Last Review Date: 07/02/2024

Date of Origin: 08/29/2017

Dates Reviewed: 08/2017, 07/2018, 07/2019, 07/2020, 09/2020, 04/2021, 07/2022, 07/2023, 07/2024

1. Length of Authorization

• Coverage will be provided for a maximum of 2 cycles of induction (5 doses total) and 2 cycles of consolidation (4 doses total) within 6 months. Coverage may not be renewed.

2. Dosing Limits

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

• Vyxeos single-dose vial: 23 vials total

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

• 1012 billable units per 155 days

3. 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 therapy-related acute myeloid leukemia (t-AML) OR AML with myelodysplasia-related changes (AML-MRC) †; AND
  • Used as induction therapy for newly diagnosed disease; OR
  • Used as re-induction therapy after cytarabine-based induction therapy; OR
  • Used as consolidation therapy; OR
• Patient has antecedent myelodysplastic syndrome/chronic myelomonocytic leukemia (antecedent MDS/CMML) ‡; AND
  • Patient is at least 18 years of age; AND
    • Used as induction therapy for patients who are candidates for intensive induction therapy; OR
    • Used as re-induction therapy after cytarabine-based induction therapy; AND
      • Patient has residual disease; OR
    • Used as consolidation therapy; OR
• Patient has poor-risk AML with and without TP53-mutation or del17p abnormality ‡; AND
  • Patient is at least 18 years of age; AND
  • Used as consolidation therapy

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

4. Renewal Criteria ^1,3

Authorizations may not be renewed.

5. Dosage/Administration ^1,3

6. 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

7. References

1. Vyxeos [package insert]. Palo Alto, CA; Jazz Pharmaceuticals, Inc., September 2022. Accessed May 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for cytarabine/daunorubicin liposome. National Comprehensive Cancer Network, 2024. 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 May 2024.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Acute Myeloid Leukemia. Version 3.2024. National Comprehensive Cancer Network, 2024. 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 May 2024.
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)

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

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