Abstract
Within the scope of the German Health Technology Assessment (HTA) process, both the Federal Joint Committee (G-BA) and the pharmaceutical manufacturers can initiate a renewed benefit assessment based on new scientific findings in accordance with the social code book five, section §35a based on new scientific findings. In addition, the G-BA may impose a time limit on the decision if it is unclear whether the additional benefit derived from the submitted data will be confirmed during longer follow-up or if relevant results from studies are still pending.
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