11 December 2024 – In its decision of 26 November 2024, the Federal Administrative Court upheld the appeal of A. AG, the marketing authorization holder of B, which is included in the List of Pharmaceutical Specialties (Spezialitätenliste, SL) in four different forms and sizes. The appellant had challenged the decision of the Federal Office of Public Health (FOPH), which determined that the cost-effectiveness as part of the triennial review should be assessed based on B.b. The appellant requested that the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV) should instead be conducted on B.a., as B.a. has an additional active ingredient, the therapeutic value of which had not been adequately considered.

The FOPH defended its decision by stating that, in the absence of an adequate comparison based on both the main indication and the smallest pack size of B, the TQV had to be carried out based on the package with the highest sales volume. However, the court criticized that it was unclear how the FOPH had identified the package with the highest sales volume. The court refrained from further enquiries, since the case was to be referred back to the FOPH for the following reasons:

The appellant argued that B.a., due to its additional active ingredient, offered a therapeutic advantage over B.b. and therefore the TQV should have been conducted on B.a. The court recalled its established practice that the basis for the relevant comparison is not the nature and quantity of the active ingredient, but the indication or similar mode of action. The court found that B.a. and B.b. could no longer be considered to be the same medicinal product due to the different composition of the active ingredients and the approved indications. Despite the deviation from the provisions of the List of Pharmaceutical manual, the FOPH should therefore have considered whether a separate review or classification of B.b. and B.a. was justified.

The court also criticized the FOPH for not adequately considering the study presented by the appellant, which demonstrated the added value of B.a. over B.b. This study should have been included in the assessment of the TQV and the price reduction. However, the FOPH had failed to incorporate this new evidence into its decision, leading to an erroneous evaluation of the effectiveness and pricing.

The court therefore referred the case back to the FOPH for it to set the prices of B.a. and B.b. anew, following clarification and re-examination in line with the considerations.

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