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.
Medicine details
- Medicine name:
- ibrutinib (Imbruvica)
- SMC ID:
- SMC2387
- Indication:
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.
- Pharmaceutical company
- Janssen-Cilag Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 13 December 2021