How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, sex, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Zanubrutinib for treating Waldenstrom's macroglobulinaemia

Closed for comments This consultation ended on at   Request commenting lead permission

1 Recommendations

1.1 Zanubrutinib is not recommended, within its marketing authorisation, for treating Waldenstrom's macroglobulinaemia in adults after at least 1 therapy or as first-line treatment when chemoimmunotherapy is unsuitable.

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 monotherapy are typically offered. Ibrutinib is available for people with previously-treated Waldenstrom's macroglobulinaemia via the Cancer Drugs Fund. However, because it is not approved for routine commissioning in the NHS, it could not be considered in this appraisal.

Clinical evidence suggests that people with Waldenstrom's macroglobulinaemia may live longer and have a better quality of life with zanubrutinib than with standard care. However, the results are uncertain because zanubrutinib has only been indirectly compared with standard care, and there is no clinical evidence directly comparing zanubrutinib with usual NHS treatments. Also, long-term evidence on the effectiveness of zanubrutinib is not yet available. So, it is unclear how much longer people having zanubrutinib live.

The most likely cost-effectiveness estimate for zanubrutinib is higher than what is normally considered a cost-effective use of NHS resources. So, zanubrutinib cannot be recommended.