14. Oktober 2021 – In this case, the calculation of the therapeutic cross-comparison (TQV), but not that of the APV, was disputed. Previously, the Federal Office of Public Health (FOPH) had reduced the ex-factory price and the retail price of one of the appellant’s medications by -46.57%. The appellant appealed against this order of the FOPH and argued that the TQV of the FOPH was based on a selection of comparative preparations that was contrary to federal law as well as a selection of dose strength and package size that violated the law. The appellant was of the opinion that with the new version of the SL-manual, the FOPH had made a change in practice and that the comparator medicines included for the calculation of the TQV based on the epilepsy guideline did not represent a real therapy alternative.

The court did not see a change in practice with the new passage in the SL-Manual, which also permits medicines with additional, non-identical indications as reference medicines. However, according to the court, the preparation under review had two limitations of indications in different lines of therapy. Since a comparison of two medicinal products approved for different therapeutic lines was - if at all - only possible to a limited extent, a review of a medicinal product limited to the first-line therapy of a preparation, which also (or primarily) had an authorization for second-line therapy, could only be attributed a limited informative value. The complete disregard of the second-line therapy within the framework of the TQV in the present case meant that any changes in that therapeutic area or in that therapy line were not reviewed at all.

Additionally, two of the comparator medicines had side effects according to the expert information, so that they could not be used as a therapy alternative, according to the court.

In conclusion, the price reduction was neither based on a TQV carried out in accordance with the law, nor on facts that had been clarified in a legally sufficient manner. Thus, the court upheld the appeal, annulled the contested order by the FOPH and referred the matter back to the FOPH so that it can carry out a new TQV in the sense of the recitals, subsequently determine the price of the medication on the basis of this TQV, and issue a new order.

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