venetoclax (Venclyxto)

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.