In new draft guidance, NICE approves first-line venetoclax plus obinutuzumab for untreated chronic lymphocytic leukaemia (CLL).
The new fixed 12-month chemotherapy-free treatment will be offered to adults with untreated CLL, 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 company provides the drug according to the commercial arrangement.
The draft guidance also recommends venetoclax plus obinutuzumab for use within the Cancer Drugs Fund as an option for untreated CLL in adults, if there is no 17p deletion or TP53 mutation, and FCR or BR is suitable.
Venetoclax plus obinutuzumab has not been directly compared with ibrutinib in people with a 17p deletion or TP53 mutation, and the results of an indirect comparison have proved uncertain. The cost-effectiveness estimates suggest venetoclax plus obinutuzumab is less effective but less costly than ibrutinib. The estimates were within NICE’s normal range, so it is recommended for routine use for these patients.
Clinical trial evidence shows that, in people without a 17p deletion or TP53 mutation and for whom FCR or BR is unsuitable, the combination is associated with longer progression-free survival (PFS) compared with obinutuzumab plus chlorambucil. The cost-effectiveness estimates suggest venetoclax plus obinutuzumab is more effective and less costly than obinutuzumab plus chlorambucil. Therefore, it is recommended for routine use in these patients.
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 were uncertain and some of the cost-effectiveness estimates were above the threshold NICE considers an appropriate use of NHS resources. Therefore, NICE does not recommend this treatment for routine use for these people.
An ongoing clinical trial is directly comparing venetoclax plus obinutuzumab with FCR and BR in people with untreated CLL without a 17p deletion or TP53 mutation. NICE believes the combination has the potential to be cost-effective. Therefore, it is recommended for use in the Cancer Drugs Fund for these people while data are collected.
