Kinderarzneimittel und Besonderheiten von pädiatrischen Studien im AMNOG

Abstract

The development and accessibility of paediatric medicinal products are subject to special support and regulation in the EU. As part of market access, new medicinal products undergo a benefit assessment in accordance with Section 35a SGB V after the German Act on the Reform of the Market for Medicinal Products (AMNOG) came into force in 2011. The additional benefit is assessed by the Federal Joint Committee (G-BA), after which the reimbursement amounts are negotiated with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband). Drugs that are given a new area of application are also subject to benefit assessment. These include extensions of the indication for paediatric patients. Medicinal products with a so-called PUMA authorisation (Paediatric Use Marketing Authorisation) are also affected by the AMNOG. The practical experience to date with the AMNOG benefit assessment for medicinal products with such authorisations is described below. The focus here is particularly on taking into account the special features of conducting paediatric clinical trials.