Faricimab (2) – Vabysmo®
Neovascular age-related macular degeneration (AMD)
Characteristics
| Start date | 15.10.2022 – Marketing authorisation: 15.09.2022 |
|---|---|
| Resolution | 06.04.2023 |
| INN | Faricimab |
| Brand name | Vabysmo® |
| Pharm. company | Roche Pharma AG |
| G-BA Procedure ID | D-886 |
| ATC code | S01LA09 Antineovascularisation agents (S01LA) |
| ICD-10 codes (AIS) | H35.30Age-related macular degeneration |
| Alpha-ID codes (AIS) | I129318Age-related wet macular degeneration |
| Therapeutic area | Eye diseases Age-related macular degeneration (AMD) |
| Reason for procedure | Initial assessment |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Vabysmo is used to treat adult patients with neovascular (wet) age-related macular degeneration (nAMD). |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with neovascular (wet) age-related macular degeneration (nAMD) | Ranibizumab or aflibercept |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (TENAYA, LUCERN) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT (off-label)) |
- Clinical trials
- The pharmaceutical manufacturer identifies the two randomised controlled trials (RCTs), TENAYA and LUCERNE, within the indicated therapeutic indication.
- Both studies are double-blind, multicentre RCTs comparing faricimab with aflibercept in patients aged 50 years and over with neovascular age-related macular degeneration.
Adults with neovascular (wet) age-related macular degeneration (nAMD)
- For adults with neovascular (wet) age-related macular degeneration (nAMD), the additional benefit of faricimab is not proven.
- No evaluable data are available for assessing the additional benefit of faricimab compared with the appropriate comparator therapy.
- As neither of the two studies provided for the flexibility permitted under the SmPC for aflibercept, and given the resulting imbalance between the treatment arms, both studies are excluded from this benefit assessment in accordance with the pharmaceutical manufacturer’s approach as set out in the dossier.
- Overall assessment
- An additional benefit of faricimab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Faricimab (3) | Vabysmo® | Roche Pharma AG | Macular oedema due to retinal vein occlusion | 59,200–96,400 | 100% additional benefit not proven | |
| Faricimab (2) | Vabysmo® | Roche Pharma AG | Neovascular age-related macular degeneration (AMD) | 85,200–681,400 | 100% additional benefit not proven | |
| Faricimab (1) | Vabysmo® | Roche Pharma AG | Diabetic macular edema (DME) | 190,000–241,000 | 100% additional benefit not proven |
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