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Market Access Alerts >December 2021>Germany
New HTA Decisions in Germany
December 2021
Drug name
KLISYRI® (tirbanibulin (actinic keratosis))
Company
Almirall Hermal GmbH
Decision date
01/12/2021
About PHMR
Therapeutic area
Skin conditions
Therapeutic sub area
Skin conditions: general and other
G-BA decision date
15/02/2022
Orphan Drug?
No
Decision
No additional benefit
Indication
Field therapy of non-hyperkeratotic, non-hypertrophic actinic keratoses (Olsen grade 1) on the face or scalp in adults. Appropriate comparator therapy: Diclofenac hyaluronic acid gel (3%), or 5-fluorouracil, or imiquimod, or cryotherapy in the treatment of single lesions.
Decision Detail
Main studies: KX01-AK-003 and KX01-AK-004 Main driver of decision: The studies presented by the company were not suitable for the benefit assessment; there were no relevant studies identified for comparative therapy.
Summary
IQWIG concluded that there was no added benefit.


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