In its judgment, the Federal Administrative Court (the Court) upheld the appeal of Santen SA against the Federal Office of Public Health (FOPH) and referred the matter back to the FOPH for a fresh, comprehensive economic assessment and a new decision. At issue was the price reduction ordered for the ophthalmic combination product Cosopt (dorzolamide and timolol) in the 2022 triennial review of the admission conditions for the List of Pharmaceutical Specialties (Spezialitätenliste, SL), and in particular the composition of the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV) group.

The FOPH had reduced the public price of Cosopt on the basis of a foreign price comparison (Auslandpreisvergleich, APV), which was not disputed, and a TQV conducted against the mono-preparations Trusopt and Timoptic, on the reasoning that a combination product should not cost more than the combination of the corresponding mono-preparations. In the course of the proceedings, the FOPH reconsidered its decision to remove a generic from the comparison, following the Federal Supreme Court's case law that generics may not be included in the TQV, but maintained the comparison with the two mono-preparations. Santen argued that the fixed combination should instead be compared with other combination products, chiefly Azarga (as in the 2019 review) and possibly Combigan, since the mono-preparations did not constitute a genuine therapy alternative.

The Court held that, under settled case law, the decisive criterion for the TQV was not the type and quantity of active substance but whether the comparator was a genuine, full and equivalent therapy alternative that was actually interchangeable in clinical practice. On the basis of the product information and the studies on file, including the European Glaucoma Society guidelines, it found substantial indications that, in everyday clinical use, a fixed combination was preferred to the separate administration of two mono-preparations, in particular because the required ten-minute interval between drops was rarely observed, adherence was better with a simpler regimen, and the risk of a wash-out effect and of contamination was lower. The FOPH had failed to investigate whether the mono-preparations were in fact prescribed as a genuine therapy alternative, had not addressed whether Cosopt was a second-line treatment not comparable with first-line mono-preparations, had not carried out the required weighing of interests when departing from its 2019 selection of comparators, and had relied on a circular whose approach it had itself since abandoned. As the relevant facts had not been established, the Court annulled the contested decisions and remitted the case.

For more information, see here.