Federal Administrative Court, Decision C-6892/2019 from 28 October 2021

12. November 2021 – In its decision, the Court had to decide whether the lower instance was obliged to carry out the TQV of a medicinal product with a product from another range (gammenübergreifend) or whether the lower instance was correct by saying that the medicinal product in question did not constitute a therapy alternative. In the case at hand the Court held that based on the SmPC, no oral treatment was possible for the comparator medicinal product (powder for the preparation of an infusion solution), while for the medicinal product under assessment it was possible to switch from intravenous treatment to oral therapy if there is a clear clinical improvement. Thus, it can be concluded that the comparator medicinal product did not represent an alternative therapy. The court further rejected the alleged contradictions to therapy guidelines or studies and violation of the principle of equal treatment as argued by the appellant.

However, the Court held that if, as in the present case, no patent-expired comparator medicinal product is available for the TQV, the lower court cannot refrain from including a patent-protected medicinal product if it represents an available alternative therapy. As such an alternative therapy was available for the medicinal product in question, the exclusion of said product from the TQV solely on the basis of patent protection and the consequential waiver of a TQV was not in conformity with federal law.

The court concluded that the price reduction was not based on a lawful examination of the economical character of the medicinal product in question since a TQV should have been carried out. Therefore, the court annulled the ruling and referred the case back to the lower instance.

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