ibrutinib (Imbruvica)

following a full submission assessed under the orphan medicine process:

ibrutinib (Imbruvica®) is accepted for restricted use within NHSScotland.

Indication under review: in combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia.

SMC restriction: for use in patients who have received at least one prior therapy.

Progression-free survival was longer in patients with Waldenström's macroglobulinaemia who received ibrutinib plus rituximab compared with placebo plus rituximab in a phase III study.

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

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.