Brolucizumab (1) – Beovu®
Neovascular age-related macular degeneration
Characteristics
| Start date | 15.03.2020 – Marketing authorisation: 13.02.2020 |
|---|---|
| Resolution | 03.09.2020 repealed |
| Limitation date | 01.11.2023 |
| INN | Brolucizumab |
| Brand name | Beovu® |
| Pharm. company | Novartis Pharma GmbH |
| G-BA Procedure ID | D-514 |
| ATC code | S01LA06 Antineovascularisation agents (S01LA) |
| ICD-10 codes (AIS) | H35.30Age-related macular degeneration |
| Alpha-ID codes (AIS) | I129318Age-related wet macular degeneration |
| DDD | 0.04 U IVT |
| Therapeutic area | Eye diseases Age-related macular degeneration (AMD) |
| Reason for procedure |
Initial assessment
Repealed by: Brolucizumab (3) (02.05.2024) |
| Therapeutic indication of the resolution |
|---|
|
Beovu is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with neovascular (wet) age-related macular degeneration | Ranibizumab oder Aflibercept |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
- Clinical trials
- The pharmaceutical manufacturer identifies five randomised controlled trials (RCTs) comparing brolucizumab with aflibercept or ranibizumab: SEE (C-10-083), OSPREY (C-12-006), HAWK (RTH258-C001), HARRIER (RTH258-C002) and TALON (CRTH258A2303).
- The double-blind RCT SEE, with a study duration of 6 months, compared brolucizumab with ranibizumab.
- In the OSPREY, HAWK and HARRIER studies, brolucizumab was compared with aflibercept.
Adults with neovascular (wet) age-related macular degeneration
- For adults with neovascular (wet) age-related macular degeneration, the additional benefit is not proven.
- The additional benefit of brolucizumab compared with the appropriate comparator therapy is therefore not proven.
- Consequently, in none of the identified studies was the appropriate comparator therapy used in accordance with the SmPC, meaning that no data are available from which the additional benefit of brolucizumab compared with ranibizumab or aflibercept can be derived.
Courtesy translation only, please refer to the German original.
Associated procedures
| Brolucizumab (3) | Beovu® | Novartis Pharma GmbH | Neovascular age-related macular degeneration | 85,200–681,400 | 100% additional benefit not proven | |
| Brolucizumab (2) | Beovu® | Novartis Pharma GmbH | Diabetic macular edema | 190,000–241,000 | 100% additional benefit not proven | |
| Brolucizumab (1) | Beovu® | Novartis Pharma GmbH | Neovascular age-related macular degeneration |
0
85,200–681,400 |
100% additional benefit not proven repealed |
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