Advice

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

liposomal formulation of daunorubicin/cytarabine (Vyxeos®) is accepted for use within NHSScotland.

Indication under review: The treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes.In a randomised phase III study, in adults (aged 60 to 75 years) with high risk AML, liposomal daunorubicin/cytarabine improved overall survival when compared with a standard of care regimen.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of liposomal daunorubicin/cytarabine. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.

Medicine details

Medicine name:
liposomal formulation of daunorubicin & cytarabine (Vyxeos)
SMC ID:
SMC2130
Indication:
Treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AMC-MRC)
Pharmaceutical company
Jazz Pharmaceuticals
BNF chapter
Malignant disease and immunosuppression
Submission type
Full
Status
Accepted
Date advice published:
11 March 2019