Facts
A. AG is the marketing authorization holder for medication X., which is approved by the Swiss Agency for Therapeutic Products (Swissmedic) and is listed in the List of Pharmaceutical Specialties and Packaged Medicines with Prices (Specialty List [SL]). The Federal Office of Public Health (FOPH) informed A. AG that X. would be subject to the triennial review of the admission conditions for the products listed in the SL. The FOPH concluded that for the therapeutic cross-comparison (TQV), only medication U. should be used, as it, like X., contains the active ingredient B. and can be considered in the same dosage per unit. As the parties could not reach an agreement, the FOPH ordered on December 14, 2017 a reduction of the prices of X. by 25.7841248% to the new price of CHF 169.42 (ex-factory price) or CHF 210.90 (consumer price; X. Multidose) or CHF 212.67 (ex-factory price) or CHF 260.55 (consumer price; X. Ampoule) as of February 1, 2018.
Considerations
The Federal Supreme Court notes that the FOPH, in carrying out the TQV, must assess the cost-effectiveness of a medicinal product in accordance with Art. 65b para. 2 lit. b KVV on the basis of "the comparison with other medicinal products". According to Art. 65b para. 4bis KVV and Art. 34f para. 1 KLV, the circle of medicinal products to be used for the TQV is limited to those "used to treat the same disease".
The Federal Supreme Court…