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Efbemalenograstim alfa-vuxw (Ryzneuta®), Eflapegrastim-xnst (Rolvedon™), Pegfilgrastim (Neulasta®) and Related Biosimilars
MA08.082l

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.​ 

MEDICALLY NECESSARY

COMPANY-DESIGNATED PREFERRED PRODUCTS 

Although there are many pegfilgrastim​ products on the market (e.g., pegfilgrastim [Neulasta], pegfilgrastim-apgf [Nyvepria], pegfilgrastim-bmez [Ziextenzo], pegfilgrastim-cbqv [Udenyca], ​pegfilgrastim-jmdb [Fulphila], pegfilgrastim-pbbk [Fylnetra], pegfilgrastim-fpgk [Stimufend]) and one eflapegrastim product on the market (e.g., eflapegrastim-xnst [Rolvedon]and one efbemalenograstim product on the market (e.g., efbemalenograstim alfa-vuxw [Ryzneuta])there is no reliable evidence of the superiority of any of these products. The Company has designated the following pegfilgrastim products as its preferred products:
  • Pegfilgrastim (Neulasta) 
  • Pegfilgrastim-apgf (Nyvepria)​
These products are less costly and at least as likely to produce equivalent therapeutic results as the nonpreferred products, which include, but are not limited to, ​pegfilgrastim-cbqv (Udenyca), pegfilgrastim-pbbk (Fylnetra), pegfilgrastim-fpgk (Stimufend), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-jmdb (Fulphila​)eflapegrastim-xnst (Rolvedon)efbemalenograstim alfa-vuxw (Ryzneuta) or any other nonpreferred pegfilgrastim biosimilars, efbemalenograstim or​ eflapegrastim​ ​product.

According to the US Food and Drug Administration (FDA), “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.” Coverage of a biosimilar product as an alternate to a reference product is not considered a form of step therapy by the Company.

NONPREFERRED PRODUCTS 
Use of the nonpreferred pegfilgrastim products or eflapegrastim​ product, which include, but are not limited to, ​pegfilgrastim-cbqv (Udenyca), pegfilgrastim-pbbk (Fylnetra), pegfilgrastim-fpgk (Stimufend), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-jmdb (Fulphila​)eflapegrastim-xnst (Rolvedon), efbemalenograstim alfa-vuxw (Ryzneuta) or any other nonpreferred pegfilgrastim biosimilars, efbemalenograstim or eflapegrastim​ product is considered medically necessary and, therefore, covered only for individuals who are currently receiving or have previously received a nonpreferred product for the specified pegfilgrastim​ indication.​​

If the individual has not previously received pegfilgrastim-cbqv (Udenyca), pegfilgrastim-pbbk (Fylnetra), pegfilgrastim-fpgk (Stimufend), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-jmdb (Fulphila​)​eflapegrastim-xnst (Rolvedon), efbemalenograstim alfa-vuxw (Ryzneuta) or any other nonpreferred pegfilgrastim biosimilars, efbemalenograstim or eflapegrastim​ product​ to treat the specified indication, these nonpreferred products are only ​eligible for coverage when the individual has contraindication(s) or intolerance(s) to the Company-designated preferred products.


EFBEMALENOGRASTIM ALFA-VUXW (RYZNEUTA), EFLAPEGRASTIM-XNST (ROLVEDON), PEGFILGRASTIM (NEULASTA), AND RELATED BIOSIMILARS  
Efbemalenograstim alfa-vuxw (Ryzneuta), Eflapegrastim-xnst (Rolvedon), Pegfilgrastim (Neulasta), and related biosimilars are considered medically necessary and, therefore, covered when used as recommended by the then-current National Comprehensive Cancer Network ​(NCCN) and American Society of Clinical Oncology (ASCO)​ guidelines for any of the following indications:
  • Prophylaxis of myelosuppressive chemotherapy-induced febrile neutropenia or other dose-limiting neutropenic events in high-risk† (>20% ​overall risk of febrile neutropenia) individuals with solid tumors and nonmyeloid malignancies receiving treatment in the curative/adjuvant or palliative settings
  • Prophylaxis of myelosuppressive chemotherapy-induced febrile neutropenia or other dose-limiting neutropenic events in intermediate-risk​(10%20% overall ​risk of febrile neutropenia with one of more risk factors below) or low-risk (<10% overall risk of febrile neutropenia with two or more risk factors belowin​ individuals with solid tumors and nonmyeloid malignancies receiving treatment in the curative/adjuvant or palliative settings who have one or more of the following risk factors: 
    • Prior chemotherapy or radiation therapy
    • Persistent neutropenia
    • Bone marrow involvement by tumor
    • Recent surgery and/or open wounds
    • Liver dysfunction (bilirubin >2 mg/dL)
    • Renal dysfunction (creatinine clearance <50 mL/min)
    • Age greater than 65 years receiving full chemotherapy dose intensity
    • Poor performance status (Eastern Cooperative Oncology Group [ECOG] Performance Status 3-4)
    • Human immunodeficiency virus (HIV) infection with low CD4 counts (450 cells/mm3 or less)
    • Chronic immunosuppression in the posttransplant setting, including organ transplant
*See Attachment A for examples of disease settings and chemotherapy regimens with a high (>20%) or intermediate (10-20%) risk for febrile neutropenia. (Note: These are not all-inclusive lists)
​​
  • Prophylaxis of chemotherapy-induced febrile neutropenia in individuals with one of the following indications, regardless of risk status:
    • Acute lymphoblastic leukemia (ALL) ​or acute myeloid leukemia (AML) in pediatric individuals who have relapsed disease and have serious/life-threatening neutropenic infection
    • Diffuse aggressive lymphoma in individuals age 65 years and older treated with curative chemotherapy regimen cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP) 
    • In pediatric individuals in whom dose-intense chemotherapy is administered for an indication that is known to have a survival benefit (e.g., Ewing sarcoma) 
    • Dose-dense therapy (standard doses given more frequently) for the adjuvant treatment of high-risk breast cancer or for use of high-dose intensity methotrexate, vinblastine, doxorubicin, and cisplatin (HD-MVAC) in urothelial cancer 
  • Prophylaxis of chemotherapy-induced febrile neutropenia in individuals ​with Wilms tumor (nephroblastoma), when administered with Regimen M and Regimen I for courses of either:  
    • Cyclophosphamide and etoposide
    • Cyclophosphamide, doxorubicin, and vincristine​
  • ​Secondary prophylaxis in individuals who have experienced a neutropenic event from a prior cycle of chemotherapy (for which primary prophylaxis was not received), in which a reduced dose or treatment delay may compromise disease-free or overall survival or treatment outcome 
  • Therapeutic use in individuals with cancer who have fever and neutropenia and are at high risk for infection-associated complications or who have prognostic factors that are predictive of poor clinical outcomes. High-risk features include the following factors: 
    • Expected prolonged (>10 days) and profound (​​<​0.1 × 109/L) neutropenia
    • Age greater than 65 years
    • Pneumonia
    • Hypotension and multiorgan dysfunction (sepsis syndrome)
    • Invasive fungal infection
    • Hospitalization at the time of fever development
    • ​Other clinically documented infections
    • Prior episode of febrile neutropenia
  • Hematopoietic ​subsyndrome of acute radiation syndrome (H-ARS)Therapeutic use after accidental or intentional total body radiation of myelosuppressive doses (>2 Gy), if prolonged delays secondary to neutropenia are expected.  
    • Use of the on-body injector for Neulasta (Neulasta Onpro kit) has not been studied and is not recommended for this indication.
  • Mobilization of peripheral blood progenitor cells prior to autologous transplantation in individuals with hematological malignancies, when used alone, after chemotherapy, or in combination with plerixafor​.
  • After autologous ​or allogeneic hematopoietic stem cell transplant to reduce the duration of severe neutropenia.​
NOT MEDICALLY NECESSARY

For individuals receiving their first course of pegfilgrastim or eflapegrastimwhich include, but are not limited to, ​pegfilgrastim-cbqv (Udenyca), pegfilgrastim-pbbk (Fylnetra), pegfilgrastim-fpgk (Stimufend), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-jmdb (Fulphila​), eflapegrastim-xnst (Rolvedon), efbemalenograstim alfa-vuxw (Ryzneuta) or any other nonpreferred pegfilgrastim biosimilars, efbemalenograstim or eflapegrastim product, is considered not medically necessary and, therefore, not covered because they are more costly than the preferred products that are at least as likely to produce equivalent therapeutic results for that individual's condition.

EXPERIMENTAL/INVESTIGATIONAL

All other uses of pegfilgrastim or eflapegrastim​which include but are not limited to, ​​pegfilgrastim-cbqv (Udenyca), pegfilgrastim-pbbk (Fylnetra), pegfilgrastim-fpgk (Stimufend), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-jmdb (Fulphila​),​ eflapegrastim-xnst (Rolvedon)​, efbemalenograstim alfa-vuxw (Ryzneuta) or any other nonpreferred pegfilgrastim biosimilars, efbemalenograstim ​or eflapegrastim product​​​, are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.​

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.

Guidelines

There is no Medicare coverage determination addressing pegfilgrastim (Neulasta); therefore, the Company policy is applicable.

DRUG ADMINISTRATION

Pegfilgrastim (Neulasta) and related biosimilars are available as a single-dose prefilled syringe for manual use only. Pegfilgrastim (Neulasta) is also available as a single-dose prefilled syringe co-packed with the on-body injector (OBI)​ for Neulasta (Neulasta Onpro kit).

Efbemalenograstim alfa-vuxw (Ryzneuta) is available as a single-dose prefilled syringe.

Eflapegrastim-xnst (Rolvedon) is available as a single-dose prefilled syringe for manual use only.

Pegfilgrastim-cbqv (Udenyca) is available as a single-dose prefilled syringe for manual use only and​ as a single-dose prefilled autoinjector. 

Definitions according to National Comprehensive Cancer Network (NCCN) are as follows: 

  • Febrile neutropenia (FN): Febrile Neutropenia is defined as an absolute neutrophil count (ANC) of less than 500 neutrophils/mcL, or an anticipated decline to 500 neutrophils/mcL or less within the next 48 hours, accompanied by a single oral temperature of 38.3°C or more or a temperature of 38°C or more for a duration of over 1 hour.
  • High risk for febrile neutropenia (FN): Chemotherapy regimens for which clinical trial data show an incidence of FN greater than 20% in chemotherapy-naïve patients.
  • Intermediate risk for FN: Chemotherapy regimens for which clinical trial data show an incidence of FN between 10% and 20% in chemotherapy-naïve patients.
  • Low risk for FN: Chemotherapy regimens for which clinical trial data show an incidence of FN is less than 10% in chemotherapy-naïve patients.​
BENEFIT APPLICATION

Subject to the applicable Evidence of Coverage, efbemalenograstim alfa-vuxw (Ryzneuta), eflapegrastim-xnst (Rolvedon), pegfilgrastim (Neulasta) and related biosimilars are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met.

For Medicare Advantage members, certain drugs are available through either the member's medical benefit (Part B benefit) or pharmacy benefit (Part D benefit), depending on how the drug is prescribed, dispensed, or administered. This medical policy only addresses instances when efbemalenograstim alfa-vuxw (Ryzneuta), eflapegrastim-xnst (Rolvedon), pegfilgrastim (Neulasta) and related biosimilars are covered under a member's medical benefit (Part B benefit). It does not address instances when efbemalenograstim alfa-vuxw (Ryzneuta), eflapegrastim-xnst (Rolvedon), pegfilgrastim (Neulasta) and related biosimilars are covered under a member’s pharmacy benefit (Part D benefit).

However, biosimiliars that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Pegfilgrastim (Neulasta) was approved by the FDA on January 31, 2002, to decrease the incidence of infection, as manifested by febrile neutropenia, in individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Supplemental approvals for pegfilgrastim (Neulasta) have since been issued by the FDA. The FDA has also issued subsequent approvals for biosimilar products.

Eflapegrastim-xnst (Rolvedon)​ was approved by the FDA on September 9, 2022 and Efbemalenograstim alfa-vuxw (Ryzneuta) was approved by the FDA on November 22, 2023to decrease the incidence of infection, as manifested by febrile neutropenia, in adult individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.​ Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.​

PEDIATRIC USE

The safety and effectiveness of efbemalenograstim alfa-vuxw (Ryzneuta), ​eflapegrastim-xnst (Rolvedon), pegfilgrastim (Neulasta) and related biosimilars have been established in pediatric patients. Use of the OBI for Neulasta (Neulasta Onpro kit) has not been studied in pediatric patients.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The ECOG, established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern United States to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

ECOG Performance Status
Grade
ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work)
2
Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3
Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4
Completely disabled. Cannot carry on any self-care: totally confined to bed or chair
5
Dead

Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

Description

Certain intensive cytotoxic chemotherapy regimens are known to cause severe, prolonged febrile neutropenia that may increase the risk of infections and hospitalization. The risk of febrile neutropenia is related to the treatment regimen and delivered dose intensity. The National Comprehensive Cancer Network (NCCN) defines febrile neutropenia as a single temperature of 38.3°C or greater orally, or 38.0°C over 1 hour; neutropenia as less than 500 neutrophils/mcL or less than 1000 neutrophils/mcL and a predicted decline to 500 neutrophils/mcL or less over the next 48 hours.

Granulocyte colony-stimulating factor (G-CSF) has been shown to reduce the duration and severity of neutropenia, as well as the risk of febrile neutropenia, thereby enabling the delivery of the current dose of chemotherapy or even dose-intensive (increased dose) or dose-dense (increased frequency) regimens when indicated. Without the use of G-CSFs in some chemotherapy regimens, the need to reduce the chemotherapeutic dose may cause a poor prognosis for the individual.

Pegfilgrastim (Neulasta) is a G-CSF that affects the proliferation and differentiation of neutrophils within the bone marrow. Pegfilgrastim (Neulasta) was approved by the US Food and Drug Administration (FDA) in 2002 to decrease the incidence of infection, as manifested by febrile neutropenia, in individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. A subsequent indication was FDA-approved to increase survival in individuals acutely exposed to myelosuppressive doses of radiation.

Since 2018, the FDA has approved several biosimilar products. These are highly similar to the reference biologic, pegfilgrastim (Neulasta), and have the same indications; there are no clinically meaningful differences between the biosimilars and the reference product.

Efbemalenograstim alfa-vuxw (Ryzneuta) and Eflapegrastim-xnst (Rolvedon)​ are recombinant human granulocyte growth factors that binds to G-CSF receptors on myeloid progenitor cells and neutrophils, triggering signaling pathways that control cell differentiation, proliferation, migration, and survival​. Rolvedon and Ryzneuta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

Aapro MS, Bohlius JCameron DA, et al.; European Organisation for Research and Treatment of Cancer. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011;47(1):8-32.


American Hospital Formulary Service (AHFS). Drug Info 2024. Pegfilgrastim (Neulasta®). [Lexicomp Online Web site]. 01/01/2009. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 16, 2024.


Evidence of coverage.

 ​​

Elsevier's Clinical Pharmacology Compendium. Pegfilgrastim. 02/09/2024. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed February 16, 2024​.


Lexi-Drugs Compendium. Pegfilgrastim. 02/14/2024. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home  [via subscription only]. Accessed February 16, 2024.


Lexi-Drugs Compendium. Eflapegrastim​. 12/18/2023. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home  [via subscription only]. Accessed February 16, 2024.

Lexi-Drugs Compendium. Efbemalenograstim alfa-vuxw​. 11/20/2023. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home  [via subscription only]. Accessed February 16, 2024​.


National Comprehensive Cancer Network (NCCN).  NCCN Clinical Practice Guidelines in Oncology – Hematopoietic cell transplantation. V3.2023. 10/09/2023. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf [via free subscription]. Accessed February 15, 2024


National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Hematopoietic growth factors. V3.2024. 01/30/2024. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf [via free subscription]. Accessed February 15, 2024

 

National Comprehensive Cancer Network (NCCN).  NCCN Clinical Practice Guidelines in Oncology – Wilms Tumor (Nephroblastoma). V1.2023. 03/14/2023. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/wilms_tumor.pdf [via free subscription]. Accessed February 15, 2024.


National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Neulasta (pegfilgrastim), Fulphila (pegfilgrastim-jmdb), Nyvepria (pegfilgrastim-apgf), Udenyca (pegfilgrastim-cbqv), Ziextenzo (pegfilgrastim-bmez), Fylnetra (pegfilgrastim-pbbk), Stimufend (pegfilgrastim-fpgk), Nyvepria (pegfilgrastim-apgf), Rolvedon (eflapegrastim-xnst), Ryzneuta (efbemalenopegrastim alfa-vuxw). [NCCN Web site]. 2024. Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed February 15, 2024​.


Smith TJ, Bohlke K, Lyman GH, et al.; American Society of Clinical Oncology. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33(28):3199-3212.


Smith TJ, Khatcheressian J, Lyman GH, et al.  2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol. 2006;24(19):3187-3205.


Truven Health Analytics IBM- Watson Health. Micromedex® DrugDex® Compendium. Pegfilgrastim. 12/08/2023. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at:​
http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed February 16, 2024​​.

 

Truven Health Analytics IBM- Watson Health. Micromedex® DrugDex® Compendium. Efbemalenograstim alfa-vuxw. 12/18/2023. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at:​

http://www.micromedexsolutions.com/micromedex2/librarian​ [via subscription only]. Accessed February 16, 2024​​.​

 

Truven Health Analytics IBM- Watson Health. Micromedex® DrugDex® Compendium. Eflapegrastim-xnst. 12/08/2023. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at:​

http://www.micromedexsolutions.com/micromedex2/librarian​ [via subscription only]. Accessed February 16, 2024​.​

 
US Food and Drug Administration (FDA). Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. April 2015. ​[FDA Web site]. Available at: https://www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed February 15, 2024.


US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Pegfilgrastim (Neulasta) drug label & approval letter [FDA Web site]. Updated 02/02/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 15, 2024​. 

US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. Pegfilgrastim-apgf (Nyvepria) drug label [FDA Web site]. Updated 04/16/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 15, 2024


US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. pegfilgrastim-bmez (Ziextenzo) drug label [FDA Web site]. Updated 09/2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761045Orig1s011lbl.pdf. Accessed February 15, 2024.


US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. pegfilgrastim-jmdb (Fulphila) drug label [FDA Web site]. Updated 03/17/2021. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 15, 2024​. 

US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. pegfilgrastim-cbqv (Udenyca) drug label [FDA Web site]. Updated 12/2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761039Orig1s015lbl.pdf. Accessed February 15, 2024.


US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. pegfilgrastim-pbbk (Fylnetra) drug label [FDA Web site]. Updated 05/26/2022. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 15, 2024​. 


US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. eflapegrastim-xnst (Rolvedon™ ) drug label [FDA Web site]. Updated 06/2023. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 15, 2024.


US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. Efbemalenopegrastim alfa-vuxw (Ryzneuta) drug label [FDA Web site]. 11/2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761134s000lbl.pdf. Accessed February 15, 2024.


US Food and Drug Administration (FDA). Drugs@FDA: FDA Approved Drug Products. pegfilgrastim-fpgk​ (Stimufend® ) drug label [FDA Web site]. Updated 09/2023. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761173s002lbl.pdf. Accessed February 15, 2024.  

​Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol. 2005;23(6):1178-1184.


Coding

CPT Procedure Code Number(s)
N/A

ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)

C64.1 Malignant neoplasm of right kidney, except renal pelvis
C64.2 Malignant neoplasm of left kidney, except renal pelvis
C91.00 Acute lymphoblastic leukemia not having achieved remission
C91.02 Acute lymphoblastic leukemia, in relapse
C92.00 Acute myeloblastic leukemia, not having achieved remission
C92.02 Acute myeloblastic leukemia, in relapse
C92.50 Acute myelomonocytic leukemia, not having achieved remission
C92.52 Acute myelomonocytic leukemia, in relapse
C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
C93.02 Acute monoblastic/monocytic leukemia, in relapse
C93.30 Juvenile myelomonocytic leukemia, not having achieved remission
C93.32 Juvenile myelomonocytic leukemia, in relapse
D61.810 Antineoplastic chemotherapy induced pancytopenia
D61.811 Other drug-induced pancytopenia
D61.818 Other pancytopenia
D70.1 Agranulocytosis secondary to cancer chemotherapy
D70.2 Other drug-induced agranulocytosis
D70.3 Neutropenia due to infection
D70.8 Other neutropenia
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
T66.XXXA Radiation sickness, unspecified, initial encounter
T66.XXXD Radiation sickness, unspecified, subsequent enounter
T66.XXXS Radiation sickness, unspecified, sequela
Z51.11  Encounter for antineoplastic chemotherapy
Z51.12  Encounter for antineoplastic immunotherapy
Z94.84 Stem cell transplant status​


HCPCS Level II Code Number(s)

​J1449 Injection, eflapegrastim-xnst, 0.1 mg
J2506 Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Q5108 Injection, pegfilgrastim-jmdb (fulphila), biosimilar, 0.5 mg
Q5111 Injection, pegfilgrastim-cbqv (udenyca), biosimilar, 0.5 mg
Q5120 Injection, pegfilgrastim-bmez (ziextenzo), biosimilar, 0.5 mg
Q5122 Injection, pegfilgrastim-apgf (nyvepria), biosimilar, 0.5 mg
Q5127 Injection, pegfilgrastim-fpgk (stimufend), biosimilar, 0.5 mg
Q5130 Injection, pegfilgrastim-pbbk (fylnetra), biosimilar, 0.5 mg


THE FOLLOWING CODE(S) ARE USED TO REPRESENT EFBEMALENOGRASTIM ALFA-VUXW (RYZNEUTA):
C9399   Unclassified drugs or biologicals
J3590    Unclassified biologics ​


Revenue Code Number(s)
N/A




Coding and Billing Requirements


Policy History

4/8/2024
4/8/2024
MA08.082
Medical Policy Bulletin
Medicare Advantage
{"943": {"Id":943,"MPAttachmentLetter":"A","Title":"EXAMPLES OF DISEASE SETTINGS AND CHEMOTHERAPY REGIMENS WITH A HIGH (>20%) OR INTERMEDIATE (10-20%) RISK FOR FEBRILE NEUTROPENIA","MPPolicyAttachmentInternalSourceId":8496,"PolicyAttachmentPageName":"e3af7bcc-127a-4c6f-9879-44060ddba4d3"},}
No