Die Festbetragsregelung im AMNOG-Markt – ein Blick aus der Praxis

The Pharmaceutical Market Reorganisation Act (AMNOG) was introduced by the legislator in 2010 as a supplement to the reference price system, which had already been in place for a long time. The AMNOG instruments were intended to regulate prices in the 'non-fixed price market'. The AMNOG obliges the National Association of Statutory Health Insurance Funds and the pharmaceutical company, as the explanatory memorandum to the law briefly and succinctly stated at the time, 'to agree a reimbursement amount for non-fixed-price drugs with new active ingredients with effect for all health insurance funds' (Deutscher Bundestag 2010: 31). In reality, however, the exact application and delimitation of both instruments were unclear. The categorisation of drugs without proven additional benefit into the reference price system was considered the standard case in the initial concept: 'Without additional benefit - transfer to the reference price system' was the chapter heading in the explanatory brochure of the Federal Ministry of Health on the AMNOG (BMG 2010: 16). In these cases, the reimbursement amount negotiation should only be necessary on an interim basis. On closer inspection, however, there was a lack of concrete guidelines as to which instrument should be used when and how the different regulatory logics of the two systems should be harmonised. De facto, the self-administration had a great deal of room for manoeuvre here. This article analyses how the reference price regulation has been applied in practice in the AMNOG market since 2011. After a brief explanation of the legal framework (1), different case constellations are presented and the procedural practices of the self-administration are analysed in each case (2). The analysis is based on all benefit assessment procedures published by the Federal Joint Committee (G-BA) up to and including 15 July 2024 in which the reference price regulation has become relevant. These 42 procedures for 27 medicinal products were classified and compared. The review is followed by a discussion of the challenges and problems arising from procedural practice (3). Overall, the present study shows that reference price regulations in the AMNOG market have so far tended to be a 'procedural sidetrack' in practice (4).