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    Has all of the relevant evidence been taken into account?

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Draft guidance consultation

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1 Recommendations

1.1 Zanubrutinib is not recommended, within its marketing authorisation, for treating chronic lymphocytic leukaemia (CLL) in adults.

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

The treatment options are different for untreated CLL (with or without a 17p deletion or tumour protein 53 [TP53] mutation), and for relapsed or refractory CLL. There are no clinical trials comparing zanubrutinib with several relevant comparator treatments. Also, the results of trials that are available with some of the currently used treatments are uncertain.

The main conclusions are that:

  • The company's submission did not include evidence for people with untreated CLL for whom fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine plus rituximab (BR) is suitable. Because FCR or BR suitability criteria are not used in clinical practice, this could potentially create an equality issue by denying younger and fitter people access to a new treatment option.

  • The SEQUOIA trial is applicable to people regardless of suitability for FCR or BR, so providing analysis for everyone with untreated CLL would address the equality issue.

  • In untreated CLL, venetoclax-based regimens are used so should be included.

  • In relapsed or refractory CLL, venetoclax plus rituximab is used so should be included.

Because of the uncertainty in the clinical- and cost-effectiveness evidence for zanubrutinib in all CLL populations, the cost-effectiveness estimates for zanubrutinib are highly uncertain. So, it is not recommended.