Advice

following a full submission assessed under the end of life and orphan equivalent medicine process:

venetoclax (Venclyxto ®) is accepted for use within NHSScotland.

Indication under review: in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.

In a phase III study, treatment with venetoclax in combination with azacitidine significantly improved overall survival and remission rate when compared with azacitidine alone.

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.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
venetoclax (Venclyxto)
SMC ID:
SMC2412
Indication:

In combination with a hypomethylating agent (HMA) for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy (IC).

Pharmaceutical company
AbbVie Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published
11 April 2022