2. Februar 2021 – In these decisions, 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 that was in dispute, but only the cost-effectiveness, or more precisely the calculation method used for the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV). The Federal Administrative Court dismissed the appeal and held that where precise dosage information can be found in the specialist information, on the basis of which the average daily therapy costs can be calculated, there is no room for a ‘practical assumption’ of the average daily therapy costs. Further, it is to be assumed that the usual or average dosage also represents the average values regarding the demand-based dosage instructions. Finally, the complainant argued that the decision was inappropriate because the medicinal product was listed in category D of the SL and, due to its very low price, was mainly financed privately. Hence, there would be no reason to relieve the health insurance fund by reducing the retail price. The court did not accept this argument either and pointed out that the complainant was free to have the medicinal product removed from the SL, which would result in free pricing for the complainant. However, as long as it is listed in the SL and thus reimbursed by the compulsory health insurance, the complainant must accept the price control by the FOPH.

For the full decision, see here (C-5583) and here (C-5886).