Last month, the U.S. Food and Drug Administration (FDA) released its framework for evaluating the potential use of real-world evidence (RWE) to help support the approval of a new indication for a pre-approved medicine and satisfy post-approval study requirements.
Development of the framework was required under the 21st Century Cures Act and is a first step toward meeting those requirements. But how is RWE really being used and how will the FDA framework likely to affect decision-makers beyond the FDA?
This webinar will showcase the potential implications of the FDA framework for patients, payers, manufacturers and other health care stakeholders, including:
- an overview of how the FDA currently uses RWE and what a future in which RWE is commonly used might look like;
- a deeper dive into new research describing the current use and contribution of RWE, the implications for and needs of the patient and patient advocacy community, and how the patient community is preparing for broader use of RWE;
- a payer’s perspective on the current use of RWE, how the payer community is preparing to use RWE more consistently, and whether the RWE standards for payment and coverage will be similar to or different from the standards for regulatory decisions; and
- an industry perspective describing how industry is using RWE today, how this may or may not change due to the FDA framework, and how the framework will affect evidence development intended for other health care decision-makers.
- Jennifer Graff, PharmD, Vice President, Comparative Effectiveness Research, National Pharmaceutical Council
- Eleanor Perfetto, PhD, MS, Senior Vice President, Strategic Initiatives, National Health Council
- Tricia Lee Wilkins, PharmD, MS, PhD, Director of Pharmacy Affairs, Academy of Managed Care Pharmacy
- Brande Yaist, MHS, Senior Director, Center of Expertise in Global Patient Outcomes and Real-World Evidence, Eli Lilly and Company