13 novembre 2023 – In its decision of 28 January 2022, 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.

The Federal Administrative Court held that, to be included in the therapeutic cross-comparison (TCC), a comparison medicinal product must represent an actual genuine therapeutic alternative to the original medicinal product under review, even in the case of medicinal products with more than one indication (multi-indication products). A. AG is the authorization holder of the drug B., which is included in the list of pharmaceutical specialties (LS) in different dosage forms Ba. and Bb. The lower instance had considered the prevalence of asthma to be higher than that of COPD and therefore defined asthma as the main indication for drug B. (under triennial review) within the framework of the TCC without substantiating its assumption of prevalence. Asthma and COPD are estimated to occur at approximately the same frequency, which means that the main indication of drug B. cannot be determined based on prevalence figures alone. The court noted that there are medical reasons that speak against the main use of B. for asthma in long-term medical practice. The fact that the lower instance did not take these reasons into account when determining the main indication was in violation of federal law.

The court further investigated whether the TCC should be based on an average price for both dosage forms of B. or only on the price of Ba. The lower instance argued to only take dosage form Ba. into account because there was greater similarity and therefore better comparability of this dosage form with the dosage form of the comparison drugs. The court held that, if different pharmaceutical forms are available for medicinal product under review, each of which qualifies as the smallest package and lowest dosage and does not differ significantly from the pharmaceutical forms of the comparison medicinal products, it is justified to use the average price of these pharmaceutical forms within the framework of the TCC.

Finally, the court held that for the calculation of the daily therapy costs, the main use of the medicinal product in medical practice (so-called main indication) can be used as the basis for the cost effectiveness test. However, the theoretical applicability of a medicinal product derived from prevalence figures is irrelevant when determining the main indication.

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