Federal Administrative Court, Decision C-6116/2018 of 22 September 2021

15 October 2021 – The court had to examine whether the price reduction ordered in the context of the triennial review of the admission conditions of a medicinal product on the list of pharmaceutical specialities was lawful. The issue was in particular whether the methods used to determine whether the medicinal product is economical, namely the APV and TQV, were correct and lawful. With regards to the APV, the Court reaffirmed its current practice and accepted that an APV was conducted despite the fact that there was only one reference country. With regards to the TQV, the court held that the Federal Office of Public Health (FOPH) had wrongly deviated from the SmPC using off-label dosages. Moreover, the dosage used by the FOPH did not correspond to the dosage used in outpatient treatment, which, in practice, represents the main use of the medicinal product in question, but rather to the dosage used in stationary treatment. Consequently, the FOPH had used a wrong average dosage for the calculation of the daily therapy costs. The court concluded that the price reduction was neither based on a TQV carried out in accordance with the law nor based on a factual situation that had been clarified in a legally acceptable manner. Therefore, the court annulled the ruling and referred the case back to the lower instance.

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