Nicht belegter Zusatznutzen durch späte Änderungen der zweckmäßigen Vergleichstherapie

As part of the early benefit assessment, the added benefit of new medicinal products protected by documentation is assessed in comparison to the appropriate comparator therapy (ACT). At the request of the pharmaceutical company (MAH), the Federal Joint Committee (G-BA) discusses the documents to be submitted and the ACT. The G-BA can adjust the zVT determined in the course of a consultation over time. This can also be done after the start of a benefit assessment. In this paper, examples are presented that show how the change of the zVT in the ongoing benefit assessment procedure can lead to a usable randomised controlled trial (RCT) not being considered by the G-BA, which in turn leads to an unproven added benefit. Results: In this analysis, four practical cases were presented in which the manufacturer was confronted with the situation of an unsuitable study comparator due to a zVT amendment in the ongoing benefit assessment procedure. For example, drugs for the treatment of head and neck tumours, multiple sclerosis or chronic rhinosinusitis were denied the additional benefit initially determined by the Institute for Efficiency and Quality in Health Care (IQWiG) in the procedure in the final G-BA decision due to short-term changes to the zVT.