venetoclax (Venclyxto)

following a full submission:

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).

SMC restriction: in patients without del (17p)/TP53 mutation who are fit to receive fludarabine, cyclophosphamide and rituximab (FCR) chemo-immunotherapy.

Venetoclax in combination with obinutuzumab, compared with standard therapies, was associated with clinical benefits in patients who were fit and unfit to receive FCR chemo-immunotherapy.

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.

For SMC advice relating to the use of venetoclax in (1) patients without del (17p)/TP53 mutation who are not fit to receive FCR chemo-immunotherapy and (2) patients with del (17p)/TP53 mutation, please refer to SMC2293.