Facts
A. AG is the marketing authorization holder for the medicinal product B. ®, which is used to treat various types of cancer. The medication was included in the Specialty List (SL) in 2010 with a limitation. At the request of A. AG, the Federal Office of Public Health (FOPH) temporarily approved an expansion of the limitation for the indication of breast cancer in 2013.
In 2016, the FOPH extended the limitation until March 31, 2017, and reduced the prices. The FOPH required that A. AG submit a regular application for the expansion of the limitation for the indication of breast cancer before the expiration of the limitation, which would then be examined by the Federal Drugs Commission.
Since no agreement could be reached on the formation of the comparison group for the therapeutic cross-comparison (TQV) and thus the price of B. ® during the economic efficiency review, the FOPH rejected the application for the expansion of the limitation by decision of May 31, 2018. A. AG then filed a complaint with the Federal Administrative Court, which dismissed the complaint and instructed the FOPH to remove the expanded limitation of B. ® for the indication of breast cancer from the SL.
Considerations
The Federal Supreme Court notes that the Federal Administrative Court correctly applied the relevant provisions of the Health Insurance Act. In particular, it is permissible within the framework of the TQV to disregard medicinal products that are more…