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New HTA Decisions in Germany
December 2021
Drug name
VENCLYXTO® (venetoclax)
AbbVie Deutschland GmbH & Co. KG
Decision date
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
G-BA decision date
Orphan Drug?
Considerable additional benefit
In combination with a hypomethylating substance in adult patients with newly diagnosed acute myeloid leukaemia, for whom intensive chemotherapy is not suitable. Appropriate comparator therapy: Cytarabine or azacitidine or decitabine.
Decision Detail
Main study: Viale-A Main drivers of decision: The decision of considerable added benefit for the indication in the original dossier assessment A21-82 was unchanged. The company presented subsequent evaluations for the morbidity endpoint transfusion independence based on event-time analyses. The subsequent analyses demonstrated an advantage of combined venetoclax for the endpoint transfusion independence, however, the data raised uncertainties with regards to validity of results and the operationalisation of the endpoint.
In this addendum to commission, the decision of considerable added benefit made by IQWiG in September 2021 (original assessment A21-82) was unchanged. The G-BA supported the decision made by IQWiG.