Federal Administrative Court, Decision C-913/2019 of 3 February 2021
2 April 2021 – In this decision, the Federal Administrative Court assessed whether the Federal Office of Public Health (FOPH) carried out the therapeutic cross comparison (Therapeutischer Quervergleich, TQV) within the context of the three-yearly price review correctly. It was not the medical authorisation that was in dispute, but only the calculation methods used for the TQV. The appellant claimed, inter alia, an infringement of his right to be heard, because the FOPH had given insufficient justification for its decision – it had only stated that it could not understand the appellant’s calculations in connection with the TQV. The Federal Administrative Court rejected this claim and held that although the justification had been brief, no infringement of the right to a reasoned decision was identifiable, since a proper objection of the ruling was readily possible. Subsequently, the Federal Administrative Court discussed the methods and studies used for the TQV in detail. Particularly, it examined whether the FOPH was correct in basing its decision on the costs per day instead of the costs per course of treatment and whether the FOPH was right in omitting the consultation of certain pharmaceutical economic studies. However, in the end, the Court did not decide on these questions, as it was not possible to determine how long an average therapy with the medicinal product lasts due to the absence of clinically controlled studies. The contested ruling was already for this reason not based on a TQV carried out in a legally compliant manner, which is why the price reduction ordered by the FOPH was qualified unlawful. The appeal was upheld, FOPH must re-assess.
For more information, see here.