Although a process of assessing DiHA with regard to coverage decisions was set up in Germany in 2019, there is no study analysing its findings. Therefore, this study aims to investigate the first results of the fast-track pathway while especially focusing on the evidence evaluation of DiHA. Additionally, risk of bias of clinical trials used in the decision-making process of the German fast-track pathway was assessed.
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Figure 2 gives an overview on the methods of the study. We identified between 08/2021 and 02/2022 all DiHA listed in the DiHA directory and respective decision documents of BfArM [22] used during the fast-track evaluation between 09/2020, when the first decisions were made, and 02/2022.
There are similarities with the procedure for new pharmaceuticals entering the market, e.g. free price setting in the first year, or price negotiations between the manufacturer and the Federal Association of Statutory Health Insurance Funds with valid prices from the 13th month after market approval for pharmaceuticals (DiHA: price negotiations with valid prices from the 13th month after inclusion in the DiHA registry) [55]. However, the transparency of the fast-track assessments of the benefit of DiHA at the BfArM should be improved. Until now it is unclear whether the body of evidence included in the assessment is complete and to what extent the quality of the evidence and the extent of the positive health care effect are included in the reimbursement decision, while pharmaceuticals are subject to price negotiations according to the level of the additional benefit. 2ff7e9595c
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