In its decision C-146/2022 of 28 July 2025, the Federal Administrative Court upheld the appeal filed by the marketing authorisation holder of Buccolam Oral Flüssig (Buccolam). The complaint was directed against a price reduction imposed by the FOPH as part of its triennial review. The point of contention was the inclusion of magistral prescriptions not listed in the list of pharmaceutical specialties (Spezialitätenliste, SL) in the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV), which the marketing authorization holder contested.

The court held that only branded preparations as well as other preparations that were on the SL could be used in the TQV since their price was determined by the economic comparison procedure put forward in Art. 65b para. 2 of the Ordinance on Health Insurance (Verordnung über die Krankenversicherung, KVV). Magistral prescriptions were neither on the SL nor were their prices determined in an economic comparison procedure. Therefore, they could not be used in the TQV.

The court concluded that no comparable preparation existed, which was why no TQV could be carried out for Buccolam. Therefore, the criterion of cost-effectiveness would be determined solely by performing the international price comparison (Auslandspreisvergleich, APV). As a result, the price of Buccolam did not need to be reduced.

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