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit
managers, or PBMs, and other members of the health care and pharmaceutical supply chain, an important decision that may lead to further
and more aggressive efforts by states in this area. Then, in mid-2022, the Federal Trade Commission, or FTC, 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 arrangements. In addition, in the last few years, several states have formed
prescription drug affordability boards, or PDABs, with the authority to implement upper payment limits, or UPLs, on drugs sold in their
respective jurisdictions. There are several pending federal lawsuits challenging the authority of states to impose UPLs, however.

Most recently, in August 2022,
President Biden signed into the law the IRA. Among other things, the IRA has multiple provisions that may impact the prices of drug products
that are both sold into the Medicare program and throughout the United States. Starting in 2023, a manufacturer of a drug or biological
product covered by Medicare Parts B or D must pay a rebate to the federal government if the 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.