New framework expected to improve reliability of real-world evidence-based drug performance assessments

The Health Insurance Review and Assessment Service headquarters in Wonju, Gangwon Province [Health Insurance Review and Assessment Service]
The Health Insurance Review and Assessment Service headquarters in Wonju, Gangwon Province [Health Insurance Review and Assessment Service]

The Health Insurance Review and Assessment Service announced Thursday that it has established guidelines for generating Real-World Evidence (RWE) to evaluate the performance of drugs listed under the national health insurance system.

For some drugs recently added to the national health insurance formulary, clinical trial data alone can be insufficient to confirm how they perform in actual use. The new guidelines address this uncertainty by outlining key considerations for generating evidence from Real-World Data (RWD).

The agency said it gathered input from stakeholders during the research and development process and verified the feasibility of applying real-world data. The final guidelines were drawn up after additional rounds of consultation with experts and the pharmaceutical industry.

The guidelines cover the definitions of RWD and RWE, research planning, data quality management, and methods for reporting results, and are available on the agency's website.

"Drug performance evaluation is a critical process for confirming whether treatments translate into real health outcomes for patients in clinical settings," HIRA President Hong Seung-kwon said. "We hope these guidelines will particularly help assess the real-world results of drugs reliably in areas where evidence uncertainty is high, such as rare and serious diseases."


thlee@heraldcorp.com