Conducting a G-BA advice meeting

Here, advice obtained from the German Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) is substantially different from advice meetings / adboards at the EMA or the FDA. Thus, it is essential to meticulously prepare the potential questions, while concurrently anticipating the respective answers from the G-BA and their individual impact on the whole market access process. An individual evaluation of the chances and risks associated with each question can only be done with profound experience. Without experience and a sound strategy, certain aspects that might appear negligible could jeopardize the whole business case – and in the worst case prevent the patients' access to the respective drug in Germany.

SKC supports clients in an all-encompassing yet tailor-made strategic and operative manner to achieve the optimal outcome. When assessing and defining the set of questions for the G-BA – after an extensive analysis of the client's situation – thinking out of the box of the "usual suspects" often brings otherwise untouched chances for the overall process. In addition, sometimes it is not only about content but more about the tone and wording. As a synergistic benefit, SKC usually conducts a G-BA advice meeting as part of the overall German market access project. Here, the assist is as essential as the goal.