ibrutinib (Imbruvica) MCL

following a full submission assessed under the end of life and ultra-orphan medicine processes:

ibrutinib (Imbruvica®) is accepted for use within NHS Scotland.

Indication under review: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

In a randomised, open-label, phase III study ibrutinib significantly prolonged progression-free survival, the primary endpoint, compared to a chemotherapy treatment, in patients with relapsed or refractory MCL.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ibrutinib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

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