Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 62

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 62
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 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. Any additional federal
or state healthcare reform measures could limit the amounts that third-party payers will pay for future healthcare products and services,
and, in turn, could significantly reduce the projected value of certain development projects and reduce our profitability.

Outside of the United States,
particularly in the European Union, the coverage status and pricing of prescription pharmaceuticals and biologics is subject to governmental
control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing
approval for a product. Furthermore, the requirements may differ across the E.U. Member States. To obtain coverage and reimbursement or
pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product
candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is
set at unsatisfactory levels, our business could be harmed