Here are the G-BA decisions from the G-BA meeting held on 21 December 2023 on the early benefit assessments of Yescarta, Bimzelx, Adempas, Koselugo, and Opdivo.
A complete database of all previous G-BA resolutions is available through my membership.
- Yescarta (axicabtagene ciloleucel); re-assessment of an orphan drug after exceeding the €30mn threshold: diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma, after at least 2 previous therapies – Additional benefit not proven
- Yescarta (axicabtagene ciloleucel); new indication, orphan drug exceeding the €30mn threshold: follicular lymphoma, after ≥ 3 previous therapies – Additional benefit not proven
- Yescarta (axicabtagene ciloleucel); new indication, orphan drug exceeding the €30mn threshold: Diffuse large B-cell lymphoma, high-grade B-cell lymphoma, after 1 previous therapy, relapse within 12 months or refractory – Hint of not-quantifiable additional benefit
- Bimzelx (bimekizumab); new indication: axial spondyloarthritis, non-radiographic – Additional benefit not proven
- Bimzelx (bimekizumab); new indication: Ankylosing spondylitis – Additional benefit not proven
- Bimzelx (bimekizumab); new indication: psoriatic arthritis, monotherapy or in combination with methotrexate – Additional benefit not proven
- Adempas (riociguat); new indication: pulmonary arterial hypertension, patients aged < 18 years – Additional benefit not proven
- Koselugo (selumetinib); orphan drug, re-assessment after expiry of time restriction: neurofibromatosis: patients aged ≥ 3 to < 18 years, type 1 – Hint of not-quantifiable additional benefit
- Opdivo (nivolumab); new indication: melanoma, adjuvant therapy, adolescents aged ≥ 12 to 18 years, monotherapy – Additional benefit not proven
- Opdivo (nivolumab); new indication: melanoma, adolescents aged ≥ 12 to 18 years, monotherapy or combination with ipilimumab – Additional benefit not proven in both subgroups
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