19.5.2026
SL Insight Newsletter #35
TQV comparator only when the treatment goals are the same
Marcel Boller
In its ruling C-3838/2023 of March 3, 2026, the Federal Administrative Court overturned a decision by the Federal Health Authority regarding the triennial review of the drug Relaxane® and determined that the conditions for a price reduction had not been met.
What are the key points?
- The Federal Administrative Court overturns the TQV conducted by the Federal Office of Public Health (FOPH) regarding a drug whose indication text overlaps verbatim with that of the drug under review
- A “genuine therapeutic alternative” requires a comprehensive assessment of the therapeutic goal, composition, mechanism of action, and clinical use. The wording of the prescribing information is not sufficient
What does this mean in practice?
For marketing authorization holders, this opens up an additional line of defense in TQV disputes, particularly in cases where a comparator drug formally covers the same indication but is, in practice, used for a different therapeutic purpose. The requirement to consider the overall picture shifts the burden of proof significantly toward the Federal Health Authority (BAG).
