Vyxeos (daunorubicin and cytarabine)

Indications for Prior Authorization

Vyxeos (daunorubicin and cytarabine)
  • For diagnosis of Newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
    Indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

Criteria

Vyxeos

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • One of the following diagnoses: [1-3]
    • Newly-diagnosed therapy-related acute myeloid leukemia (t-AML)
    • Newly-diagnosed acute myeloid leukemia with myelodysplasia-related changes (AML-MRC)
Vyxeos

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
P & T Revisions

2023-07-03, 2022-06-01, 2021-09-27, 2021-06-02, 2021-05-25, 2020-06-02

  1. Vyxeos Prescribing Information. Jazz Pharmaceuticals. Palo Alto, CA. April 2021.
  2. National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available by subscription at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed May 28,2021.
  3. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Acute Myeloid Leukemia v.3.2021. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/aml.pdf. Accessed May 28, 2021.

  • 2023-07-03: Removed specialist requirement
  • 2022-06-01: 2022 Annual Review - No changes to criteria
  • 2021-09-27: 2021 Annual Review. Updated indication section due to expanded approval to patients 1 year of age and older. No change to clinical criteria.
  • 2021-06-02: 2021 Annual Review. Updated indication section due to expanded approval to patients 1 year of age and older. No change to clinical criteria.
  • 2021-05-25: Addition of EHB formulary. No changes to criteria
  • 2020-06-02: Annual Review: updated references

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