Last Review Date:  10/03/2022

Date of Origin: 10/03/2022

Dates Reviewed: 10/2022

1. Length of Authorization¹

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

2. Dosing Limits

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

• Rolvedon 13.2 mg prefilled syringe: 1 syringe per 14 days

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

• 132 billable units (13.2 mg) per 14 days

3. Initial Approval Criteria ^1,2,4-6

Coverage is provided in the following conditions:

Prophylactic use in adult patients with solid tumors or non-myeloid malignancy †

• 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
• Persistent neutropenia (ANC ≤ 1000/mm³)
• Bone marrow involvement by 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-labeled indication(s); ‡ Compendia recommended indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage for all other indications can be renewed based upon 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 rupture, acute respiratory distress syndrome (ARDS), serious allergic reactions/ anaphylaxis, sickle cell crisis, glomerulonephritis, leukocytosis, thrombocytopenia, capillary leak syndrome, potential for tumor growth stimulation of malignant cells, aortitis, myelodysplastic syndrome and acute myeloid leukemia, etc.

5. Dosage/Administration ¹

*Do not administer within 14 days before and 24 hours after administration of cytotoxic chemotherapy.

6. Billing Code/Availability Information

HCPCS Code:

• J3590 – Unclassified biologics (Discontinue use on 04/01/2023)
• J1449 – Injection, eflapegrastim-xnst, 0.1 mg; 1 billable unit = 0.1 mg (Effective 04/01/2023)

NDC:

• Rolvedon 13.2 mg prefilled syringe: 76961-0101-xx

7. References

1. Rolvedon [package insert]. Irvine, CA; Spectrum Pharm., Inc; September 2022.  Accessed September 2022.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) eflapegrastim. 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 September 2022.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Hematopoietic Growth Factors. Version 1.2022.  National Comprehensive Cancer Network, 2021. 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 September 2022.
4. Schwartzberg LS, Bhat G, Bharadwaj JS, et al. Eflapegrastim, a novel and potent long-acting GCSF for reducing chemotherapy-induced neutropenia: Integrated results from two phase III trials in breast cancer patients. DOI: 10.1200/JCO.2019.37.15_suppl.539 Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019) 539-539.
5. Schwartzberg LS, Bhat G, Peguero J, et al. Eflapegrastim, a Long‐Acting Granulocyte‐Colony Stimulating Factor for the Management of Chemotherapy‐Induced Neutropenia: Results of a Phase III Trial, The Oncologist, Volume 25, Issue 8, August 2020, Pages e1233–e1241, https://doi.org/10.1634/theoncologist.2020-0105
6. Cobb PW, Moon YW, Mezei K, et al. A comparison of eflapegrastim to pegfilgrastim in the management of chemotherapy-induced neutropenia in patients with early-stage breast cancer undergoing cytotoxic chemotherapy (RECOVER): A Phase 3 study. Cancer Medicine. Volume9, Issue17. September 2020. Pages 6234-6243. https://doi.org/10.1002/cam4.3227

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: http://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