Federal Supreme Court, Decision 9C_612/2020 from 22 September 2021

21. Oktober 2021 – It was disputed whether the price reduction by the Federal Office of Public Health (FOPH), which was further increased by the Federal Administrative Court, was lawful, in particular whether the TQV was carried out in a legal manner (cf. C-6091/2018 from 20 August 2020). The court held that if exact dosage instructions can be found in the SmPC, on the basis of which the average daily therapy costs can be calculated, these are to be used. Pursuant to the court, the TQV of the medicinal product shall be carried out on the basis of the recommended initial or maintenance dosage according to the respective SmPC. This has to be considered the relevant "usual dose", insofar as corresponding information is available. If the latter is the case, there is no room for using the respective mean value of the dose range (which does not correspond to the relevant "average maintenance dose" in all cases). The SmPC of the majority of the comparative products in question contained a clear recommendation on the usual therapeutic dose. Accordingly, the court held that the TQV must be carried out on the basis of the mentioned "usual doses" of these medicinal products. Furthermore, one additional comparative medicinal product did not have to be considered for the TQV in question as, pursuant the court, four comparative medicinal products must be viewed to be sufficient to conduct a TQV. Accordingly, the FOPH and the Federal Administrative Court had based their TQV on the wrong dosage for certain medicinal products.

With regards to the question which galenic form – capsules or dispersing tablets – had to be used for the TQV, the court agreed with the view of the FOPH and the Federal Administrative Court (cf. C-6091/2018 from 20 August 2020).

To conclude, the court revoked the judgment by the Federal Administrative Court and the ruling by the FOPH as the TQV was not carried out in a legal manner.

For more information see here.