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  • [Reporter's View]Industry expectations rise with new changes
  • by Eo, Yun-Ho | translator Alice Kang | Oct 10, 2024 05:50am
Industry expectations rise with the new changes made to the preferential treatment for innovative new drugs and RSA expansion measures
The criteria for innovative new drugs that are eligible for the flexible application of the ICER threshold and the measures for the expansion of the risk-sharing agreement (RSA) have been revealed. As always, the industry expressed a mix of expectations and concerns.

The disclosed ¡®Detailed evaluation criteria for new drugs etc. subject to negotiations¡¯ goes as follows. Firstly, the requirements for ¡®innovativeness¡¯ to qualify for the flexible application of the ICER threshold were established.

A new drug is regarded as ¡®innovative¡¯ when it satisfies all of the following criteria: ¡ã there is no substitutable or therapeutically equivalent product or treatment ¡ã a significant clinical improvement, such as
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