Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 207

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 207
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 any of which could adversely affect a pharmaceutical manufacturer’s ability to operate its business and the results of its operations.

Coverage and Reimbursement

The future commercial success
of our product candidate or any of our collaborators' ability to commercialize any approved product candidate successfully will depend
in part on the extent to which governmental payor programs at the federal and state levels, including Medicare and Medicaid, private health
insurers and other third-party payors provide coverage for and establish adequate reimbursement levels for our product candidate. Government
health administration authorities, private health insurers and other organizations generally decide which drugs they will pay for and
establish reimbursement levels for healthcare. In particular, in the United States, private health insurers and other third-party payors
often provide reimbursement for products and services based on the level at which the government, through the Medicare or Medicaid programs,
provides reimbursement for such treatments. In the United States, the United Kingdom, 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