ibrutinib (Imbruvica) CLL

following a full submission assessed under the end of life and orphan medicine process:

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

Indication under review: treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

SMC restriction: patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy.

In an open-label, phase III study, ibrutinib significantly increased progression-free survival compared with an anti-CD20 antibody in patients with relapsed or refractory CLL.

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.

The license holder has indicated their intention to resubmit for relapsed or refractory disease.