Efbemalenograstim alfa (1) – Ryzneuta®
Febrile neutropenia due to chemotherapy
Characteristics
| Start date | 01.08.2024 |
|---|---|
| Resolution | 02.10.2024 |
| INN | Efbemalenograstim alfa |
| Brand name | Ryzneuta® |
| Pharm. company | Evive Biotech |
| G-BA Procedure ID | D-1097 |
| ATC code | L03AA18 Colony stimulating factors (L03AA) |
| Therapeutic area | Oncological diseases Febrile neutropenia |
| Reason for procedure | Initial assessment |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Ryzneuta is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy Neutropenia in adult patients treated with cytotoxic chemotherapy for malignant disease (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
Colony-stimulating factors, pegylated, Group 1, at Level 2
- The legal consequence of the company’s decision not to submit a dossier at the relevant time is a finding that the additional benefit is not proven.
- The pharmaceutical manufacturer has not claimed any therapeutic improvement, including due to minor side effects, or pharmacological-therapeutic non-comparability.
- In its deliberations on the determination of additional benefit for efbemalenograstim alfa and on the update, including the renaming of the fixed-amount group ‘Colony-stimulating factors, pegylated, Group 1’ to Tier 2, concluded that the additional benefit of efbemalenograstim alfa is deemed not proven in accordance with Section 35a(1), fifth sentence, of Book V of the Social Code (SGB V).
Courtesy translation only, please refer to the German original.
Associated procedures
| Efbemalenograstim alfa (1) | Ryzneuta® | Evive Biotech | Febrile neutropenia due to chemotherapy | n.d. | 100% additional benefit not proven |
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