21. April 2022 – With this decision, the Federal Supreme Court ruled on an appeal of the Federal Office of Public Health (FOPH) against a decision of the Federal Administrative Court C-913/2019 of 3 February 2021, which had already been discussed in an earlier newsletter (see our Newsletter hereto). In the contested decision C-913/2019 of 3 February 2021, the Federal Administrative Court assessed whether FOPH had carried out the therapeutic cross comparison (Therapeutischer Quervergleich, TQV) within the context of the three-yearly price review correctly. The dispute was about the calculation methods used for the TQV. Particularly, the court 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. The Federal Administrative Court ruled that the TQV had not been carried out in a legally compliant manner and therefore annulled FOPH's contested ruling of 21 January 2019 (see our Newsletter hereto). In this decision from 17 March 2022, the Federal Supreme Court ruled that if the product information clearly states the recommended or usual dosage with regard to the average maintenance dose, this must be used as the basis for the TQV. In the absence of such precise information, the entire dose range listed in the SmPC is to be taken into account, whereby its mean value is to be used. The therapy with the relevant medicinal product and its comparative medicinal product is limited in time to the treatment of the acute situation so that the use of both products is not a permanent therapy, but a temporally closed course of treatment. Whereas the maximum duration of the treatment with the relevant medicinal product is limited, the product information of the comparative medicinal product does not provide any information on the maximum duration of treatment, so that the average duration of therapy cannot be clearly determined.

Accordingly, the Federal Supreme Court confirmed the decision of the lower court on the finding of a positive reduction rate and rejected the appeal.

For more information, see here.