1 Recommendations

1.1 Zanubrutinib is recommended as an option for treating Waldenstrom's macroglobulinaemia in adults who have had at least 1 treatment, only if:

  • bendamustine plus rituximab is also suitable and

  • 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

Standard care for Waldenstrom's macroglobulinaemia varies but typically includes chemoimmunotherapy combinations such as bendamustine plus rituximab, or dexamethasone plus rituximab and cyclophosphamide. When chemoimmunotherapy is unsuitable, rituximab or chlorambucil alone are typically offered.

Clinical evidence from an indirect comparison suggests that people with Waldenstrom's macroglobulinaemia may live longer and have a better quality of life with zanubrutinib than with standard care. Long-term evidence on the effectiveness of zanubrutinib is not yet available. So, it is unclear how much longer people having zanubrutinib live.

For people who have had previous treatment, the cost-effectiveness estimates for zanubrutinib are only within what NICE usually considers an acceptable use of NHS resources when bendamustine plus rituximab is also suitable. Zanubrutinib is recommended for this group. For people who have not had previous treatment and if chemoimmunotherapy is unsuitable, the cost-effective estimates for zanubrutinib are above what NICE usually considers an acceptable use of NHS resources. Zanubrutinib is not recommended for this group.

  • National Institute for Health and Care Excellence (NICE)