Indication, Classification and Reimbursement

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A breakthrough* in chemotherapy for high-risk AML patients1

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)2

  • WHO define specific AML disease entities based on clinical features, morphology, cytogenetics and molecular genetics to define disease entities of clinical significance3
  • t-AML and AML-MRC are distinct subcategories with high-risk features5
  • Up to a third of AML patients may fall into these high-risk categories6,7

VYXEOS LIPOSOMAL REIMBURSEMENT STATUS IN THE UK

NICE guidance8
Liposomal cytarabine–daunorubicin is recommended, within its marketing authorisation, as an option for untreated therapy-related acute myeloid leukaemia or acute myeloid leukaemia with myelodysplasia-related changes in adults. It is recommended only if the company provides it according to the commercial arrangement8

    SMC advice9
    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 NHS Scotland9
    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 regimen9
    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 lower9

      ADVERSE EVENTS REPORTING

      Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions. Reporting forms and information can be found at https://yellowcard.​mhra.​gov.​uk/. Adverse events should also be reported by email to AEreporting@jazzpharma.com or by fax to +44 (0) 1865 598765.

      UK-VYX-2000050 | June 2020