Decision C-5620/2020 dated 22 December 2022

13 gennaio 2023 – Drug B was subjected to the triennial review of the conditions for inclusion in the list of specialties by the Federal Office of Public Health (FOPH). For this purpose, a therapeutic cross comparison (Therapeutischer Quervergleich, TQV) of the marketing authorization holder with two other drugs was performed. In the case of drug F, the FOPH determined the average daily dosage as the mean value between the lowest and highest dosage, whereby lower dosages are only used for milder cases and long-term treatments. However, for drug B, the FOPH took the maximum dose as the mean daily dose, on the grounds that the wording in the technical information regarding a lower dose was not consistent with that for drug F. Subsequently, during the triennial review, the FOPH ordered a price reduction for B, which was based, among other things, on the TQV. The authorisation holder of drug B appealed against this. The Federal Administrative Court (the Court) ruled that the number of individuals responding to a lower dose was irrelevant in determining the average daily dosage. The entire dosage range must be considered. The FOPH had also violated the principle of equal treatment by considering only part of the dosage range for one drug and the entire dosage range for the other. The doses were all to be determined according to the same conditions for the TQV. If the average daily dosage of B is correctly determined, B does not require a price reduction. The average daily dosage of the respective drug in the TQV, which is decisive for the determination of the daily therapy costs, is to be determined in the cascade model, i.e. primarily on the basis of the recommended initial / maintenance dosage according to the technical information. In the absence of such an exact specification, the mean value of the dose range is to be considered.

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