Decision 9C_162/2023 of 12 March 2024

5 avril 2024 – In its decision of 12 March 2024, the Federal Supreme Court upheld the appeal of Grünenthal Pharma AG, the marketing authorization holder of the medicinal product Transtec Transdermal (following: Transtec) against the decision of the Federal Administrative Court and the decision of the Federal Office of Public Health (FOPH) concerning the triennial review of the admission requirements regarding the List of Pharmaceutical Specialties (Spezialitätenliste, SL).

The question in dispute was whether the Federal Administrative Court had violated federal law by upholding FOPH's decision to reduce the price of Transtec. It was recognised that Transtec holds a valid authorisation from Swissmedic and that Transtec continues to fulfil the criteria of efficacy and appropriateness as part of the triennial review and that its cost-effectiveness is to be assessed, among other things, on the basis of a comparison with the price in reference countries (Auslandpreisvergleich, APV), which also did not lead to any objections.

However, the size of the package of the comparator medicinal product "Durogesic" that should be used as the basis for the therapeutic cross comparison (Therapeutischer Quervergleich, TQV) was disputed. The court at first stated that the TQV must be carried out on the basis of the smallest package and dosage, unless the smallest package and dosage do not allow an adequate comparison, in particular due to different dosages at the start of therapy or different packaging sizes (Art. 65d para. 3 Ordinance on Health Insurance (Verordnung über die Krankenversicherung, KVV)). The court held that this exception applied: An adequate comparison between the two smallest packages and dosages of the medicinal products was objectively not indicated, since the lowest dosage strength of Durogesic (12 mcg/h) was only used for titration and therefore has no analgesic equipotency compared to Transtec (35 mcg/h). The court concluded that the TQV of Transtec has to be carried out with the reference product Durogesic, based on the equianalgesic dose ratio between 35 mcg/h transdermal buprenorphine and 25 mcg/h + 12 mcg/h transdermal fentanyl.

The concrete mathematical determination of the reduction rate, as carried out by the appellant, has not led to any criticism from any side. As there are no indications of any shortcomings in this respect, the price of CHF 62.51 resulting from the TQV and APV calculated in this way must be accepted. This price is higher than Transtec's current factory price (FAP) of CHF 59.62, which is why the latter proves to be economical. A price reduction was therefore out of the question for the court.

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