Vyxeos Liposomal is indicated for the treatment of adults with newly-diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)1
World Health Organization use clinical features, morphology, cytogenetics and molecular genetics to define AML disease entities of clinical significance2
t-AML and AML-MRC are distinct subcategories with high-risk features4
Up to a third of AML patients may fall into these high-risk categories5,6
VYXEOS LIPOSOMAL REIMBURSEMENT STATUS IN THE UNITED KINGDOM
National Institute for Health & Care Excellence (NICE) guidance7
Liposomal cytarabine–daunorubicin is recommended, within its marketing authorisation, as an option for untreated t-AML or AML-MRC in adults. It is recommended only if the company provides it according to the commercial arrangement7
Scottish Medicines Consortium (SMC) advice8
Advice: Following a full submission assessed under the end of life and ultra-orphan medicine process, liposomal formulation of daunorubicin/cytarabine (Vyxeos Liposomal) is accepted for use within National Health Service (NHS) Scotland8
Indication under review: The treatment of adults with newly-diagnosed, t-AML or AML-MRC. In a randomised Phase 3 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 regimen8
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 NHS Scotland or a list price that is equivalent or lower8
In February 2021, the Health Service Executive (HSE) approved for reimbursement Vyxeos Liposomal 44 mg/100 mg powder for concentrate for solution for infusion (daunorubicin and cytarabine): “For the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)”9,10
*High-risk AML is defined as therapy-related AML or AML with myelodysplasia-related changes.
AML, acute myeloid leukaemia; MDS, myelodysplastic syndrome; MRC, myelodysplasia-related changes; NHS, National Health Service; NICE, National Institute for Health & Care Excellence; PAS, Patient Access Scheme; SMC, Scottish Medicines Consortium; t-AML, therapy-related AML.