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    Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Ibrutinib is not recommended, within its marketing authorisation, for treating Waldenstrom's macroglobulinaemia in adults who have had at least 1 prior therapy.

1.2 This recommendation is not intended to affect treatment with ibrutinib that was funded by the Cancer Drugs Fund before final guidance was published. If this applies, when that funding ends ibrutinib will be funded by the company until the patient and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for ibrutinib for treating Waldenstrom's macroglobulinaemia in adults who have had at least 1 prior therapy (NICE technology appraisal guidance 491)

Ibrutinib is the only licensed treatment for Waldenstrom's macroglobulinaemia. Usually, the condition is treated with chemoimmunotherapy. The new evidence includes data from clinical trials and from people having treatment in the NHS via the Cancer Drugs Fund. It shows that ibrutinib improves how long people live before their condition gets worse and how long they live for. But, it is uncertain by how much it does this compared with chemoimmunotherapy.

The cost-effectiveness estimates for ibrutinib are higher than what NICE usually considers a cost-effective use of NHS resources. Therefore, it is not recommended.