1 Recommendations

1.1 Ibrutinib plus venetoclax is recommended, within its marketing authorisation, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. This is only if the companies provide both drugs according to the commercial arrangements.

Why the committee made this recommendation

Treatments for untreated CLL include acalabrutinib, fludarabine plus cyclophosphamide and rituximab (FCR), ibrutinib alone, obinutuzumab plus chlorambucil, and venetoclax plus obinutuzumab. FCR is rarely used in clinical practice.

Clinical evidence shows that CLL takes longer to get worse, and people live longer, when they have ibrutinib plus venetoclax compared with obinutuzumab plus chlorambucil. An indirect comparison with acalabrutinib, FCR, ibrutinib alone, and venetoclax plus obinutuzumab suggests that CLL takes longer to get worse when treated with ibrutinib plus venetoclax.

The cost-effectiveness estimates are within what NICE normally considers an acceptable use of NHS resources, so ibrutinib plus venetoclax is recommended.