Last Review Date: 07/05/2023

Date of Origin: 08/29/2017

Dates Reviewed: 08/2017, 07/2018, 07/2019, 07/2020, 09/2020, 04/2021, 07/2022, 07/2023

I. Length of Authorization

• Coverage will be provided for a maximum of 2 cycles of induction (6 doses total) and 2 cycles of consolidation (4 doses total) within 6 months. Coverage may not be renewed.

II. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Vyxeos single-dose vial: 26 vials total

2. Max Units (per dose and over time) [HCPCS Unit]:

• Induction/Re-Induction (Second Induction): 132 billable units per dose (3 vials per dose; 6 doses total)
• Consolidation: 88 billable units per dose (2 vials per dose; 4 doses total)

III. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 1 year of age (unless otherwise specified); AND
• Baseline left ventricular ejection fraction (LVEF) is within normal limits and will be reassessed prior to consolidation and as clinically required; AND
• Cumulative lifetime anthracycline (e.g., daunorubicin, etc.) dose does not exceed 550 mg/m² (or 400 mg/m² in patients who received radiation to the mediastinum); AND
• Will not be used in combination with other chemotherapy; AND

Acute Myeloid Leukemia (AML) † ‡ Ф ^1-3

• Patient has one of the following sub-types of disease:
  • Therapy-related acute myeloid leukemia (t-AML)
  • AML with myelodysplasia-related changes (AML-MRC)
  • Antecedent myelodysplastic syndrome/chronic myelomonocytic leukemia (antecedent MDS/CMML) (Note: For antecedent MDS/CMML, use is only allowed in patients age ≥ 60 years of age that are candidates for intensive induction therapy); AND
• Used for one of the following:
  • Used as induction therapy for newly diagnosed disease; OR
  • Used as re-induction therapy after standard-dose cytarabine induction therapy ‡; AND
    • Used in patients with significant residual disease in the absence of hypocellular marrow and core binding factor (CBF) abnormalities; OR
  • Used as consolidation therapy

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria ^1,3

Authorizations may not be renewed.

V. Dosage/Administration ^1,3

VI. Billing Code/Availability Information

HCPCS Code:

• J9153 - Injection, liposomal, 1 mg daunorubicin and 2.27 mg cytarabine; 1 billable unit = 1 1 mg daunorubicin and 2.27 mg cytarabine

NDC:

• Vyxeos (44 mg daunorubicin and 100 mg cytarabine) liposome, single-dose vial: 68727−0745­­−xx

VII. References

1. Vyxeos [package insert]. Palo Alto, CA; Jazz Pharmaceuticals, Inc., September 2022. Accessed June 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for cytarabine/daunorubicin liposome. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed June 2023.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Acute Myeloid Leukemia. Version 3.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed June 2023.
4. Lin TL, Ryan RJ, Fadert S, et al. Outcomes in older patients with high-risk/secondary AML who achieved remission with CPX-351 versus 7+3 but did not undergo transplant: Phase 3 exploratory analysis. J Clin Onco; DOI: 10.1200/JCO.2020.38.15_suppl.7537 Journal of Clinical Oncology38, no. 15_suppl(May 20, 2020)7537-7537.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A