Wednesday, Jan. 30, 1 p.m.-2 p.m. ET
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. NPC has been playing a leading role in encouraging the use of high-quality methodology and standards to conduct real-world research and helping decision-makers understand how to evaluate and use RWE. But how is RWE really being used and how will the FDA framework affect decision-makers beyond the FDA?
The National Pharmaceutical Council hosted a webinar on Jan. 30 from 1 p.m. to 2 p.m. ET that showcased the potential implications of the FDA framework for patients, payers, manufacturers and other health care stakeholders.
This webinar provides:
- 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 standards for RWE for payment and coverage will be similar or different from the standards for regulatory decisions;
- 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
- Brande Yaist, MHS, Senior Director, Center of Expertise in Global Patient Outcomes and Real-World Evidence, Eli Lilly and Company
- Eleanor Perfetto, PhD, MS, Executive Vice President, Strategic Initiatives, National Health Council
- Tricia Lee Wilkins, PharmD, MS, PhD, Director of Pharmacy Affairs, Academy of Managed Care Pharmacy
In the past few weeks, the FDA reopened the Framework for a Real-World Evidence Program; Availability comment period until April 16th. To learn more about the framework, view the recorded webinar in NPC's video archives, read NPC's comment letter to the FDA on its RWE framework and check out the RWE section of our research library.