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.
- Medicine name:
- ibrutinib (Imbruvica)
- SMC ID:
In combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinaemia.
- Pharmaceutical company
- Janssen-Cilag Ltd
- Submission type
- Date advice published
- 12 October 2020