The National Institute for Health and Care Excellence (NICE) has published draft guidance that does not recommend venetoclax (Venclyxto, AbbVie) within its marketing authorisation for treating chronic lymphocytic leukaemia.

The independent appraisal committee agreed that there were substantial shortcomings in the clinical effectiveness evidence presented by the company, meaning that the treatment benefits of venetoclax were uncertain.

Clinical and cost effectiveness 

The incremental cost-effectiveness ratios (ICERs) for venetoclax compared with best supportive care were higher than the normally range considered cost-effective for use in the NHS.

Venetoclax is licensed for the treatment of adults with chronic lymphocytic leukaemia in the presence of a 17p deletion or TP53 mutation, who are unsuitable for, or whose disease has progressed after a B-cell receptor pathway inhibitor, and in the absence of a 17p deletion or TP53 mutation in people whose disease has progressed after both chemo-immunotherapy and a B-cell receptor pathway inhibitor.

Future decisions

The draft recommendations are now out for public consultation, and comments received during this time will be considered by the committee.