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Is RWD needed for post-listing control of PE exempt drugs?

By Eo, Yun-Ho | translator Alice Kang

24.12.02 05:55:12

가나다라 0
The lack of robustness in data criticized…has clear limitations over RCT

Can manage high-priced drugs with existing RSA pathways such as Performance-based type and Expenditure Cap type RSA



The budget is tight, but the use of high-priced drugs continues to rise. The government is beginning to feel the strain of the systems it has put in place to increase access to new drugs, especially the pharmacoeconomic evaluation (PE) exemption system, which is increasingly being utilized and being subject to criticism.

"The purpose of the post-listing control system is to secure additional evidence for medicines that have unclear safety and efficacy for patients. It will improve the quality of Korea’s healthcare by providing a medical reaffirmation process for such medicines."

This was the government's stated intent. The government's good intentions aside, the industry has not

Eo, Yun-Ho(unkindfish@dailypharm.com)
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