following a full submission assessed under the orphan equivalent medicine process:
ibrutinib (Imbruvica®) is accepted for use within NHSScotland.
Indication under review: in combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
In a phase III study, ibrutinib plus venetoclax resulted in a statistically significant improvement in progression-free survival compared with another combination therapy in a defined group of patients with previously untreated CLL.
This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was based, or PAS/ list prices that are equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
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Medicine details
- Medicine name:
- ibrutinib (Imbruvica)
- SMC ID:
- SMC2543
- Indication:
In combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- Pharmaceutical company
- Janssen-Cilag Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 11 September 2023
SMC was made aware of an error in the original version on this advice: the dosing escalation of venetoclax was incorrectly described in section 1.1 and table 2.1 and incorrect costs calculated in table 9.1. Please destroy any copies of the original advice and use the amended version, re-issued October 2023.