12 April 2024 – In its ruling of 20 March 2024, the Federal Administrative Court rejected the appeal of a pharmaceutical company against the decision of the Federal Office of Public Health (FOPH) regarding the triennial review of the inclusion conditions of the medicinal product B. The appellant objected to the limitation of the therapeutic use of B. and the non-inclusion of B. in the List of Pharmaceutical Specialties (Spezialitätenliste, SL) for prophylactic use in the general population.

The court held that the prophylactic use of B. continued to be indicated only for specific cohorts with an increased risk of certain D. deficiency (anonymised in the decision). The appellant sought to extend the scope of the inclusion of B. in the SL for prophylactic purposes to the general population. The FOPH had approved B.'s inclusion in the SL on condition that its prophylactic use was restricted to selected population groups at increased risk of D. deficiency.

Rejecting the pharmaceutical company's appeal, the court confirmed the FOPH's prerogative to reassess the suitability of B. in the context of its triennial review of the criteria and to impose restrictions accordingly. The FOPH had concluded that the prophylactic use of B. in the general population is unjustified and leads to unnecessary expenditure. The appellant was unable to challenge this assessment.

In addition, the court found that the restriction imposed was proportionate and represented the least intrusive measure to reduce costs for the public health insurance system. The additional benefits derived from the prophylactic medical use of B. pale in comparison to the total costs borne by the public health insurance system. The restriction imposed by the FOPH in accordance with Article 12 of the Insurance Ordinance on Healthcare Benefits (Krankenpflege-Leistungsverordnung, KLV) remained unchallenged.

Consequently, the restriction of B. to its therapeutic use, as prescribed by the FOPH within the framework of a permissible change in practice, does not give rise to any objections.

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