Facts
The case concerns the pricing of the patent-protected pharmaceutical B., which is indicated for the treatment of (...). B. was classified as a follow-on product without therapeutic progress compared to the original product D. already listed in the Speciality List (SL). According to Art. 65b(6) HIO, the costs for research and development must be taken into account in the assessment of the cost-effectiveness of an original product, unless it is a follow-on product without therapeutic progress. In this case, the therapeutic cross-comparison (TCC) is carried out with non-patent-protected comparator products.Considerations
The Federal Supreme Court confirms that Art. 65b(6) HIO also applies within the framework of the three-yearly review of the admission conditions pursuant to Art. 65d HIO. This provides a sufficient legal basis to make the consideration of patent protection or the costs for research and development in the TCC of a follow-on product dependent on the existence of a therapeutic progress.
The Federal Supreme Court considers the classification of B. as a follow-on product without therapeutic progress compared to D. to be in accordance with federal law. Neither the higher bioavailability, the possibility of fine titration in 5 mg steps, nor the patented M. technology demonstrate a clinically relevant additional…