Facts
As part of the three-yearly review of the admission conditions for pharmaceutical products in the list of pharmaceutical specialties and packaged pharmaceutical products with prices (Specialty List), the Federal Office of Public Health (FOPH) informed A. SA about the review of the pharmaceutical product B. Since B. was not available on the market in any of the six reference countries, the cost-effectiveness was assessed solely on the basis of a therapeutic cross-comparison (TQV) with the pharmaceutical product C. Taking into account the new ex-factory price of C. as of November 1, 2013, the TQV resulted in a reduction rate of 48.03%, which was applied to the entire range of B.
A. SA filed a complaint against the FOPH's decision of September 5, 2013, which the Federal Administrative Court dismissed after a double exchange of written submissions with a decision dated March 14, 2016. Thereupon, A. SA filed a public law appeal with the Federal Supreme Court, requesting the annulment of the Federal Administrative Court's decision and the FOPH's decision.
Considerations
The Federal Supreme Court examined whether the use of the ex-factory price of the comparator pharmaceutical product C. applicable as of November 1, 2013 was lawful.
The Federal Supreme Court concluded that the interpretation of Art. 65d para. 1 of the Health Insurance Ordinance (KVV), according to which the TQV is based on the ex-factory price of the comparator pharmaceutical product as of November 1 of the review year, is in accordance with federal law. This corresponds to the goal of the three-yearly review of the admission conditions, that the pharmaceutical products on the…