Federal Administrative Court, Decision C-637/2018 of 15 February 2021

5 March 2021 – In this decision, a marketing authorisation holder appealed against the price reductions ordered by the Federal Office of Public Health (FOPH) as part of the periodic price review. It was not the medical authorisation itself that was in dispute, but only the cost-effectiveness, or more precisely the comparative products used for the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV). In this regard, the Federal Administrative Court 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. The appellant also argued that he had been treated unequally compared to a competitor. Thus, in the TQV of a similar medicinal product of his competitor, a certain medicinal product had been included which had not been considered within the context of the three-yearly price review of his product. After a detailed examination, the court did not accept this argument either and determined that the FOPH had not abused its discretion. The appeal was dismissed.

For the full decision, see here.