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New HTA Decisions in Germany
December 2021
Drug name
JEMPERLI® (dostarlimab)
Company
GlaxoSmithKline GmbH & Co. KG
Decision date
02/12/2021
Therapeutic area
Cancer
Therapeutic sub area
Endometrial cancers
G-BA decision date
02/12/2021
Orphan Drug?
No
Decision
No additional benefit
Indication
Adult patients with recurrent or advanced endometrial cancer, with mismatch repair deficiency/high microsatellite instability, that is progressive during or after previous treatment with a platinum based therapy. Appropriate comparator therapy: Therapy as prescribed by a doctor.
Decision Detail
Main studies: GARNET, ZotpEC and study registry 216960. Main driver of decision: The company presented subsequent data adjusted for potential confounders. In both of the indirect comparisons submitted, no sufficient structural equality of the treatment groups was achieved by the adjustment carried out. The confounder adjustment was insufficient for the benefit assessment.
Summary
In this addendum to commission, the decision of no added benefit made by IQWiG in September 2021 (original benefit assessment A21-84) was unchanged. The G-BA supported the decision made by IQWiG.