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Zanubrutinib for treating Waldenstrom's macroglobulinaemia

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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:

  • they would otherwise have treatment with bendamustine and rituximab

  • the company provides it according to the commercial arrangement (see section 2).

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 and rituximab, or dexamethasone, 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.

The cost-effectiveness estimates are within what NICE usually considers an acceptable use of NHS resources in people who have had at least 1 treatment, but only if they would otherwise have bendamustine and rituximab. So, zanubrutinib is recommended for this group. The company did not submit any evidence for the initial treatment of Waldenstrom's macroglobulinemia with zanubrutinib compared with alternative therapies in people for who chemoimmunotherapy is unsuitable. So, no recommendation could be made for this group.