1 Recommendations

1.1

Zanubrutinib is recommended as an option for treating chronic lymphocytic leukaemia (CLL) in adults. It is only recommended if the CLL is:

untreated and
- there is a 17p deletion or tumour protein 53 (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, or
relapsed or refractory.

Zanubrutinib is recommended only if the company provides it according to the commercial arrangement.

1.2

This recommendation is not intended to affect treatment with zanubrutinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Usual treatments are different for untreated CLL and for relapsed or refractory CLL. For untreated CLL with a 17p deletion or TP53 mutation (high-risk CLL) treatments include acalabrutinib, ibrutinib and venetoclax-based treatments. For untreated CLL without a 17p deletion or TP53 mutation (non-high-risk CLL) when FCR or BR is unsuitable treatments include acalabrutinib and venetoclax-based treatments. For relapsed or refractory CLL usual treatments include acalabrutinib, ibrutinib and venetoclax plus rituximab.

Clinical trial evidence suggests that zanubrutinib extends the length of time people have before their condition gets worse compared with BR and ibrutinib in untreated CLL and relapsed or refractory CLL respectively. But there are no clinical trials comparing it with other CLL treatments and the results of indirect comparisons are uncertain.

For untreated CLL, despite the uncertainty, zanubrutinib is only cost effective or cost saving compared with usual treatments in high-risk CLL, or for non-high-risk CLL when FCR or BR is unsuitable. So, it is only recommended in these populations.

For people with relapsed or refractory CLL, despite the uncertainty, zanubrutinib is cost effective or cost saving compared with the usual treatments. So, it is recommended in this population.