16. November 2020 – In a recent decision, the Federal Administrative Court held that the lower instance in the context of the three-yearly price review may choose to deviate from the selection of the reference products made at the time of the new admission, if it can provide significant factual reasons for doing so and if the principle of legality is to be given higher weight than the protection of the legitimate expectations. Since extemporaneous preparations are not listed in the specialities list and are therefore not intended for therapeutic cross-comparisons (TCC), the lower court was allowed to deviate from the selection of the reference products made at the time of the new admission. Furthermore, the Federal Administrative Court held that the inclusion of a pharmaceutical product in the TCC does not require absolute identity with the product under review and that it does not prevent a pharmaceutical product from being taken into account if it has an indication which goes beyond that of the product under review.

The Federal Administrative Court subsequently stated that a pharmaceutical product is to be classified as a second-line medicinal product only if, according to the professional information, it is only used if the treatment with another preparation fails, is not tolerated or cannot be considered for other reasons.

Finally, the Federal Administrative Court held that the principle that, wherever possible, preparations with identical product range affiliation must be compared under the TCC does not preclude the use of a preparation assigned to another product range in an individual case if it can be classified as an alternative method of equivalent value. The appeal is dismissed.

For the full decision, see here.