[Reporter's View]Industry expectations rise with new changes
By Eo, Yun-Ho | translator Alice Kang
24.10.10 05:17:45
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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: ▲ there is no substitutable or therapeutically equivalent product or treatment ▲ a significant clini
Eo, Yun-Ho(unkindfish@dailypharm.com)
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