zanubrutinib (Brukinsa)

following a resubmission assessed under the orphan equivalent medicine process:

zanubrutinib (Brukinsa®) is accepted for use within NHSScotland.

Indication under review: as monotherapy for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

In a phase III study, there was no significant difference between zanubrutinib and a first-generation Bruton’s tyrosine kinase (BTK) inhibitor in the rates of patients achieving a complete response or very good partial response.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.