following a full submission assessed under the end of life and orphan medicine process:
venetoclax (Venclyxto®) is accepted for use within NHS Scotland.
Indication under review: as monotherapy for the treatment of chronic lymphocytic leukaemia (CLL):
- in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
- in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
In phase II, non-comparative studies of patients with relapsed / refractory CLL, treatment with venetoclax was associated with clinically meaningful overall response rates.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of venetoclax. 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.
Download detailed advice295KB (PDF)
Medicine details
- Medicine name:
- venetoclax (Venclyxto)
- SMC ID:
- 1249/17
- Indication:
- as monotherapy for the treatment of chronic lymphocytic leukaemia (CLL): in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
- Pharmaceutical company
- AbbVie Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 07 August 2017