Decision C-3841/2023 of 6 May 2026

6 May 2026

In its judgment of 6 May 2026, the Federal Administrative Court (FAC, the Court) dismissed the appeal of Pierre Fabre Pharma AG against the Federal Office of Public Health (FOPH) and confirmed the price reduction of -8.8277858 % ordered for Tardyferon in the context of the 2021 triennial review of admission conditions for the List of Pharmaceutical Specialties (SL).

Pierre Fabre Pharma AG accepted the Foreign price comparison (Auslandpreisvergleich, APV) but challenged the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV), arguing that the FOPH had unlawfully restricted the comparison group to retard oral iron preparations (Gamme OralRetard) and should have included the non-retard preparations Duofer, Ferro Sanol and Maltofer (Gamme Oral) as genuine therapeutic alternatives, which would have resulted in a higher TQV price. It further argued a violation of the equal treatment principle, as Maltofer, a directly interchangeable and significantly more expensive product, had not been subject to equivalent price reductions in previous review cycles.

The Court dismissed the appeal. Referring to the Federal Supreme Court's prior judgment BGE 147 V 464 on the 2018 triennial review of Tardyferon, the court confirmed that the FOPH enjoys wide discretion in selecting TQV comparators and is not required to include all potentially comparable products. Restricting the TQV to same-gamme preparations was consistent with the cost-effectiveness principle (Kostengünstigkeitsprinzip) under art. 43 para. 6 of the Federal Health Insurance Act (Bundesgesetz über die Krankenversicherung, KVG), as the non-retard preparations were on average 16.02 % more expensive. Including them would have increased the TQV price, contrary to the law's cost-containment objectives. The equal treatment argument was equally dismissed, as each medicinal product must be assessed individually and the pricing of Maltofer fell outside the scope of the present proceedings.

For more information, see here.