Value & Outcomes Spotlight: Using RWE/RWD to Drive Health Policy

Real-world evidence (RWE) and real-world data (RWD) are increasingly relied upon by regulatory agencies and health technology assessment (HTA) bodies for decision-making. In a new article, Value & Outcomes Spotlight’s editor-in-chief Zeba Khan, RPh, PhD, discusses the how RWD and RWE are currently used in health policy and how they can be leveraged to guide future policy directions.

According to Khan, “Globally, RWE is being increasingly recognized and utilized by various health policy stakeholders including regulatory agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Agencies such as these are already relying on RWD and RWE for monitoring post-market safety and adverse events and making regulatory decisions. The 21st Century Cures Act passed by the US Congress in 2016 emphasized to federal agencies—primarily the FDA—the utility of RWD and the resulting RWE to support its regulatory decisions particularly in the approval of new indications for existing therapies.”

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(Source: ISPOR, March/April 2022)