Astellas Pharma Ltd., the holder of the Swiss marketing authorisation for Prograf (oral capsules used for immunosuppression after organ transplants), challenged a Federal Office of Public Health (FOPH) decision to reduce the prices of Prograf following a triennial review under the List of Pharmaceutical Specialties (Spezialitätenliste, SL) framework. The FOPH based its price reduction on a therapeutic cross-comparison (Therapeutischer Quervergleich, TQV) with comparator drugs, notably using dosing data for Envarsus derived from indications concerning therapy switching, rather than from the main indication for de novo renal transplant recipients. Astellas lodged an appeal before the Federal Administrative Court, claiming the FOPH’s reliance on switch-dosing information was legally and scientifically flawed.

The Court underlined that, pursuant to Swiss statutory and regulatory provisions, price reviews for medicines in the List of Pharmaceutical Specialties must be thorough, notably incorporating an assessment of therapeutic and economic comparability between relevant drugs based on their principal indications. The Court stressed that where clear maintenance dose information for the main indication is lacking in the product information, reference must be made to robust clinical studies rather than to dosing ratios for therapy conversion. The Court found that the dosing language in the Envarsus product information, particularly in relation to switching from Prograf or Advagraf, was non-binding and insufficiently precise to determine the standard maintenance dose for the purposes of the therapeutic cross-comparison. It further noted that two independent studies cited by Astellas Pharma Ltd. contradicted the 30% dose-reduction assumption applied by the FOPH, instead indicating a much narrower dose difference. The Court criticised the FOPH for failing to perform supplementary clarifications regarding the actual average maintenance dose for Envarsus in the main indication and for relying on a less representative, narrower patient subset. Consequently, the underlying price reduction was deemed to rest on an inadequately established factual basis and a legally defective therapeutic cross-comparison.

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