ibrutinib (Imbruvica)

following a full submission under the orphan medicine process:

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

Indication under review: as a single agent 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.

SMC restriction: for use in patients who have received at least one prior therapy.
In a phase II study, in previously treated patients with Waldenström’s macroglobulinaemia, ibrutinib was associated with an overall response rate of 87% to 90%.

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.