INDICATION, CLASSIFICATION AND REIMBURSEMENT

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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

        ADVERSE EVENTS REPORTING

        Adverse events should be reported. Reporting forms and information for the UK can be found at https://yellowcard.mhra.gov.uk/

        For Ireland, reporting forms and information can be found at: www.hpra.ie

        Adverse events should also be reported to Jazz Pharmaceuticals at AEreporting@jazzpharma.com

        IE-VYX-2100004 l March 2021