ibrutinib (Imbruvica)

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

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

Indication under review: the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

SMC restriction: patients with relapsed/refractory CLL and for whom fludarabine-based regimens are inappropriate.

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.

This resubmission relates to use as a single agent for the treatment of adult patients with CLL who have received at least one prior therapy. SMC published advice in August 2016 that ibrutinib was accepted for restricted use as a single agent for patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy (SMC 1151/16).