In the consultation meeting at the G-BA, it is mainly the appropriate comparator therapy for a new medicinal product that is determined. In addition, questions regarding the study design and the endpoints of a study may be addressed. The G-BA consultation is based on a written request by the pharmaceutical company which is processed by the Pharmaceuticals Subcommittee of the G-BA. In addition, an oral consultation with the G-BA is conducted in order to answer and discuss the questions submitted by the pharmaceutical company. Our services include the preparation of the written G-BA consultation request according to methods of evidence-based medicine as well as the preparation of the content and training for the consultation meeting with the G-BA.
The early benefit assessment process provides for a hearing phase following the benefit assessment. The hearing consists of a written statement and an oral hearing before the G-BA. In the written statement, the results of the benefit assessment can be commented on and discussed and, if necessary, further data can be submitted. The statement period is 3 weeks after publication of the benefit assessment. This is followed by an additional oral hearing before the G-BA where further questions can be discussed whilst also involving the expert groups and associations of the pharmaceutical industry. Due to its structure and process, the oral hearing represents a special challenge which requires specific preparation.
Our services include the preparation of the written statement based on the results of the IQWiG / G-BA benefit assessment as well as specific training, practical exercises and simulations to prepare for the oral hearing.