The applicant, IBSA Institut Biochimique Ltd., holds the marketing authorisation for Ialugen, a topical medicinal product listed in the List of Pharmaceutical Specialties (Spezialitätenliste, SL). Following a routine three-year review for SL products, the Federal Office of Public Health (FOPH) set new, significantly reduced prices for Ialugen based solely on a foreign price comparison (Auslandpreisvergleich, APV). The FOPH decided not to conduct a therapeutic cross-comparison (Therapeutischer Quervergleich, TQV) due to the absence of listed therapeutic alternatives. IBSA appealed, whereupon the FOPH reconsidered and issued a new order including a TQV with Flammazine as comparator. This resulted in slightly higher prices; however, these remained below the initial prices for Ialugen. IBSA also subsequently appealed this decision to the Federal Administrative Court. The Federal Administrative Court consolidated both proceedings and ultimately dismissed IBSA’s appeals, holding there were no suitable therapeutic alternatives warranting a TQV. It ordered that the lower prices set by the FOPH were to be reinstated. IBSA appealed to the Federal Supreme Court, seeking a re-determination of the prices.

The Federal Supreme Court held that under Swiss compulsory health insurance law, the criteria of efficacy, appropriateness and cost-effectiveness (Kriterien der Wirksamkeit, Zweckmässigkeit und Wirtschaftlichkeit, WZW criteria) apply, with prices generally to be determined by both APV and TQV unless no suitable comparator exists for the latter. The Court stressed that only medicinal products which are genuine therapeutic alternatives are eligible for TQV. It confirmed the case law of the Federal Administrative Court, according to which medicinal products with more than one indication may be included in the TQV, if they cover the indications of the medicinal product under review as comprehensively as possible. The Court agreed with the Federal Administrative Court that Flammazine, as an infection prevention, and Ialugen Plus, which includes an anti-infective component, cannot be regarded as suitable alternatives to Ialugen, a pure wound healing product, for TQV purposes due to their additional indications. As no comparable alternative existed, the exclusive reliance on APV for price setting was lawful. Thus, the most recent order of the FOPH was corrected accordingly and the lower prices for Ialugen were restored.

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