Expected Impact:
The action under this topic is expected to achieve the following impacts:
- Improved access to innovations that meet the increasingly diverse needs of patients and those of the healthcare systems.
- Better informed decision-making at different levels of the healthcare system (authorities, organisations) using RWD/RWE that will in turn contribute to a better allocation of resources towards cost-effective innovations as well as representation of different patient populations and needs.
- Faster entry to the market of cost-effective medicinal products and devices (including combinations) developed by industry or public not-for-profit developers, which could translate to a positive effect on their R&I investments.
- Industry, sponsors, and other stakeholders have access to structured, evidence-based and practical guidance and recommendations on the use of real-world data / real world evidence (RWD/RWE)1 that could be followed to support the development, and regulatory, health technologies assessment (HTA), and payer decision-making of innovative medicines and health technologies with a focus on medicinal products, medical devices, and therapeutic products that combine a medicinal product with a medical device (drug-device combinations).
- Regulators, HTA bodies and payers will receive more structured and consistent RWD/RWE submissions to inform their decision making.
1 Real World Data (RWD) are defined as "routinely collected data relating to a
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