26 agosto 2024 – In its decision of 16 July 2024, the Federal Supreme Court dismissed the appeal of the Federal Office of Public Health (FOPH) against the decision of the Federal Administrative Court concerning the triennial review of admission requirements of the medicinal product Duodart regarding the List of Pharmaceutical Specialties (Spezialitätenliste, SL). The decision is intended for publication as a leading decision in the official collection of the Federal Supreme Court.

The dispute centred on whether the Federal Administrative Court had violated federal law by overturning the price reduction of Duodart as requested by GlaxoSmithKline AG, the marketing authorization holder. It was established that Duodart holds a valid marketing authorization from Swissmedic and that it continues to meet the criteria of efficacy and appropriateness as part of the triennial review. Its cost-effectiveness was to be assessed, inter alia, through a comparison with the prices in reference countries (Auslandpreisvergleich, APV), which remained uncontested.

However, it was disputed whether generics could be included as comparator products in the therapeutic cross comparison (Therapeutischer Quervergleich, TQV) for Duodart. According to FOPH practice and guidelines, off-patent originator products with a single active ingredient may only be compared with other off-patent originator products. The law does not differentiate between single-ingredient and multi-ingredient originator products in terms of pricing. The Federal Supreme Court concluded that the same must apply to off-patent originator products with two or more active ingredients. Comparisons with generics are inadmissible, as the court confirmed, due to fundamental differences in pricing methodologies. While the price of originator products is based on APV and TQV, the price of generics must maintain a certain price gap with the originator product. According to the court, the FOPH was using circular reasoning by pricing originator products on the basis of generics whose prices in turn depend on the prices of the originator products. The court also pointed to differences in the rules governing co-payments and the marketing authorization process.

In addition to the inclusion of generics, the appropriate package size on which the TQV is based was also disputed. As the comparator products for Duodart have not yet been definitively identified, the court refrained from assessing the correct packaging size, stating that further clarification was required from the FOPH and that a final decision on the size of the package was premature at this stage.

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