In its decision of 13 December 2024, the Federal Administrative Court dismissed the appeal by A. AG, the marketing authorization holder for the medicinal product B. The appeal challenged the ruling of the Federal Office of Public Health (FOPH), which mandated the removal of a specific capsule size of the medicinal product B. (xx mg and xy units) from the List of Pharmaceutical Specialties (Spezialitätenliste, SL).

The court first addressed the appellant's claim that the removal violated its right to a fair hearing, specifically arguing that the initial decision lacked sufficient reasoning. However, the court found that, despite the absence of a detailed explanation in the initial decision, the appellant had been afforded ample opportunity to respond to the FOPH’s reasoning. Moreover, any deficiencies in the reasoning were addressed during the proceedings. Therefore, the court concluded that there was no violation of the appellant's right to be heard.

In assessing the matter, the court focused on whether the FOPH’s decision complied with the relevant legal standards, particularly in terms of the efficacy, appropriateness, and cost-effectiveness (Kriterien der Wirksamkeit, Zweckmässigkeit und Wirtschaftlichkeit, WZW criteria) of the disputed capsule size. The court affirmed that, under the Federal Health Insurance Ordinance (Krankenversicherungsverordnung, KVV), a medicinal product may be removed from the SL if it no longer meets the WZW criteria. The court agreed with the FOPH’s assessment that the disputed capsule size was impractical for patients, as it would necessitate the consumption of multiple capsules, resulting in higher costs for mandatory health insurance (obligatorische Krankenpflegeversicherung, OKP) and an increased risk of incorrect dosage. Consequently, the court concluded that the disputed capsule size no longer met the WZW criteria.

Furthermore, the appellant argued that the removal of the disputed capsule size was disproportionate, suggesting that a price reduction would have been a more reasonable alternative. The court rejected this argument, emphasizing that a price reduction would not address the core issue of the product’s impracticality and the associated risks. The court further noted that sufficient alternative medicinal products were available on the SL, and that removing the disputed capsule size would not create a gap in treatment options.

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