Facts
As part of the triennial review of the admission conditions for pharmaceuticals on the Specialty List (SL), the Federal Office of Public Health (FOPH) informed A. AG on March 13, 2014 that the pharmaceutical B. would be reviewed. Since B. was not marketed in any of the six reference countries, its cost-effectiveness was to be assessed solely based on a therapeutic cross-comparison (TQV) with the pharmaceuticals C. and D. A. AG objected to this comparison group formation and requested that the pharmaceuticals E., F. and G. also be included in the TQV.
The Federal Administrative Court dismissed the complaint of A. AG. Thereupon, A. AG filed an appeal in public law matters with the Federal Supreme Court, requesting the annulment of the decision of the Federal Administrative Court and the ruling of the FOPH.
Considerations
The Federal Supreme Court dismissed the appeal. It stated that the decision on the formation of the comparison group within the framework of the TQV has a discretionary character both with regard to the criteria "same indication" and "similar mode of action" as well as with regard to the selection and number of pharmaceuticals to be included. The administration was therefore allowed in the present case to limit the comparison group to pharmaceuticals with practically identical indications according to the Swissmedic product information and the same dispensing category.
The Federal Supreme Court did not see any abuse of discretion in this procedure. The restriction to pharmaceuticals with largely identical indications corresponds to the case law of the Federal Supreme Court, according to which comparability can only be affirmed if there is no significant difference between the pharmaceutical to be reviewed and the…