In its decision of 11 September 2024, the Federal Administrative Court partially approved the appeal of an authorization holder regarding the triennial review of the admission requirements regarding the list of pharmaceutical specialties (Spezialitätenliste, SL). The method used for the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV) was disputed.

The case concerned the triennial review of medicinal products, which is carried out every three years by the Federal Office of Public Health (FOPH) to ensure that the listed medicinal products still meet the conditions for inclusion. The medicinal products must therefore continue to meet the criteria of efficacy, appropriateness, and cost-effectiveness (Kriterien der Wirksamkeit, Zweckmässigkeit und Wirtschaftlichkeit, WZW criteria), and have a valid authorization (Article 65 para. 1 and 3 Ordinance on Health Insurance [Verordnung über die Krankenversicherung, KVV] and Article 30 para. 1 Ordinance on Healthcare Benefits [Krankenpflege-Leistungsverordnung, KLV]). As part of this process, the FOPH performs a TQV to assess how the effectiveness and cost of a medicinal product compare with other similar medicinal products used for the same conditions. In this context, the FOPH defined a new main indication for the medicinal product B., justifying this on the grounds that the indication was a broad generic term. This was accepted with reservations by the authorization holder. In addition, the FOPH used the fingertip unit (FTU) method to calculate the dosage and the daily cost of therapy. The authorization holder challenged this method, arguing that the FTU method was not appropriate for these products and that the cylinder method should be used instead. The FOPH nevertheless applied the FTU method and ordered a price reduction for B. and its two co-marketed products C. and D.

Due to their interrelated nature, the court consolidated the three appeals against these orders into a single proceeding due to their close connection. The court found that the FOPH's determination of the main indication lacked sufficient factual findings and required further clarification. Furthermore, the court stated that FOPH's use of the FTU method was also not sufficiently justified. In the opinion of the court, the general explanations were insufficient to make the application of the FTU-method appear appropriate and comprehensible with regard to the main indication.

Consequently, the court annulled the decision to lower the price of B., C. and D., remanding the case for further investigation and a new TQV process.

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