vp-0314
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Vyxeos® (daunorubicin and cytarabine – liposome) (Intravenous)

Policy Number: VP-0314

Last Review Date: 07/05/2022

Date of Origin: 08/29/2017

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

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. 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.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Vyxeos single-dose vial: 23 vials total
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • Induction: 132 billable units per dose (3 vials per dose; 5 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 18 years 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); AND
  • Used for one of the following:
    • Patient is at least 1 year of age with newly diagnosed disease (Note: For antecedent MDS/CMML, use is only allowed in patients age ≥ 60 years of age that are candidates for intensive remission induction therapy); OR
    • Used as re-induction therapy after standard-dose cytarabine induction therapy ; AND
      • Patients ≥ 60 years of age with residual disease; OR
      • Patients < 60 years of age with significant residual disease in the absence of  hypocellular marrow and core binding factor (CBF) abnormalities; OR
    • Used as post-remission therapy ; AND
      • Patients ≥ 60 years of age with complete response to previous intensive therapy; OR
      • Patients < 60 years of age with treatment-related disease other than core binding factor (CBF) and/or unfavorable cytogenetics and/or molecular abnormalities

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

Indication

Dose

t-AML, antecedent MDS/CMML & AML-MRC

First induction

  • daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 liposome intravenously days 1, 3 and 5

Second induction

  • daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 liposome intravenously days 1 and 3
    • Only for patients who fail to respond to the first induction cycle
    • May be administered 2 to 5 weeks after the first induction cycle if there was no unacceptable toxicity

Consolidation

  • daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 liposome intravenously days 1 and 3
    • Administer the first consolidation cycle 5 to 8 weeks after the start of the last induction cycle
    • Administer the second consolidation cycle 5 to 8 weeks after the start of the first consolidation cycle if there was no unacceptable toxicity or disease progression

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., March 2021. Accessed June 2022.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for cytarabine/daunorubicin liposome. National Comprehensive Cancer Network, 2022. 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 2022.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Acute Myeloid Leukemia. Version 12.2022. National Comprehensive Cancer Network, 2022. 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 2022.
  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

ICD-10

ICD-10 Description

C92.00

Acute myeloblastic leukemia not having achieved remission

C92.01

Acute myeloblastic leukemia in remission

C92.50

Acute myelomonocytic leukemia not having achieved remission

C92.51

Acute myelomonocytic leukemia in remission

C92.60

Acute myeloid leukemia with 11q23-abnormality not having achieved remission

C92.61

Acute myeloid leukemia with 11q23-abnormality in remission

C92.A0

Acute myeloid leukemia with multilineage dysplasia not having achieved remission

C92.A1

Acute myeloid leukemia with multilineage dysplasia in remission

C93.00

Acute monoblastic/monocytic leukemia not having achieved remission

C93.01

Acute monoblastic/monocytic leukemia in remission

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC