Decision C-271/2021 of 5 February 2024

8 marzo 2024 – against the decision of the Federal Office of Public Health (FOPH) against A. AG, the marketing authorization holder, concerning the triennial review of medicinal products Ba., Bb. and Bc.’s prices in the List of Pharmaceutical Specialties (Spezialitätenliste, SL).

B. is a patent-protected original preparation. It was undisputed that B. met the first two of the criteria of efficacy, appropriateness and cost-effectiveness (Kriterien der Wirksamkeit, Zweckmässigkeit und Wirtschaftlichkeit, WZW criteria). The application of the therapeutic cross-comparison (Therapeutischer Quervergleich, TQV) was disputed, in particular the TQV comparison grouping. The FOPH had excluded G. as a comparator medicinal product because it was a successor product of another comparator medicinal product (E.) and therefore no price was available before patent expiry. The marketing authorization holder, on the other hand, argued that it was not stated anywhere which preparations were successor preparations and that from a medical point of view, it was also incomprehensible that G. should not offer any therapeutic advantages over the comparator product E. (referring to Art. 65 para. 6 of the Ordinance on Health Insurance (Verordnung über die Krankenversicherung, KVV)).

The Federal Administrative Court supported the practice of the FOPH to normally carry out the TQV of patent-protected originator products with patent-protected originator products only. The FOPH thus adopted the qualitative differentiation criteria set out in Art. 65b para. 6 KVV as criteria for the selection of comparator medicinal products for the TQV.

The court examined whether the FOPH was right to classify G. as a successor product without therapeutic progress within the meaning of Art. 65b para. 6 KVV. The court stated that there was in fact no legal definition for the term "successor product" within the meaning of Art. 65b para. 6 KVV. However, in view of the information for healthcare professionals regarding the identity of the active substance and indication of G. and the comparator medicinal product, as well as the marketing authorization of G. as a preparation with a known active pharmaceutical ingredient (Präparat mit bekanntem Wirkstoff, BWS), however, it was appropriate for the FOPH to consider G. as a successor preparation within the meaning of Art. 65b para. 6 KVV (referring to decision C-6593/2018 consid. 7.5).

Furthermore, the court examined whether the FOPH was right to assume that G. did not demonstrate therapeutic progress within the meaning of Art. 65b para. 6 KVV compared to the comparator medicinal product E. previously listed in the SL. The court held that, contrary to the opinion of the FOPH, G. did not have to show a significant

therapeutic advance over the comparator drug E. In addition to statistical significance, however, the clinical significance is also relevant. A treatment can bring about statistically significant changes without these being clinically relevant (for example, if the improvements are too small). The court looked at the relevant studies and confirmed an actual therapeutic progress of G. Thus, G. is a patent-protected originator product which represents a successor product with a therapeutic advantage over E. Thus, according to Art. 65b para. 6 KVV, the costs for research and development are to be considered for G. - as for the medicinal product B. under review.

Finally, the court examined whether G. should be used as B.'s comparator drug and answered this question in the affirmative. The TQV of B. therefore had to be carried out with G. The court therefore upheld the appeal in part and instructed the FOPH to adapt the authorisation conditions and to issue a new decision.

For more information, see here.