Decision C-4589/2020 of 30 October 2023

15 novembre 2023 – In its decision of 30 October 2023, the Federal Administrative Court approved the appeal of an authorization holder regarding the triennial review of the admission requirements regarding the list of pharmaceutical specialties (LS). The cost effectiveness test for multi-indication preparations was disputed.

A. AG is the authorization holder of the drug B., which contains active ingredients C. and D. With an order dated 30 July 2020, the Federal Office of Public Health (FOPH) had reduced B.’s price.

According to the authorization holder, the FOPH relied on an incorrect main indication of B., which in her opinion led to an improper therapeutic cross-comparison (TCC). The court recognized that the corresponding prevalence figures to determine the main indication of B. for Switzerland are in fact missing. The lower instance therefore based its assessment of the main indication on incomplete facts. To determine the main indication of B., additional factors must be taken into account.

Furthermore, the authorization holder argued that none of the reference medicinal products were approved for the main indication of B and the selection was therefore incorrect. According to long-standing case law of the Federal Court, it does not appear appropriate for medicinal products to be included in the TCC that do not have the same main indication as the tested preparation or whose appropriate dosage has not been established in the indication. It is the responsibility of the lower instance to reassess the question of the economic viability of B. based on the dosages for the main indication. The FOPH must also investigate whether other preparations should be included in the comparison.

Finally, the authorization holder complained that the FOPH had wrongly ignored the price increases of active ingredient C. The court held that in individual cases, the FOPH can take the guarantee of the supply of medicines with a high medical need into account and, if necessary, forego a price reduction. In this case, however, the complainant had not provided relevant evidence to the effect that B. is a drug with a high medical need.

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