Federal Administrative Court, Decision C-358/2019 of 30 December 2020

22 January 2021 – In a recent decision concerning the three-yearly price review, the Federal Administrative Court examined whether the Federal Office of Public Health (FOPH) used the correct comparative products when assessing the cost-effectiveness of a medicinal product. In this regard, it held that the assessment of the comparability of the medicinal products pursuant to Art. 65b Health Insurance Ordinance (KVV) must generally be based on the wording of the authorization of the medicinal product by Swissmedic or the corresponding professional information. The Federal Administrative Court also discussed the discretionary power of the FOPH and held that the FOPH is free to include only those medicinal products from the set of comparative medicinal products for the therapeutic cross comparison (TQV) that show a solid ratio between the medical benefit and the costs. The FOPH does not have to include all comparative medicinal products and can in particular exclude medicinal products with above-average costs in order to prevent a high price level. Considering this, the court determined that the FOPH had not abused its discretion and dismissed the complaint.

For the full decision see here.