Facts
A. GmbH is the marketing authorisation holder of the medicinal product B., approved by Swissmedic, which is listed on the Specialties List (SL) and contains the active ingredient C.
The Federal Office of Public Health (FOPH) subjected B. to a reassessment as part of the triennial review of the SL listing conditions. A. GmbH proposed D., E., F., G. and H. as comparator products. Undisputed were the reference medicinal products as well as the average doses of D., E., F. and G. Remaining in dispute were the average dose of B. and H. and the pack size of H. to be used.
By decision of 21 September 2018, the FOPH determined a reduction rate of -27.7743335% (TQV of -24.3724854%, foreign price comparison of -31.233726%) and reduced the public prices.
The Federal Administrative Court dismissed the appeal by judgment of 20 August 2020 and, after threatening a reformatio in peius, reduced the public prices once more. A. GmbH filed a public law appeal with the Federal Supreme Court and requested the annulment of the lower court's judgment and of the decision; alternatively, remittal for recalculation.
The dispute concerned in particular whether the TQV of B. for B. and H. is to be based on the average maintenance doses derived from the dose range (mean value) or on the usual dose recommended in the specialist information.
Considerations
The Federal Supreme Court notes that under Art. 65b para. 4bis lit. b HIO the TQV is to be carried out on the basis of the average daily therapy costs of the average maintenance doses of the medicinal products to be compared. The parties to the proceedings agree that cost-effectiveness is to be assessed on the basis of a foreign price comparison (APV) and a TQV.
A valid Swissmedic authorisation is a necessary but not sufficient condition for SL listing. Since the SL authorisation may not extend further in terms of indications than the authorisation under medicinal products law, the FOPH must rely on the Swissmedic authorisation or the specialist information (referring to BGE 143 V 369 consid. 6 and BGE 147 V 194 consid. 5.3.1). Treatment recommendations of medical specialist societies that do not reflect the current state of knowledge and deviate from the specialist information are not determinative.
The Federal Supreme Court clarifies the so-called cascade model of the FOPH: where precise dosage instructions can be taken from the specialist information, these are to be used. If the specialist information contains a clear statement on the recommended or usual dosage, this is to be used as the basis for the TQV. Where precise information is lacking, the entire dose range is to be taken into account and its mean value used, unless direct comparative studies exist. Where no information at all is available, equivalent doses from guidelines, clinical studies or foreign authorisation documents may be drawn upon. It is decisive that the dosages for all medicinal products…