Federal Administrative Court, Decision C-7133/2017 of 16 February 2021

5. März 2021 – In this decision, the Federal Administrative Court examined the three-yearly price review of a medicinal product. The appellant argued that the Federal Supreme Court in decision BGE 142 V 26 obliged the Federal Office of Public Health (FOPH) to no longer exclude the decisive element of "therapeutic cross-comparison" in the periodic review of the cost-effectiveness pursuant to art. 32 para 2 Federal Health Insurance Act (KVG). According to the criteria set out in the leading decision, the "principle of main indication" applied by the lower court in the present case did not stand up to federal law because only a "cranked" TQV was carried out by the FOPH. As a result, for all indications other than the main indication of a multi-indication preparation, changes in the specialities list (SL) were completely disregarded from an economic point of view; in other words, the pricing of a multi-indication preparation disregarded any examination of the economic viability of other indications. In any case, the interpretation made by the FOPH in its administrative ordinance did not comply with the legal requirements and the opinion of the Federal Supreme Court. The FOPH has no discretion in this matter, as this would require the underlying legal provisions to be correspondingly open, which is not the case here with art.. 65d para 3 and art. 65b para 4bis Health Insurance Ordinance (KVV). After a detailed examination, the court concludes that the price reduction enacted by the FOPH is neither based on a TQV carried out in accordance with the law nor on facts that have been clarified by the law. The appeal was upheld.

For the full decision, see here.