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Here are the key decisions made by the G-BA during its meeting on October 19, 2023, concerning the early benefit assessments of various medications:
1. Hemgenix (Etranacogene Dezaparvovec):
- Indication: Hemophilia B
- Orphan drug status
- The assessment suggests there may be an additional benefit, but it’s challenging to quantify.
2. Libtayo (Cemiplimab):
- New Indication 1: Cervical cancer in previously treated patients
- Considerable additional benefits were observed in one of the two subgroups.
3. Libtayo (Cemiplimab):
- New Indication 2: Non-small cell lung cancer, first-line treatment, PD-L1 expression ≥ 1%, in combination with platinum-based chemotherapy
- No additional benefit was demonstrated in either subgroup.
4. Rinvoq (Upadacitinib):
- New Indication: Crohn’s disease in previously treated patients
- No additional benefit was established in either subgroup.
5. Talvey (Talquetamab):
- Indication: Relapsed and refractory multiple myeloma after at least three previous therapies
- Request for real-world data collection and prescription restrictions.
6. Adakveo (Crizanlizumab):
- The decision was removed from the previous resolution dated May 20, 2021, due to the loss of marketing authorization.
These decisions provide insights into the assessment of various medications for different indications and patient groups. They consider additional benefits, real-world data collection, and prescription restrictions to ensure the appropriate use of these drugs in the German healthcare system. It’s important to note that the availability of a comprehensive database of all previous G-BA resolutions can be accessed through a membership, allowing for greater transparency and understanding of past decisions related to pharmaceuticals and healthcare in Germany.
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