Federal Administrative Court, Decision C-6117/2018 of 22 September 2021

14 ottobre 2021 – In its decision, the court had to examine whether the price reduction ordered in the context of the triennial review of the admission conditions of a medicinal product on the list of pharmaceutical specialities was lawful. Since the medicinal product in question is not on the market in any reference country, the Federal Office of Public Health (FOPH) rightfully based its assessment solely on a TQV. The court reaffirmed that the TQV is calculated on the basis of the daily therapy costs indicated in the SmPC. Otherwise the costs of treatment per day or cure of the respective medicine are not reflected correctly. It was disputed according to which dosages the daily therapy costs are calculated. Only if no exact dosage instructions are indicated in the SmPC, an approximate determination of the daily dosage (such as the mean value of the dosage range indicated in the SmPC) used in outpatient treatment is admitted. The consideration of dosages used in stationary treatments by the FOPH correspond to an off-label use not permitted in the calculation of the TQV The FOPH further failed to give a justification for using the smallest package with a higher dosage in its calculations rather than the lowest dosage in accordance with the principle of art. 65d para. 3 of the Ordinance on Health Insurance.

The court concluded that the price reduction was neither based on a TQV carried out in accordance with the law nor based on a factual situation that had been clarified in a legally acceptable manner. Therefore, the court annulled the ruling and referred the case back to the lower instance.

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