Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 136

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 136
---
 onsite inspections to verify GMP compliance. Failure to maintain and document GMP compliance could result in withdrawal of marketing authorization. In addition changes to manufacturing or testing procedures for the product require approval of the change in the United States prior to the submission of the variation to the registration in the international market. These changes may require approval in each market in order to maintain product distribution. Furthermore, any changes in the distributors supporting our export business could result in a loss of sales.
Pharmaceutical Pricing and Reimbursement
In the United States and other countries, sales of our products depend, in material respects, on the availability of reimbursement from third-party payors. Third-party payors include government health programs, managed care providers, private health insurers and other organizations. These third-party payors are increasingly challenging the prices and examining the cost-effectiveness of medical products and services. In addition, significant uncertainty exists as to the reimbursement status of healthcare products newly approved by regulatory authorities. For example, third-party payors may deny reimbursement if they do not consider the products to be cost-effective as compared to available alternative products. 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 product development.
United States Pharmaceutical Pricing and Reimbursement
In the United States, our products are reimbursed or purchased under several government programs, including Medicaid, Medicare (Parts B and D) and the 340B Program. Medicaid is a joint state and federal government health plan that provides covered outpatient prescription drugs for low income individuals. Medicare is a federally run program that provides healthcare to persons aged 65 and over, as well as certain persons of any age with certain disabilities. The 340B Program is a U.S. federal government drug pricing program under the PHS Act. The availability of federal funds to pay for our products under the Medicaid and Medicare Part B programs requires that we extend discounts under the 340B Program.

89

Medicaid, the 340B Program and the Department of Veterans Affairs.
Medicaid includes a variety of reimbursement programs that differ state by state and imposes reimbursement requirements applicable to both fee-for-service and managed care arrangements. These requirements are applicable to certain of our products. Under Medicaid, drug manufacturers pay rebates to the states based on utilization data provided by the states and pricing information provided by manufacturers, such as AMP (average manufacturer price) and the lowest price available from the manufacturer during the rebate period to any entity in the United States in any pricing structure in the same quarter for which