Here are the G-BA decisions from the G-BA meeting held on 20 June 2024 on the early benefit assessments of Jemperli, Ayvakyt, Keytruda, Polivy, Yorvipath, Jardiance, and Libmeldy.
There was the rare occurrence of a major additional benefit – this is only the 12th time this highest rating was awarded.
A complete database of all previous G-BA resolutions is available upon request.
- Jemperli (dostarlimab); new indication: primary advanced or recurrent endometrial carcinoma with dMMR/ MSI-H, in combination with carboplatin and paclitaxel – Indication of major additional benefit in one of two subgroups
- Ayvakyt (avapritinib); new indication: indolent systemic mastocytosis (ISM) – Orphan drug, Indication of minor additional benefit
- Keytruda (pembrolizumab); new indications:
- biliary tract tumours, first line, in combination with gemcitabine and cisplatin – Indication of minor additional benefit
- adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2+, first line, in combination with trastuzumab and fluoropyrimidine and platinum-based chemotherapy – Additional benefit not proven
- adenocarcinoma of the stomach or gastroesophageal junction, PD-L1 expression ≥ 1, HER2-, first line, in combination with fluoropyrimidine and platinum-based chemotherapy – Additional benefit not proven
- Polivy (polatuzumab vedotin); re-assessment of an orphan drug after exceeding > €30 million sales threshold:
- diffuse large B-cell lymphoma, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHP); first line – Additional benefit not proven
- recurrent or refractory diffuse large B-cell lymphoma, in combination with rituximab and bendamustine – Additional benefit not proven across all 3 subgroups
- Yorvipath (palopegteriparatide); chronic hypoparathyroidism, parathyroid hormone (PTH) replacement therapy – Orphan drug, manufacturer requested full assessment – Additional benefit not proven
- Jardiance (empagliflozin); new indication: diabetes mellitus type 2, patients aged ≥ 10 to ≤ 17 years; combination therapy – Additional benefit not proven
- Libmeldy (atidarsagen autotemcel); metachromatic leukodystrophy with biallelic mutation in the ARSA gene – Restriction of previous decision extended until 1 July 2026
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