Federal Administrative Court, Decision C-641/2018 from 1 December 2021

27 gennaio 2022 – Presently, the appellant contested the legality of the TQV on the basis of which the Federal Office of Public Health (FOPH) ordered a price reduction in the context of the triennial review of the admission conditions. In particular, the appellant argued that the medicinal product in question presented a therapeutic advance due to its galenic form, which was not taken into account by the FOPH in the context of its determination of the price. Accordingly, the Court had to assess whether the conditions for granting an innovation surcharge – i.e. a significant added therapeutic value – were met in the case at hand. Contrary to the statements of the FOPH, the Court held that for assessing whether a medicinal product had such an added therapeutic value over another, direct comparative studies were not necessarily required. Hence, the Court had to determine whether such an added therapeutic value existed on the basis of the SmPC, expert opinions as well as studies submitted by the appellant. However, the Court concluded that the technology of the medicinal product in question had no significant additional benefit based on the documents and studies available.

Therefore, the Court dismissed the appeal.

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