3.9.2025
SL Insight Newsletter #5
No TQV possible? - SNB allows APV-only, stops price reduction.
Werder Viganò
The Federal Administrative Court (C-146/2022, 28.07.2025) sets clear limits for the TQV in 3-year reviews: Only SL-listed originator products may be used as a comparison - extemporaneous preparations (and generics) are out.
What did the court actually decide?
If there is no suitable SL comparator preparation, the TQV does not apply. The court has excluded extemporaneous preparations from the TQV. Cost-effectiveness is assessed solely by APV. The old manual practice (non-SL comparisons) is no longer permitted according to the court. The 37.8% price reduction ordered by the FOPH in the 2018 review was subsequently revoked by the court. Despite the higher APV, the prices remain unchanged, as an increase is excluded on the basis of Art. 65d para. 4 KVV.
Takeaway:
Inreviews without a real SL alternative, the marketing authorization holder can actively defend against TQV comparisons with magistrals/generics and demand APV-only. The ruling is thus direct ammunition against overly broad comparator groups - particularly relevant for pediatric, orphan and niche drugs.
