Here are the latest G-BA decisions from the G-BA meeting held on 21 August 2025 on the early benefit assessments of Beyfortus, Andembry, Darzalex, Blincyto, Imcivree, Inrebic, Obgemsa, Aquipta, and Fabhalta – quite a mixed bag. The G-BA accepted an ITC and an evidence transfer from older to younger children!
A database of all previous G-BA resolutions is available in my store.
- Beyfortus (nirsevimab); dossier required for first time: prevention of RSV disease, children during their first RSV season who are not addressed in the RSV antibody treatment information – Indication of considerable additional benefit
- Andembry (garadacimab) hereditary angioedema, prophylaxis, ≥ 12 years – Hint of considerable additional benefit, based on indirect treatment comparison
- Darzalex (daratumumab); reassessment after expiry of previous resolution: systemic light chain amyloidosis, first-line, in combination with cyclophosphamide, bortezomib, and dexamethasone, subgroup of patients for whom Vcd is most appropriate therapy – Orphan drug, exceeding €30mn annual sales threshold – Hint of considerable additional benefit
- Blincyto (blinatumomab); new indication:
- Acute lymphocytic B-cell leukemia, Ph-, CD19+, newly diagnosed – Orphan drug, Hint of considerable additional benefit
- Acute lymphocytic B-cell leukemia, high-risk first relapse, Ph-, CD19+, ≥ 1 month and < 1 year – Orphan drug, Hint of not-quantifiable additional benefit, evidence transfer accepted
- Acute lymphocytic B-cell leukemia, relapsed/refractory, ≥ 1 month to < 1 year, after ≥ 2 prior therapies or after allogeneic stem cell transplantation – Orphan drug, Hint of not-quantifiable additional benefit
- Imcivree (setmelanotide); new indication: obesity and hunger control, POMC, PCSK1, LEPR deficiency, or Bardet-Biedl syndrome, ≥ 2 to < 6 years – Orphan drug, Hint of not-quantifiable additional benefit
- Inrebic (fedratinib), reassessment after expiry of previous resolution: myelofibrosis – Orphan drug, Hint of not-quantifiable additional benefit
- Obgemsa (vibegron) overactive bladder – Additional benefit not proven
- Aquipta (atogepant) migraine prophylaxis – Additional benefit not proven in both subgroups
- Fabhalta (iptacopan); new indication: complement 3 glomerulopathy – Orphan drug, discontinuation of the benefit assessment, since €30mn annual sales threshold was exceeded and full assessment is required
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