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Tuesday, July 22, 2014 2:58:13 AM
I do not agree with his assumption (my first and only disagreement so far). I think all German agencies act very independently from each other unless specifically stated. Thus, the assessment performed by the PEI to grant hospital exemption to DCVax-L is not sufficient for pricing negotiations.
On Slide 16, it states that the benefit assessment for pricing negotiations must be conducted by the IQWiG and then proven by G-BA. As the PEI is not highlighted anywhere in this slide, I am assuming a new benefit assessment has to be executed.
If my assumption regarding the strict independent nature of each regulatory agency highlighted above is correct AND that the negotiation process began immediately after hospital exemption approval was granted, then I believe pricing negotiations will be complete somewhere around Feb / Mar 2015.
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