The G-BA took the opportunity to announce its AMNOG work programme for 2023 at a press conference on 14 February 2023. The impartial G-BA Chair professor Josef Hecken highlighted in his introduction speech that the G-BA had made over 1,000 benefit assessment decisions since the introduction of AMNOG and the mandatory assessment of new medicines in Germany in 2011.
The G-BA expects 130 new AMNOG benefit assessment resolutions in 2023. To assess the evidence, the G-BA will commission either IQWiG or – in the case of new orphan drugs – the G-BA Office. So far, pharmaceutical companies have reserved 260 paid consultations with the G-BA in 2023 to get ready for the specific evidence requirements. Professor Hecken informed that all consultation appointments are, in fact, booked and the number of requests clearly surpasses the G-BA resources. According to him, the high demand shows ‘how well-established and exemplary across Europe AMNOG meanwhile is’.
The G-BA Office in Berlin, Germany
Background
Pharmaceutical companies can request a consultation for their new medicine on the evidence requirements in Germany. These consultations are often early scientific advice and the participation of regulatory authorities is an option.
You can access available information in English on the benefit assessment of medicinal products according to AMNOG if you click the following links:
G-BA benefit assessment (Official G-BA website)
G-BA benefit assessment of orphan drugs (The first five years)