1.1
Zanubrutinib can be used as an option to treat relapsed or refractory mantle cell lymphoma in adults who have had 1 line of treatment only. Zanubrutinib can only be used if the company provides it according to the commercial arrangement.
1 Recommendations
1.2
Use the least expensive option of the suitable treatments (including zanubrutinib and ibrutinib), having discussed the advantages and disadvantages of the available treatments with the person with the condition. Take account of administration costs, dosages, price per dose and commercial arrangements.
1.3
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 healthcare professional consider it appropriate to stop.
What this means in practice
Zanubrutinib must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Zanubrutinib must be funded in England within 30 days of final publication of this guidance.
There is enough evidence to show that zanubrutinib 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 committee made these recommendations
Zanubrutinib is licensed for treating relapsed or refractory mantle cell lymphoma after at least 1 treatment. But for this evaluation, zanubrutinib was considered for treating relapsed or refractory mantle cell lymphoma after 1 line of treatment only.
Usual treatment for relapsed or refractory mantle cell lymphoma after 1 line of treatment is ibrutinib. Zanubrutinib works in a similar way to ibrutinib and would be offered to a similar population.
The clinical effectiveness evidence for zanubrutinib comes from 2 small studies in which zanubrutinib was not compared with any other treatments. These trials included people who had had 1 or more lines of treatment. Because the studies were small, all of the data was considered, but in line with the proposed positioning of zanubrutinib, data from people who had had only 1 line of treatment was given more weight.
The results from an indirect treatment comparison are uncertain because of differences between the people in the included trials for zanubrutinib and ibrutinib. But the results suggest that zanubrutinib is likely to work at least as well as ibrutinib in this population.
Evidence from a database review of US clinical practice also supports that zanubrutinib is likely to work as well as ibrutinib for treating relapsed or refractory mantle cell lymphoma after 1 line of treatment only.
There are uncertainties with the economic model, so the cost-effectiveness estimates are uncertain. But a cost comparison suggests that zanubrutinib has similar or lower costs to ibrutinib. So zanubrutinib can be used.
For all evidence, see the committee papers. For more information on NICE's evaluation of ibrutinib, see the committee discussion section in NICE's technology appraisal guidance on ibrutinib for treating relapsed or refractory mantle cell lymphoma.