Tildrakizumab (1) – Ilumetri®
Plaque psoriasis (PP)
Characteristics
| Start date | 15.11.2018 – Marketing authorisation: 17.09.2018 |
|---|---|
| Resolution | 02.05.2019 |
| INN | Tildrakizumab |
| Brand name | Ilumetri® |
| Pharm. company | Almirall Hermal GmbH |
| G-BA Procedure ID | D-410 |
| ATC code | L04AC17 Interleukin inhibitors (L04AC) |
| ICD-10 codes (AIS) | L40.0Nummular psoriasis |
| Alpha-ID codes (AIS) | I109655Plaque psoriasis |
| DDD | 1.2 mg P |
| Therapeutic area | Skin diseases Plaque psoriasis (PP) |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Ilumetri is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adult patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy in the context of initial systemic therapy. | Adalimumab or guselkumab or ixekizumab or secukinumab |
| b) | Adult patients with moderate to severe plaque psoriasis who have had an inadequate response to or have not tolerated systemic therapy. | Adalimumab or guselkumab or infliximab or ixekizumab or |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (P011) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + no ITC) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Patient eligibility |
| ACT change | 01.08.2018 – Fumarsäureester keine ZVT mehr - EBM |
- Clinical trials
- For patient population b), the pharmaceutical manufacturer presents the randomised, double-blind, active- and placebo-controlled trial P011.
a) Adult patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy as part of their initial systemic treatment.
- For adult patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy as part of their first-line systemic treatment, the additional benefit is not proven.
- The pharmaceutical manufacturer was unable to provide a direct comparative study of tildrakizumab versus the appropriate comparator therapy for patient population a).
- Overall, the pharmaceutical manufacturer has therefore not provided suitable data for assessing the additional benefit of tildrakizumab compared with the appropriate comparator therapy.
- Overall assessment
- On balance, therefore, an additional benefit is not proven.
b) Adult patients with moderate to severe plaque psoriasis who have responded inadequately to, or are intolerant of, systemic therapy.
- For adult patients with moderate to severe plaque psoriasis who have responded inadequately to, or are unable to tolerate, systemic therapy, the additional benefit is not proven.
- Overall, the pharmaceutical manufacturer has therefore not provided suitable data to assess the additional benefit of tildrakizumab compared with the appropriate comparator therapy.
- Overall assessment
- On balance, therefore, no additional benefit is proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tildrakizumab (1) | Ilumetri® | Almirall Hermal GmbH | Plaque psoriasis (PP) | 157,100–234,400 | 100% additional benefit not proven |
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