Log in or register to see all Alerts
New HTA Decisions in England
December 2020
Drug name
VENCLYXTO® (venetoclax)
Company
Abbvie
Decision date
10/11/2020
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Decision
Recommended with restrictions (CDF)
Indication
Venetoclax plus obinutuzumab is recommended as an option for untreated chronic lymphocytic leukaemia (CLL) in adults.
Decision Detail
Venetoclax plus obinutuzumab is recommended as an option for untreated chronic lymphocytic leukaemia (CLL) in adults, only if: • there is a 17p deletion or TP53 mutation, or; • there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR), is unsuitable, and; • the companies provide the drugs according to the commercial arrangements (simple discount patient access schemes). Venetoclax plus obinutuzumab is recommended for use within the Cancer Drugs Fund as an option for untreated CLL in adults, only if: • there is no 17p deletion or TP53 mutation, and FCR or BR is suitable, and; • the conditions in the managed access agreement for venetoclax plus obinutuzumab are followed.
Summary
The company presented results from CLL14, an open-label randomised controlled trial comparing venetoclax plus obinutuzumab with obinutuzumab plus chlorambucil. Clinical trial evidence shows that, in people without a 17p deletion or TP53 mutation and for whom FCR or BR is unsuitable, CLL treated with venetoclax plus obinutuzumab takes longer to progress than CLL treated with obinutuzumab plus chlorambucil. The cost-effectiveness estimates suggest that venetoclax plus obinutuzumab is more effective and less costly than obinutuzumab plus chlorambucil. Therefore, venetoclax plus obinutuzumab is recommended for routine use in the NHS for these people. Venetoclax plus obinutuzumab has not been directly compared with FCR or BR in people without a 17p deletion or TP53 mutation and for whom these treatments are suitable. The results of an indirect comparison are uncertain. Also, some of the cost-effectiveness estimates are higher than the range NICE normally considers an acceptable use of NHS resources. Therefore, venetoclax plus obinutuzumab cannot be recommended for routine use in the NHS for these people. Venetoclax plus obinutuzumab has the potential to be a cost-effective use of NHS resources. Therefore, it is recommended for use in the Cancer Drugs Fund for these people while the data from the trial are collected.