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Rolvedon™ (eflapegrastim-xnst) (Subcutaneous)

Policy Number: VP-676

Last Review Date: 07/05/2023

Date of Origin: 10/03/2022

Dates Reviewed: 10/2022, 04/2023, 07/2023

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 Authorization1

  • Coverage will be provided for 4 months and may be renewed unless otherwise specified.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Rolvedon 13.2 mg prefilled syringe: 1 syringe per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 132 billable units (13.2 mg) per 14 days

III. Initial Approval Criteria 1,2,4-6

Coverage is provided in the following conditions:

For PEEHIP Members Only

  • Fulphila (pegfilgrastim-jmdb) is the preferred product and all other pegfilgrastim/ eflapegrastim 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 pegfilgrastim/eflapegrastim product; OR Patient is continuing treatment with a non-preferred pegfilgrastim/eflapegrastim 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

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 Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

*Febrile neutropenia 2 is defined as:

  • 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.org2

IV. 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.

V. Dosage/Administration 1

Indication

Dose

Prophylactic use in patients with non-myeloid malignancy

The recommended dosage of Rolvedon is a single subcutaneous injection of 13.2 mg administered** once per chemotherapy cycle. Administer approximately 24 hours after cytotoxic chemotherapy.

**Rolvedon may be self-administered or administered by a caregiver or healthcare professional.

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

VI. Billing Code/Availability Information

HCPCS Code:

  • J1449 – Injection, eflapegrastim-xnst, 0.1 mg; 1 billable unit = 0.1 mg

NDC:

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

VII. References

  1. Rolvedon [package insert]. Irvine, CA; Spectrum Pharm., Inc; June 2023. Accessed June 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) eflapegrastim. 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 February 2023.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Hematopoietic Growth Factors. Version 1.2023.  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 February 2023.
  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 LongActing GranulocyteColony Stimulating Factor for the Management of ChemotherapyInduced 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

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)

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

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