7. Juni 2024 – In its decision of 15 May 2024, the Federal Administrative Court upheld the appeal of an authorization holder (A. AG) regarding the triennial review of the admission requirements regarding the List of Pharmaceutical Specialties (Spezialitätenliste, SL). Subject to the appeal was the ordered price reduction for A. AG’s medicine B in 2017, which the court had already ruled on and referred back to Federal Office of Public Health (FOPH) by its decision (C-3805/2018).

The court ruled that the foreign price comparison (Auslandpreisvergleich, APV) was invalid because the FOPH had based it on current prices in 2021. Even if the subsequent implementation of the APV would have been permissible under Art. 34e para. 1 of the Ordinance on Healthcare Benefits (Krankenpflege-Leistungsverordnung, KLV), it would have had to be based on the prices of the reference countries as of 1 January 2017.

In addition, the court found that the FOPH had not considered the relevant date of 1 July 2017 when determining the calculation basis for the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV). With regard to the reference medicinal product P., which was not included in the SL until 2020, the court stated that this product could not be used for the 2017 triennial review due to the date of its inclusion.

As a result, the appeal was upheld, and the case was referred back to the FOPH – the FOPH will have to carry out a new price comparison in accordance with the reasoning and decide again on B.'s price as part of the triennial review in 2017.

For more information, see here.