S Bittner1, S G Meuth2. 1. Klinik für Neurologie, Johannes Gutenberg Universität Mainz, Langenbeckstraße 1, 55131, Mainz, Deutschland. stefan.bittner@unimedizin-mainz.de. 2. Klinik für Translationale Neurologie, Universitätsklinikum Münster, Münster, Deutschland.
Abstract
BACKGROUND: The treatment of patients with multiple sclerosis (MS) is associated with constantly rising costs for the healthcare system and pharmaceuticals constitute 60 % of the direct medical costs. The Pharmaceutical Market Restructuring Act (Arzneimittelmarkt-Neuordnungsgesetz, AMNOG) came into force on 1 January 2011 with the aim of limiting the costs of pharmaceuticals by obligating newly approved products to be subjected to an early evaluation of the additional benefits by the Federal Joint Committee (FJC, Gemeinsamer Bundesausschuss, G‑BA). The majority of products evaluated up to October 2015 in neurology (5 out of 8) were approved for treatment of MS. OBJECTIVE: Has the AMNOG been able to fulfill the original aims? MATERIAL AND METHODS: Analysis of available information on MS therapies evaluated by the FJC between December 2010 and October 2015. RESULTS: For various reasons an additional benefit could be shown in only 2 out of 5 assessment procedures for MS drugs. It is obvious that some methodological shortcomings of the process have to be improved. Additionally requirements for pivotal clinical trials have to be harmonized with AMNOG requirements taking the best available evidence and real-life data into consideration (e.g. non-interventional studies) and a closer collaboration between the FJC, healthcare providers and the neurological societies is necessary. CONCLUSION: The AMNOG procedure currently only partially fulfills the original aims, which could be the reason why guidelines play a more important role for therapy decision-making than FJC decisions. As the early evaluation procedure is an adaptive process methodological shortcomings might be overcome in the future; however, this requires a much closer collaboration between the FJC and neurological societies.
BACKGROUND: The treatment of patients with multiple sclerosis (MS) is associated with constantly rising costs for the healthcare system and pharmaceuticals constitute 60 % of the direct medical costs. The Pharmaceutical Market Restructuring Act (Arzneimittelmarkt-Neuordnungsgesetz, AMNOG) came into force on 1 January 2011 with the aim of limiting the costs of pharmaceuticals by obligating newly approved products to be subjected to an early evaluation of the additional benefits by the Federal Joint Committee (FJC, Gemeinsamer Bundesausschuss, G‑BA). The majority of products evaluated up to October 2015 in neurology (5 out of 8) were approved for treatment of MS. OBJECTIVE: Has the AMNOG been able to fulfill the original aims? MATERIAL AND METHODS: Analysis of available information on MS therapies evaluated by the FJC between December 2010 and October 2015. RESULTS: For various reasons an additional benefit could be shown in only 2 out of 5 assessment procedures for MS drugs. It is obvious that some methodological shortcomings of the process have to be improved. Additionally requirements for pivotal clinical trials have to be harmonized with AMNOG requirements taking the best available evidence and real-life data into consideration (e.g. non-interventional studies) and a closer collaboration between the FJC, healthcare providers and the neurological societies is necessary. CONCLUSION: The AMNOG procedure currently only partially fulfills the original aims, which could be the reason why guidelines play a more important role for therapy decision-making than FJC decisions. As the early evaluation procedure is an adaptive process methodological shortcomings might be overcome in the future; however, this requires a much closer collaboration between the FJC and neurological societies.