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Ryzneuta® (efbemalenograstim alfa-vuxw) (Subcutaneous)

Policy Number: VP-0741

 (Subcutaneous)

Last Review Date: 01/04/2024

Date of Origin: 01/04/2024

Dates Reviewed: 01/2024

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.

  1. Length of Authorization

Coverage will be provided for four months and may be renewed unless otherwise specified.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Ryzneuta 20 mg/mL prefilled syringe: 1 syringe per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 20 mg per 14 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

For PEEHIP Members Only

  • Fulphila (pegfilgrastim-jmdb) is the preferred product and all other long-acting gCSF products are non-preferred; if the request is for Neulasta/Neulasta OnPro Kit see requirements below. Patient must have tried and had an inadequate response or intolerance to, or a contraindication to Fulphila, attributable to the biosimilar formulation, prior to consideration of a non-preferred long-acting gCSF product; OR Patient is continuing treatment with a non-preferred long-acting gCSF product for an oncology indication; AND
    • The requested agent is the preferred pegfilgrastim containing agent; OR
    • The patient has tried and had an inadequate response to the preferred pegfilgrastim containing agent (medical records required); OR
    • The patient has an intolerance or hypersensitivity to the preferred agent that is NOT expected to occur with the requested agent (medical records required); OR
    • The patient has an FDA labeled contraindication to the preferred agent that is NOT expected to occur with the requested agent (medical records required); OR
    • If the requested agent is Neulasta or Neulasta Onpro Kit the following must apply:
      • The patient is unable to return to the clinic the day following chemotherapy OR lives in excess of 60 miles from the treatment facility; AND
  • All other precertification requirements outlined below apply

For Commercial Members Only

  • Fulphila (pegfilgrastim-jmdb) and Nyvepria (pegfilgrastim-apgf) are the preferred products. Patients currently on non-preferred therapies may complete their current course of treatment for the duration of the current precertification period; upon precertification renewal or restarting therapy, transition to a preferred product is required; AND
    • The requested agent is the preferred pegfilgrastim containing agent; OR
    • The patient has tried and had an inadequate response to TWO preferred pegfilgrastim containing agents (medical records required); OR
    • The patient has an intolerance or hypersensitivity to TWO preferred agents that is NOT expected to occur with the requested agent (medical records required); OR
    • The patient has an FDA labeled contraindication to ALL preferred agent that is NOT expected to occur with the requested agent (medical records required); OR
    • If the requested agent is Neulasta Onpro Kit BOTH of the following must apply:
      • The patient and the caregiver (if applicable) are unable to administer the injection; AND
      • The patient is unable to return to the clinic the day following chemotherapy; AND
  • All other precertification requirements outlined below apply
  • Patient is at least 18 years of age; AND
  • Will not be used for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation; AND
  • Patient does not have a history of serious allergic reactions to granulocyte stimulating factor products (e.g., pegfilgrastim, filgrastim, etc.); AND

Prophylactic use in patients with non-myeloid malignancy † ‡ 1-7,9,10,12,13,15,17,27-29

  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of greater than 20% §; OR
  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10% to 20% § AND one or more of the following co-morbidities:
  • Age >65 years receiving full dose intensity chemotherapy
  • Extensive prior exposure to chemotherapy
  • Previous exposure of pelvis, or other areas of large amounts of bone marrow, to radiation
  • Pre-existing neutropenia (ANC ≤ 1000/mm3)
  • Bone marrow involvement with tumor
  • Patient has a condition that can potentially increase the risk of serious infection (i.e., HIV/AIDS with low CD4 counts)
  • Recent surgery and/or open wounds
  • Poor performance status
  • Renal dysfunction (creatinine clearance <50 mL/min)
  • Liver dysfunction (elevated bilirubin >2.0 mg/dL)
  • Chronic immunosuppression in the post-transplant setting including organ transplant

Note: Dose-dense therapy, in general, requires growth factor support to maintain dose intensity and schedule. In the palliative setting, consideration should be given to dose reduction or change in regimen.

§Febrile neutropenia is defined as: 7

  • Temperature: a single temperature ≥38.3 °C orally or ≥38.0 °C over 1 hour; AND
  • Neutropenia: <500 neutrophils/mcL or <1,000 neutrophils/mcL and a predicted decline to ≤500 neutrophils/mcL over the next 48 hours

§ Expected incidence of febrile neutropenia percentages for myelosuppressive chemotherapy regimens can be found in the NCCN Hematopoietic Growth Factors Clinical Practice Guideline at NCCN.org 7

FDA-Approved Indication(s); Compendium Recommended Indication(s); Ф Orphan Drug  

  1. Renewal Criteria 1

Coverage may be renewed based on the following criteria:

  • Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include:  splenic enlargement/rupture, acute respiratory distress syndrome, severe hypersensitivity reactions/anaphylaxis, severe sickle cell crises in patients with sickle cell disease, glomerulonephritis, hematologic effects (e.g., leukocytosis, thrombocytopenia), capillary leak syndrome, tumor cell mobilization, MDS/AML in patients with breast and lung cancer, aortitis, etc.
  1. Dosage/Administration 1

Indication

Dose

Prophylactic use in patients with non-myeloid malignancy

  • Administer 20 mg subcutaneously once per chemotherapy cycle at least 24 hours after cytotoxic chemotherapy. Do not administer within 14 days before and <24 hours after administration of cytotoxic chemotherapy.

Note: Ryzneuta is administered subcutaneously via a single-dose prefilled syringe by a healthcare professional.

  1. Billing Code/Availability Information

HCPCS Code:

  • J3590 – Unclassified biologics

NDC:

  • Ryzneuta 20 mg/mL prefilled syringe: 73491 -0627-xx
  1. References
  1. Ryzneuta [package insert].  Singapore; Evive Biotech., LTD; November 2023. Accessed December 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) efbemalenograstim. 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 December 2023.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hematopoietic Cell Transplantation Version 3.2023. National Comprehensive Cancer Network, 2023. 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 Guidelines, go online to NCCN.org. Accessed December 2023.
  4. Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015 Oct 1;33(28):3199-212. doi: 10.1200/JCO.2015.62.3488.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

D61.81

Pancytopenia

D70.1

Agranulocytosis secondary to cancer chemotherapy

D70.9

Neutropenia, unspecified

T45.1X5A

Adverse effect of antineoplastic and immunosuppressive drugs initial encounter

T45.1X5D

Adverse effect of antineoplastic and immunosuppressive drugs subsequent encounter

T45.1X5S

Adverse effect of antineoplastic and immunosuppressive drugs sequela

Z41.8

Encounter for other procedures for purposes other than remedying health state

Z51.11

Encounter for antineoplastic chemotherapy

Z51.12

Encounter for antineoplastic immunotherapy

Z51.89

Encounter for other specified aftercare

Z76.89

Persons encountering health services in other specified circumstances

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/LCA/LCD): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions5

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