Federal Administrative Court, Decision C-3382/2018 of 26 January 2020
18 February 2020 – In a recent decision, the Federal Administrative Court rejected an appeal against an order of the Federal Office of Public Health (“FOPH”) which denied the applicant’s request to extent the limitation of a medicinal product on the list of specialities to a specific indication. The FOPH held in its order that the criteria of effectiveness and appropriateness may be regarded as fulfilled for a limited period of time, but the medicinal product was according to a therapeutic cross-comparison (Therapeutischer Quervergleich; TQV) not economically efficient at the current price on the list of specialities with regard to this specific indication. In its decision, the Federal Administrative Court held that the FOPH has considerable discretion in order to decide which medicinal products may be used within the TQV. The Court ruled that the applicant's medicinal product was compared with a suitable and comparable medicinal product, as both are potential treatments for the same disease. It was irrelevant that the two drugs had a different mechanism of action (mono therapy vs. combination therapy). Furthermore, there is no obligation for the FOPH to include all medicinal products in question in the TQV. Accordingly, the Federal Administrative Court concluded that the FOPH conducted the examination of economic efficiency in conformity with the law.
For the full decision, see here.