Tirbanibulin (1) – Klisyri®
Actinic keratosis (AK), Olsen grade I
Characteristics
| Start date | 01.09.2021 – Marketing authorisation: 16.07.2021 |
|---|---|
| Resolution | 17.02.2022 |
| INN | Tirbanibulin |
| Brand name | Klisyri® |
| Pharm. company | Almirall Hermal GmbH |
| G-BA Procedure ID | D-722 |
| ATC code | D06BX03 Other chemotherapeutics (D06BX) |
| ICD-10 codes (AIS) | D04.3Carcinoma in situ of skin of other and unspecified parts of face, D04.4Carcinoma in situ of skin of scalp and neck, L57.0Keratosis NOS |
| Alpha-ID codes (AIS) | I103914Carcinoma in situ of the facial skin n.c, I104168Non-melanoma carcinoma in situ of the scalp n.c, I6277Actinic keratosis |
| DDD | 1 T |
| Therapeutic area | Skin diseases Squamous cell carcinoma |
| Reason for procedure | Initial assessment |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults with non-hyperkeratotic, non-hypertrophic actinic keratoses (OlsenGrade I) on the face or scalp. | Diclofenac hyaluronic acid gel (3%) or 5 fluorouracil (5 FU) or (surgical) Cryotherapy in the treatment of single cell lesions. |
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) |
| ACT change | 15.02.2020 – Info aus Stellungnahmen Fachgesellschaften |
- Clinical trials
- The pharmaceutical manufacturer has submitted data from the two marketing authorisation trials, KX01-AK-003 and KX01-AK-004, in the dossier.
- These studies are randomised, double-blind Phase III trials with an identical study design, in which tirbanibulin was compared with an inactive vehicle.
Adults with non-hyperkeratotic, non-hypertrophic actinic keratoses (Olsen Grade I) on the face or scalp
- An additional benefit is not proven.
- Overall, the pharmaceutical manufacturer has therefore not provided any data relevant to the benefit assessment.
- No direct comparative studies of tirbanibulin against the appropriate comparator therapy are available.
- As neither study included an active comparison with the appropriate comparator therapy, they are not suitable for assessing the additional benefit of tirbanibulin.
- Furthermore, a study duration of 8 weeks is considered too short for the indication in question.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tirbanibulin (1) | Klisyri® | Almirall Hermal GmbH | Actinic keratosis (AK), Olsen grade I | 700,000–1,380,000 | 100% additional benefit not proven |
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