Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 209

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 209
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, the European Union, and other potentially significant
markets for our product candidate, government authorities and third-party payors are increasingly attempting to limit or regulate the
price of medical products and services, particularly for new and innovative products and therapies, which often has resulted in average
selling prices lower than they would otherwise be. Further, the increased emphasis on managed healthcare in the United States and on country
and regional pricing and reimbursement controls in the United Kingdom and European Union will put additional pressure on product pricing,
reimbursement and usage, which may adversely affect our future product sales and results of operations. These pressures can arise from
rules and practices of managed care groups, judicial decisions and laws and regulations related to Medicare, Medicaid and healthcare reform,
pharmaceutical coverage and reimbursement policies and pricing in general.

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Third-party payors are increasingly
imposing additional requirements and restrictions on coverage and limiting reimbursement levels for medical products. For example, federal
and state governments reimburse covered prescription drugs at varying rates generally below average wholesale price. These restrictions
and limitations influence the purchase of healthcare services and products. Third-party payors may limit coverage to specific drug products
on an approved list, or formulary, which might not include all of the FDA-approved drug products for a particular indication. Third-party
payors are increasingly challenging the price and examining the medical necessity and cost-effectiveness of medical products and services,
in addition to their safety and efficacy. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical
necessity and cost-effectiveness of our products, in addition to the costs required to obtain the FDA approvals. Our product candidate
may not be considered medically necessary or cost-effective. A payor's decision to provide coverage for a drug product does not imply
that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product
does not assure that other payors will also provide coverage for the drug product. Adequate third-party reimbursement may not be available
to enable us to maintain price levels sufficient to realize an appropriate return on our investment in drug development. Legislative proposals
to reform healthcare or reduce costs under government insurance programs may result in lower reimbursement for our products and product
candidate or exclusion of our product candidate from coverage. The cost containment measures that healthcare payors and providers are
instituting and any healthcare reform could significantly reduce our revenues from the sale of any approved product candidates. We cannot
provide any assurances that we will be able to