Ixekizumab (4) – Taltz®
Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg
Characteristics
| Start date | 01.08.2020 – Marketing authorisation: 26.06.2020 |
|---|---|
| Resolution | 21.01.2021 |
| INN | Ixekizumab |
| Brand name | Taltz® |
| Pharm. company | Lilly Deutschland GmbH |
| G-BA Procedure ID | D-570 |
| ATC code | L04AC13 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | L40.0Nummular psoriasis |
| Alpha-ID codes (AIS) | I109655Plaque psoriasis |
| DDD | 2.9 mg P |
| Therapeutic area | Skin diseases Plaque psoriasis (PP) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children and adolescents aged 6 years and older with moderate to severe chronic plaque psoriasis and a body weight of at least 25 kg who are eligible for systemic therapy. | Adalimumab or etanercept or ustekinumab |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: Evidence transfer) |
Children and adolescents aged 6 years and over with moderate to severe chronic plaque psoriasis and a body weight of at least 25 kg, who are eligible for systemic therapy
- For children and adolescents aged 6 years and over with moderate to severe chronic plaque psoriasis and a body weight of at least 25 kg who are eligible for systemic therapy, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
- In its overall assessment, the G-BA therefore concludes that, for children and adolescents with moderate to severe plaque psoriasis, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
- Overall assessment
- On balance, the G-BA therefore concludes that, for children and adolescents with moderate to severe plaque psoriasis, the additional benefit of ixekizumab compared with the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Ixekizumab (6) | Taltz® | Lilly Deutschland GmbH | Enthesitis-associated arthritis, ≥ 6 years | 240–290 | 100% additional benefit not proven | |
| Ixekizumab (5) | Taltz® | Lilly Deutschland GmbH | Juvenile psoriatic arthritis, aged ≥ 6 years | 120–180 | 100% additional benefit not proven | |
| Ixekizumab (4) | Taltz® | Lilly Deutschland GmbH | Plaque psoriasis (PP), ≥ 6 to < 18 years, body weight ≥ 25 kg | 270–2,035 | 100% additional benefit not proven | |
| Ixekizumab (3) | Taltz® | Lilly Deutschland GmbH | Axial spondyloarthritis | 36,300 | 100% additional benefit not proven | |
| Ixekizumab (2) | Taltz® | Lilly Deutschland GmbH | Psoriatic arthritis (PA) | 29,100 | 35% Hint for minor additional benefit | |
| Ixekizumab (1) | Taltz® | Lilly Deutschland GmbH | Plaque psoriasis (PP) | 52,200–234,400 | 55% Indication of considerable additional benefit |
<< List of all resolutions