​

Last Review Date: 01/04/2024

Date of Origin: 01/04/2024

Dates Reviewed: 01/2024

1. Length of Authorization

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

2. Dosing Limits

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

• Ryzneuta 20 mg/mL prefilled syringe: 1 syringe per 14 days

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

• 20 mg per 14 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• 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.

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

4. 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.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J3590 – Unclassified biologics

NDC:

• Ryzneuta 20 mg/mL prefilled syringe: 73491 -0627-xx

7. 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

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

​