Venetoclax plus obinutuzumab can be used, within its marketing authorisation, as an option for untreated chronic lymphocytic leukaemia (CLL) in adults. It can only be used if the companies provide the technologies according to the commercial arrangements.
What this means in practice
Venetoclax plus obinutuzumab must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. Venetoclax plus obinutuzumab must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that venetoclax plus obinutuzumab provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Why the recommendation was made
This evaluation partially reviews the evidence for venetoclax plus obinutuzumab for untreated CLL. It reviews new evidence collected for the population in the managed access agreement for NICE technology appraisal guidance 663. This includes evidence from clinical trials and from people having the treatment through managed access in the Cancer Drugs Fund in England.
Usual treatment for the population in the managed access agreement is venetoclax plus ibrutinib. Venetoclax plus obinutuzumab has not been directly compared in a clinical trial with venetoclax plus ibrutinib. But indirect comparisons suggest that they are likely to work as well as each other.
There are some uncertainties in the clinical evidence, which make the cost-effectiveness evidence uncertain. But the cost-effectiveness evidence suggests that venetoclax plus obinutuzumab has similar or lower costs than venetoclax plus ibrutinib.
In NICE technology appraisal guidance 663, NICE considered venetoclax plus obinutuzumab to be cost effective for the population outside the managed access agreement.
So, venetoclax plus obinutuzumab can be used for untreated CLL.
For all the evidence, see the committee papers for this evaluation and the committee papers for NICE technology appraisal guidance 663.
For more information on streamlined evaluations, see NICE's manual on health technology evaluations.