Here are the latest G-BA decisions from the G-BA meeting held on 6 November 2025 on the early benefit assessments of Rinvoq, Prevymis, and Columvi.
A database of all previous G-BA resolutions is available in my store.
- Rinvoq (Upadacitinib); new indication: giant cell arteritis – Hint of minor additional benefit in one of two subgroups
- Prevymis (Letermovir); new indication:
- CMV reactivation/disease, prophylaxis after stem cell transplantation, < 18 years, ≥ 5 kg – Orphan drug, exceeding annual sales of €30mn, Hint of not-quantifiable additional benefit
- CMV disease, prophylaxis after kidney transplantation, < 18 years, ≥ 40 kg – Orphan drug, exceeding annual sales of €30mn, Additional benefit not proven
- Columvi (Glofitamab)
- diffuse large B-cell lymphoma (DLBCL), after ≥ 2 prior therapies – Removal of orphan drug status as regulatory level, Additional benefit not proven in both subgroups
- new indication: relapsed or refractory diffuse large B-cell lymphoma, in combination with gemcitabine and oxaliplatin, not suitable for autologous stem cell transplantation – Additional benefit not proven in all 3 subgroups
- Rezurock (Belumosudil); chronic graft-versus-host disease – Request for RWE data collection removed, no restriction of prescribing
- Jaypirca (Pirtobrutinib); relapsed or refractory mantle cell lymphoma – Request for RWE data collection
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