following a full submission considered under the orphan equivalent process:
venetoclax (Venclyxto®) is accepted for restricted use within NHSScotland.
Indication under review: In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Venetoclax-obinutuzumab, compared with chlorambucil-obinutuzumab, significantly improved progression-free survival in adults with CLL and co-morbidities.
SMC restriction: for use in (1) patients without del (17p)/TP53 mutation who are not fit to receive FCR (fludarabine, cyclophosphamide and rituximab) chemo-immunotherapy and (2) patients with del (17p)/TP53 mutation.
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.
- Medicine name:
- venetoclax (Venclyxto)
- SMC ID:
In combination with obinutuzumab (VenG) is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- Pharmaceutical company
- AbbVie Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Date advice published
- 07 December 2020