Decision C-4921/2021 of 6 October 2023

24. November 2023 – In its decision of 6 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 for drug B. The authorization holder rejected the inclusion of generic drugs in the therapeutic cross-comparison (TCC) and requested that the TCC be based on the smallest size packaging of B. With an order dated 8 October 2021, the Federal Office of Public Health (FOPH) had reduced the prices of drug B.

The court held that the inclusion of generic drug prices in the pricing of original drugs turns out to be circular. Within the TCC, only drugs whose prices were also determined in the procedure pursuant to art. 65b para. 2 of the Ordinance on Health Insurance (HIO) may be used for comparison. An inclusion of generic drugs is not permissible.

The court further examined which packaging size the TCC should be based on. Generally, according to art. 65d para. 3 HIO, the TCC must be carried out on the basis of the smallest packaging and dosage size listed in the LS, although certain exceptions are permitted. C., however, is not available in small packaging whereas an adequate price comparison with D. is only possible with a comparison to the smallest packaging size due to high price impacts in bigger packaging. It follows that the usage of the average packaging size of B. does not enable an adequate comparison. The TCC must therefore be carried out based on the smallest available packaging size for each drug.

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