Facts
As part of the triennial review of the admission requirements for pharmaceutical specialties in the Specialty List (SL), the Federal Office of Public Health (FOPH) informed A. AG about the review of pharmaceutical specialties with an SL admission date of 2010, 2007, 2004, 2001, etc. Pursuant to Art. 65d para. 1bis of the Health Insurance Ordinance (KVV), the FOPH assessed the cost-effectiveness of the pharmaceutical specialty B. solely based on a foreign price comparison (APV), without conducting a therapeutic cross-comparison (TQV). The FOPH informed A. AG that B. was too expensive compared to the foreign average price and therefore intended to reduce the price by 25.69%.
A. AG filed an appeal against the FOPH's decision. The Federal Administrative Court annulled the decision and referred the matter back to the FOPH, so that it could make a new decision on the price reduction after clarification in the sense of the considerations (examination of the admission requirements including APV and TQV).
The FOPH then filed an appeal in public law matters with the request to set aside the decision of the Federal Administrative Court and to confirm the FOPH's decision of September 19, 2013.
Considerations
The Federal Supreme Court dismissed the FOPH's appeal. It stated that Art. 65d para. 1bis KVV, which provides for a review based solely on price, is not compatible with the principle of legality. The periodic review pursuant to Art. 32 para. 2 KVG must be comprehensive, including a cost-benefit analysis. An indirect cost-benefit analysis is carried out through a therapeutic cross-comparison.
The…