Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 105

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 105
---
 to allow for discussions on harmonization topics for regulatory authorities. Some agreements, such as the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), are international in nature, while others are between specific countries. The requirements of many countries (including Japan and several EU Member States) to negotiate selling prices or reimbursement rates for pharmaceutical products with government regulators significantly extend the time to market entry beyond the initial marketing approval. While marketing authorizations for new pharmaceutical products in the EU have been largely centralized within the EC in collaboration with the EMA, pricing and reimbursement remain a matter of national competence. For a description of risks relating to the regulatory environment in which we operate, refer to “— Item 3.D. Risk Factors — Product liability claims could adversely affect our business, results of operations and financial condition.”

| SANOFIFORM 20-F2024 | 43 |

| PART I                             |
| ITEM 4. Information on the Company |

B.5.4. Pricing & reimbursement We are operating in a highly volatile and competitive market access and launch environment globally. Faced with mounting budget pressure, governments and payers are using several drug price control policies such as price referencing for imported drugs, increased patient co-payments, restrictive formularies, prescribing guidelines, tendering procedures, generic and biosimilar substitution, and medico-economic evaluations of healthcare products. In addition, the industry faces growing pressure to demonstrate the value and cost-effectiveness of products throughout their life cycle (e.g. comparative efficacy studies, real-world patient data, budget modelling) to meet diverse and stringent payer evidence requirements , raising the bar for market entry in many countries. Despite numerous pricing and reimbursement challenges, payers and regulators remain committed to providing access to new innovative therapies , with greater emphasis on real-world evidence (RWE). These trends are likely to continue in the coming year amid economic, political and geopolitical headwinds . United States The US health insurance system is comprised of commercial insurance and government-provided insurance. Commercial insurance is offered widely as part of employee benefit packages and is the main source of employee access to subsidized healthcare. Some individuals purchase private health plans directly or through marketplaces established under the Affordable Care Act, while publicly subsidized programs provide coverage for retirees, the indigent, the disabled, uninsured children, and active or retired military personnel. Double coverage can occur. Commercial insurance includes: • Managed Care Organizations (MCOs), which combine the functions of health insurance, delivery of care, and administration. MCOs use specific provider networks and specific services