Subject:
Granulocyte Colony Stimulating Factor (G-CSF - Neupogen, Neulasta, Granix, Zarxio, Fulphila, Nivestym, Udenyca, Ziextenzo, Nyvepria) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF - Leukine)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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The colony stimulating factors such as granulocyte colony stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF) stimulate the production of neutrophils in the bone marrow. Together, G-CSF and GM-CSF exert major control over the reproduction and maturation of committed myeloid-lineage progenitor cells. G-CSF is utilized later in the course of development of specific cell lines and preferentially stimulates the proliferation, differentiation, and functional activity of the neutrophil granulocyte lineage. G-CSF primes neutrophils for enhanced oxidative metabolism, increases antibody dependent cell mediated cytotoxicity (ADCC) by neutrophils and enhances phagocytosis, among other effects. GM-CSF acts predominantly on pluripotent stem cells and immature progenitor cells. Unlike G-CSF, it is not lineage specific, is required throughout differentiation, proliferation, and self-renewal of stem cells, and affects neutrophil granulocyte, eosinophil, thrombocyte, monocyte, and macrophage precursors. Functional effects of GM-CSF include increased phagocytosis, enhanced superoxide production by neutrophils, and increased ADCC.
Filgrastim and Pegfilgrastim are human granulocyte colony-stimulating factor (G-CSF), produced by recombinant DNA technology. Pegfilgrastim is a covalent conjugate of recombinant filgrastim and monomethoxypolyethylene glycol. Filgrastim and Pegfilgrastim have the same mechanism of action by stimulating hematopoietic cells. However, pegfilgrastim has reduced renal clearance and prolonged persistence in vivo compared to filgrastim. Filgrastim is marketed as Neupogen and Pegfilgrastim as Neulasta by Amgen, Inc.
Tbo-filgrastim is a human granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. Tbo-filgrastim binds to G-CSF receptors and stimulates proliferation of neutrophils. G-CSF is known to stimulate differentiation commitment and some end-cell functional activation, which increases neutrophil counts and activity.Tbo-filgrastim is marketed as Granix™.
Sargramostim is a human granulocyte-macrophage colony-stimulating factor (GM-CSF) also produced by recombinant DNA technology. Sargramostim is marketed as Leukine by Bayer Corp.
On March 6, 2015, the FDA approved the first biosimilar product by Sandoz, Inc. called Zarxio (filgrastim-sndz) under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).It is a biosimilar to Amgen, Inc’s Neupogen, a G-CSF. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the references product. It should be noted that Zarxio and Neupogen are not interchangeable.
On June 4, 2018, the FDA approved a biosimilar product by Mylan GmbH called Fulphila (pegfilgrastim-jmdb). It is the first biosimilar to Amgen, Inc.’s Neulasta, a G-CSF. A biosimilar product is a biological product that is approved based on a showing that is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the references product.
On July 20, 2018 the FDA approved a biosimilar product by Hospira, Inc., a Pfizer company called Nivestym (filgrastim-aafi). It is the second biosimilar to Amgen, Inc’s Neupogen, a G-CSF. A biosimilar product is a biological product that is approved based on a showing that is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the references product. Nivestym has five approved indications shared with Neupogen.
On November 2, 2018, the FDA approved a biosimilar product by Coherus BioSciences, Inc. called Udenyca (pegfilgrastim-cbqv). It is the second biosimilar to Amgen, Inc.'s Neulasta, a G-CSF. A biosimilar product is a biological product that is approved based on a showing that is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the references product.
On November 5, 2019, the FDA approved a biosimilar product by Sandoz Inc called Ziextenzo (pegfilgrastim- bmez). It is the third biosimilar to Amgen, Inc.’s Neulasta, a G-CSF. A biosimilar product is a biological product that is approved based on a showing that is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the references product.
On June 10, 2020 the FDA approved a biosimilar product by Pfizer called Nyvepria (pegfilgrastim-apgf). It is the fourth biosimilar to Amgen, Inc.’s Neulasta, a G-CSF. A biosimilar product is a biological product that is approved based on a showing that is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the references product. Like the other biosimilar pegfilgrastim products, it has been approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Also like the other biosimilar pegfilgrastim products, Nyvepria is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
The requirements of the Horizon BCBSNJ Granulocyte Colony Stimulating Factor (G-CSF - Neupogen, Neulasta, Granix, Zarxio, Fulphila, Nivestym, Udenyca, Ziextenzo, Nyvepria) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF - Leukine) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
[INFORMATIONAL NOTE: Eligibility of colony stimulating factors when administered in conjunction with bone marrow transplantation is subject to contractual limitation and exclusion of the member's contract benefits for bone marrow transplantation, and medical necessity of the transplantation procedure. Please refer to separate medical policies in the Treatment Section on Bone Marrow and Peripheral Blood Stem Cell Transplantation for criteria on medical necessity.]
I. Colony stimulating factors are medically necessary for the following indications when the prescriber is a specialist in the area of the patient's diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient's diagnosis:
[INFORMATIONAL NOTE:
- The degree of neutropenia is expressed by the absolute neutrophil count (ANC). The ANC is defined as the total number of granulocytes (polymorphonuclear leukocytes and band forms) present in the circulating pool of white blood cells (WBCs). ANC= WBC x (% of neutrophils + % of Bands). In general, the risk of infection is low when the ANC exceeds 1000/mm3; however, as the ANC drops below 500/mm3, the risk of infection rapidly increases.
According to the World Health Organization (WHO);
- Neutropenia = ANC < 2000/mm3 (slight risk of infection);
- Mild Neutropenia = ANC > 1000/mm3 & < 1500/mm3 (minimal risk of infection);
- Moderate Neutropenia = ANC > 500/mm3 & < 1000/mm3 (moderate risk of infection);
- Severe Neutropenia = ANC < 500/mm3 (severe risk of infection).
- Clinical signs of febrile neutropenia include fever > 38.3oC (100.9 oF) or ≥ 38.0oC (100.4 oF) over 1 hour orally and ANC < 500/mm3 or <1000/mm3 and a predicted decline to ≤500/mm3 over the next 48 hrs.
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- The National Comprehensive Cancer Network (NCCN) defines high risk as a 20% or higher probability of developing febrile neutropenia (FN).
- The following are examples of chemotherapy regimens with a high risk of febrile neutropenia (>20%):
- MVAC (MTX, vinblastine, doxorubicin, cisplatin)
- Docetaxel + trastuzumab
- Dose dense AC T (doxorubicin, cyclophosphamide, paclitaxel)
- AT (doxorubicin, paclitaxel or docetaxel)
- TAC (docetaxel, doxorubicin, cyclophosphamide)
- Docetaxel/cisplatin/fluorouracil
- ICE (ifosfamide, carboplatin, etoposide)
- RICE (rituximab, ifosfamide, carboplatin, etoposide)
- CHOP-14 (cyclophosphamide, doxorubicin, vincristine, prednisone)
- MINE (mesna, ifosfamide, novantrone and etoposide)
- DHAP (dexamethasone, cisplatin, cytarabine)
- ESHAP (etoposide, methylprednisolone, cisplatin, cytarabine)
- BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone)
- HyperCVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone) + Rituximab
- Dacarbazine-based combination (dacarbazine, cisplatin, vinblastine)
- Dacarbazine-based combination with IL-2, interferon alfa (dacarbazine, cisplatin, vinblastine, IL-2, interferon alfa)
- Decitabine
- Topotecan
- Paclitaxel
- Docetaxel
- Gemcitabine/docetaxel
- MAID (mesna, doxorubicin, ifosfamide, dacarbazine)
- Doxorubicin
- VelP (vinblastine, ifosfamide, cisplatin)
- VIP (etoposide, ifosfamide, cisplatin)
- BEP (bleomycin, etoposide, cisplatin)
- TIP (paclitaxel, ifosfamide, cisplatin)
- The following are examples of chemotherapy regimens with an intermediate risk of febrile neutropenia (10-20%):
- Gemcitabine, docetaxel
- Docetaxel
- Epirubicin
- Epirubicin + sequential cyclophosphamide + methotrexate + 5-fluorouracil
- CMF classic (cyclophosphamide, methotrexate, fluorouracil)
- AC (doxorubicin, cyclophosphamide) + sequential docetaxel (taxane portion only)
- AC + sequential docetaxel + trastuzumab
- FEC (fluorouracil, epirubicin, cyclophosphamide) + sequential docetaxel
- Paclitaxel every 21 days
- Vinblastine
- Cisplatin + topotecan
- Topotecan
- Irinotecan
- FOLFOX (fluorouracil, leucovorin, oxaliplatin)
- Irinotecan/cisplatin
- Epirubicin/cisplatin/5-fluorouracil
- Epirubicin/cisplatin/capecitabine
- ABVD (doxorubicin, bleomycin, vinblastine, decarbazine)
- Stanford V (mechlorethamine, doxorubicin, vinblastine, bleomycin, etoposide, prednisone)
- EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin)
- EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) + IT chemotherapy
- Rituximab + HyperCVAD alternating with methotrexate + cytarabine (CVAD template)(cyclophosphamide, vincristine, doxorubicin, dexamethasone) regimen included IT methotrexate
- ACOD (modified CHOP-doxorubicin, cyclophosphamide, vincristine, prednisone)
- GDP (gemcitabine, dexamethasone, cisplatin)
- GDP (gemcitabine, dexamethasone, cisplatin) + rituximab
- FM (fludarabine, mitoxantrone)
- CHOP + R (cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab)
- Cisplatin/paclitaxel
- Cisplatin/vinorelbine
- Cisplatin/docetaxel
- Cisplatin/etoposide
- Carboplatin/paclitaxel
- Carboplatin/docetaxel
- Etoposide/carboplatin]
1. Filgrastim (Neupogen)
A. Primary prophylaxis in adult and pediatric members with non-myeloid malignancies receiving established myelosuppressive chemotherapy that is expected to result in at least a 20% incidence of severe febrile neutropenia AND member must try and have an inadequate response or adverse event to Granix OR Zarxio
B. Prophylaxis in members receiving myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10%-20% who are at increased risk for chemotherapy-induced infectious complications because of bone marrow compromise or comorbidity, including such factors as:
1. Prior chemotherapy or radiation therapy
2. Persistent Neutropenia
3. Bone marrow involvement by tumor
4. Recent surgery and/or open wounds
5. Liver dysfunction (bilirubin > 2.0)
6. Renal dysfunction (creatine clearance <50)
7. Age >65 years receiving full chemotherapy dose intensity
8. Poor performance status
9. HIV Infection
10. Chronic immunosuppression in the post-transplant setting, including organ transplant
AND
- Member must try and have an inadequate response or adverse event to Granix OR Zarxio
C. Decreasing the duration of neutropenia and fever after the completion of AML induction or consolidation chemotherapy in adult members AND member must try and have an inadequate response or adverse event to Zarxio
[INFORMATIONAL NOTE: Caution is recommended in patients with myeloid malignancies such as AML because of the potential of colony stimulating factors to stimulate leukemic blasts. Filgrastim (Neupogen) is not recommended for administration before or with chemotherapy in patients with AML.]
D. Chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic members with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia AND ANC < 500/mm3 AND member must try and have an inadequate response or adverse event to Zarxio
[INFORMATIONAL NOTE: Severe neutropenia is considered to exist when the ANC < 500/mm3. Serial CBC’s with differential and platelet counts and an evaluation of bone marrow morphology and karyotype should be performed prior to initiation of therapy.]
E. Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (AIDS) members with neutropenia caused by the disease itself or infection with opportunistic organisms (such as cytomegalovirus), or antiretroviral agents (zidovudine, ganciclovir).
F. Prolonging survival in members who have undergone allogeneic or autologous BMT in whom engraftment is delayed or has failed, in the presence or absence of infection.
G. After completion of the first few days of chemotherapy of the initial induction or first postremission course in members with acute lymphoblastic leukemia.
H. Mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis for members who are undergoing peripheral blood progenitor cell collection and therapy AND member must try and have an inadequate response or adverse event to Zarxio
I. Drug-induced neutropenia.
[INFORMATIONAL NOTE: Drugs that may cause neutropenia include methotrexate, clozapine, methimazole, captopril, procainamide, gold, phenothiazide, azathioprine, ticlopidine, phenobarbital, phenytoin, ciprofloxacin, penfloxacin, cefuroxime, chloramphenicol, sulfasalazine.]
J. Acceleration of myeloid recovery in members with nonmyeloid malginancies undergoing autologous or allogeneic bone marrow transplantation (BMT) following myeloablative chemotherapy AND member must try and have an inadequate response or adverse event to Zarxio
[INFORMATIONAL NOTE: When filgrastim (Neupogen) is used in patients receiving myelosuppressive antineoplastic therapy, a complete blood cell count (CBC) and platelet count should be performed prior to chemotherapy to determine baseline values. CBCs and platelet counts should be performed twice weekly during filgrastim therapy to monitor the neutrophil count and avoid excessive leukocytosis.]
10. Chronic immunosuppression in the post-transplant setting, including organ transplant
AND
7. Pegfilgrastim-jmdb (Fulphila)
A. Primary prophylaxis in previously untreated adult and pediatric members with non-myeloid malignancies receiving established myelosuppressive chemotherapy that is expected to result in at least a 20% greater incidence of severe febrile neutropenia
B. Prophylaxis in members receiving myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10%-20% who are at increased risk for chemotherapy-induced infectious complications because of bone marrow compromise or comorbidity, including such factors as:
1. Prior chemotherapy or radiation therapy
2. Persistent Neutropenia
3. Bone marrow involvement by tumor
4. Recent surgery and/or open wounds
5. Liver dysfunction (bilirubin > 2.0)
6. Renal dysfunction (creatine clearance <50)
7. Age >65 years receiving full chemotherapy dose intensity
8. Poor performance status
9. HIV Infection
10. Chronic immunosuppression in the post-transplant setting, including organ transplant
8. Pegfilgrastim-cbqv (Udenyca)
A. Primary prophylaxis in previously untreated adult and pediatric members with non-myeloid malignancies receiving established myelosuppressive chemotherapy that is expected to result in at least a 20% greater incidence of severe febrile neutropenia
B. Prophylaxis in members receiving myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10%-20% who are at increased risk for chemotherapy-induced infectious complications because of bone marrow compromise or comorbidity, including such factors as:
1. Prior chemotherapy or radiation therapy
2. Persistent Neutropenia
3. Bone marrow involvement by tumor
4. Recent surgery and/or open wounds
5. Liver dysfunction (bilirubin > 2.0)
6. Renal dysfunction (creatine clearance <50)
7. Age >65 years receiving full chemotherapy dose intensity
8. Poor performance status
9. HIV Infection
10. Chronic immunosuppression in the post-transplant setting, including organ transplant
9. Pegfilgrastim-bmez (Ziextenzo)
A. Primary prophylaxis in previously untreated adult and pediatric members with non-myeloid malignancies receiving established myelosuppressive chemotherapy that is expected to result in at least a 20% greater incidence of severe febrile neutropenia AND member must try and have an inadequate response or adverse event to Neulasta, Fulphila and Udencya
B. Prophylaxis in members receiving myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10%-20% who are at increased risk for chemotherapy-induced infectious complications because of bone marrow compromise or comorbidity, including such factors as:
1. Prior chemotherapy or radiation therapy
2. Persistent Neutropenia
3. Bone marrow involvement by tumor
4. Recent surgery and/or open wounds
5. Liver dysfunction (bilirubin > 2.0)
6. Renal dysfunction (creatine clearance <50)
7. Age >65 years receiving full chemotherapy dose intensity
8. Poor performance status
9. HIV Infection
10. Chronic immunosuppression in the post-transplant setting, including organ transplant
AND
Member must try and have an inadequate response or adverse event to Neulasta, Fulphila and Udencya
10. Pegfilgrastim-apgf (Nyvepria)
A. Primary prophylaxis in previously untreated adult and pediatric members with non-myeloid malignancies receiving established myelosuppressive chemotherapy that is expected to result in at least a 20% greater incidence of severe febrile neutropenia AND member must try and have an inadequate response or adverse event to Neulasta, Fulphila and Udencya
B. Prophylaxis in members receiving myelosuppressive chemotherapy with an expected incidence of febrile neutropenia of 10%-20% who are at increased risk for chemotherapy-induced infectious complications because of bone marrow compromise or comorbidity, including such factors as:
1. Prior chemotherapy or radiation therapy
2. Persistent Neutropenia
3. Bone marrow involvement by tumor
4. Recent surgery and/or open wounds
5. Liver dysfunction (bilirubin > 2.0)
6. Renal dysfunction (creatine clearance <50)
7. Age >65 years receiving full chemotherapy dose intensity
8. Poor performance status
9. HIV Infection
10. Chronic immunosuppression in the post-transplant setting, including organ transplant
AND
Member must try and have an inadequate response or adverse event to Neulasta, Fulphila and Udencya
II. When colony stimulating factor is medically necessary for indications as mentioned above, it is covered initially for 8 weeks when not being used in combination with another granulocyte colony-stimulating factor. Continued colony stimulating factor is subject to medical necessity review every 8 weeks thereafter based on the same policy criteria as for initial review and the drug is not being used in combination with another granulocyte colony-stimulating factor.
IV. Other uses of colony stimulating factors are considered investigational. These include, but are not limited to, the following:
A. Routine use in most chemotherapy regimens as prophylaxis.
B. Treatment of aplastic anemia.
C. As a single-agent or in combination therapy for the treatment of melanoma
[INFORMATIONAL NOTE: Preliminary data from a number of small, uncontrolled studies suggest that GM-CSF may have a beneficial role in the adjuvant treatment of this disease. However, further investigation is needed to evaluate the safety and efficacy of GM-CSF in patients with melanoma.]
D. Treatment of myocardial infarction. [Please refer to a separate policy on Autologous Cell Therapy for the Treatment of Damaged Myocardium (Policy #029) under the Medicine Section of this database.]
E. Treatment of ischemic stroke.
F. Treatment of localized prostate cancer prior to surgery.
G. Prophylaxis of infectious disease or as an adjunct to antibiotic therapy.
H. Treatment of pulmonary alveolar proteinosis.
I. Treatment of sepsis of the newborn.
J. Use in preventing or reducing the duration of drug-induced agranulocytosis
K. Treatment of chemotherapy-associated mucositis.
L. In combination with chemotherapy and radiation.
M. Use of GCSF to stimulate the formation of new blood vessels in patients with peripheral artery disease.
N. To reduce risk of Graft vs. Host Disease following allogenic transplantation.
O. Use in Non-Hodgkin’s Lymphoma or myeloma or chronic myeloid leukemia (CML) or breast cancer
P. Mobilization of CD34+ hematopoietic progenitor cells in patients with beta-thalassemia major.
Q. Immunomodulatory therapy for Type 1 Diabetes to preserve insulin production.
R. Recurrent Implantation failure due to endometriosis
S. Treatment Children and Adolescents With Muscular Dystrophy
T. Treatment of Hepatic Failure
U. Amyotrophic Lateral Sclerosis
Medicare Coverage
There is no National Coverage Determination (NCD or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon Policy.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Granulocyte Colony Stimulating Factor (G-CSF) and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Colony Stimulating Factors (G-CSF & GM-CSF)
Filgrastim
G-CSF
GM-CSF
Granulocyte Colony Stimulating Factor
Granulocyte-Macrophage Stimulating Factor
Leukine
Neulasta
Neupogen
Pegfilgrastim
Sargramostim
Zarxio
Pegfilgrastim-jmdb
Fulphila
Pegfilgrastim-bmez
Ziextenzo
Pegfilgrastim-apgf
Nyvepria
References:
1. 2004 Physicians' Desk Reference. 58th Edition. Medical Economics Publishing Company.
2. 2013 AHFS Drug Information. American Society of Health-System Pharmacists, Inc.
3. USPDI 2004: Drug Information for the Health Care Professional. 24th Edition. Micromedex Thomson Healthcare.
4. Neupogen® Prescribing Information. Amgen Inc. Thousand Oaks, CA June 2018. http://www.neupogen.com/pdf/Neupogen_PI.pdf
5. Leukine® Prescribing Information. Partner Therapeutics, Inc. Lexington, MA. May 2018. http://www.leukine.com/pi
6. Neulasta® Prescribing Information. Amgen Inc. Thousand Oaks, CA. January 2020. http//www.neulasta.com
7. Ozer H, Armitage JO, Bennett CL, et al. For the American Society of Clinical Oncology Growth Factors Experts Panel. 2000 update of Recommendations for the Use of Hematopoietic colony-stimulating factor: evidence-based, clinical practice guidelines. J Clin Oncol 2000 Oct 15;18(20):3558-3585.
8. Dieckgraefe BK, Korzenik JR. Treatment of active Crohn’s disease with recombinant human granulocyte-macrophage colony-stimulating factor. Lancet 2002;360:1478-1480.
9. Korzenik J, Dieckgraefe B, Valentine JF, et al. Sargramostim (Leukine), induces response and remission in moderately to severely active Crohn’s disease: results from the first randomized, double-blind, placebo-controlled trial. In: Quigley EMM, ed. Proceedings of the sixty-eighth annual scientific meeting and postgraduate course of the American College of Gastroenterology. Baltimore: 2003: 311. Abstract 49A.
10. Korzenik J, Dieckgraefe B. Immunostimulation in Crohn’s Disease: Retreatment and maintenance therapy with GM-CSF. Gastroenterol 2002:A-432-33. T1204.
11. Angel JB, High K, Rhame F, et al. Phase III study of granulocyte-macrophage colony-stimulating factor in advanced HIV disease: effect on infections, CD4 cell counts, and HIV suppression. AIDS 2000;14(4):387-394.
12. Skowron G, Stein D, Drusano G, et al. The safety and efficacy of granulocyte-macrophage colony stimulating factor (sargramostim) added to Indinavir- or Ritonavir- based antiretroviral therapy: a randomized, double-blind, placebo-controlled trial. Journal of Infectious Disease 1999;180:1064-1071.
13. Davidson M, Min YI, Holbrook JT, et al. Use of filgrastim as adjuvant therapy in patients with AIDS-related cytomegalovirus retinitis. AIDS 2002;16(5):757-765.
14. Spitler L, Grossbard M, et al. Adjuvant Therapy of Stage 111 and 1V malignant melanoma using granulocyte macrophage colony-stimulating factor. J Clinical Oncology 2000;8(8):1614-1621.
15. Myeloid Growth Factors in Cancer Treatment. National Comprehensive Cancer Network: Clinical Practice Guidelines in Oncology. Updated 2005. Available at: http://www.nccn.org/professionals/physician_gls/PDF/myeloid_growth.pdf
16. Woei-Cherng S, Shinn-Zong L, Chau-Chin L, et al. Granulocyte colony-stimulating factor for acute ischemic stroke: a randomized controlled trial. CMAJ 2006;174(7):927-933.
17. Zohlnhofer D, Ott I, Mehilli J, et al. Stem cell mobilization by granulocyte colony-stimulating factor in patients with acute myocardial infarction: a randomized controlled trial. JAMA 2006;295:1003-1010.
18. Korzenik JR, Dieckgraefe BK, Valentine JF, et al. Sargramostim for active Crohn's disease. N Engl J Med 2005;352(21):2193-2201.
19. Korzenik JR, Dieckgraefe BK. An open-labelled study of granulocyte colony-stimulating factor in the treatment of active Crohn's disease. Alimentary Pharmacology & Therapeutics 2005;391(21):1365-2036.
20. Smith TJ, Khatcheran 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):1-19.
21. Myelodysplastic Syndromes. National Comprehensive Cancer Network: Clinical Practice Guidelines in Oncology V.1.2009. Available at: http://www.nccn.org/professionals/physician_gls/PDF/mds.pdf (Accessed 2/27/09)
22. Acute Myeloid Leukemia. National Comprehensive Cancer Network: Clinical Practice Guidelines in Oncology V.1.2009. Available at: http://www.nccn.org/professionals/physician_gls/PDF/aml.pdf (Accessed 2/27/09)
23. Abdel-Latif A, Bolli R, Zuba-Surma EK, et al. Granulocyte colony-stimulating factor therapy for cardiac repair after acute myocardial infarction: A systematic review and meta-analysis of randomized controlled trials. American Heart Journal 2008;156(2):216-226.e9.
24. Carr R, Brocklehurst P, Dore CJ, Modi N. Granulocyte-macrophage colony stimulating factor administered as prophylaxis for reduction of sepsis in extremely preterm, small for gestational age neonates (the PROGRAMS trial): a single-blind, multicentre, randomized controlled trial. Lancet 2009;373:226-33.
25. Dejaco C, Lichtenberger C, Miehsler W, et al. An open-label pilot study of granulocyte colony-stimulating factor for the treatment of severe endoscopic postoperative recurrence in Crohn’s disease. Digestion 2003;68(2-3):63-70.
26. Vial T, Gallant C, Choqu-Kastylevsky G, Descotes J. Treatment of drug-induced agranulocytosis with haematopoietic growth factors: a review of the clinical experience. Biodrugs 1999;11(3):185-200.
27. Nand S, Bayer R, Prinz RA, et al. Granulocyte-macrophage colony stimulating factor for the treatment of drug-induced agranulocytosis. American Journal of Hematology 1991;37(4):267-9 (abstract).
28. Delannoy A. GM-CSF therapy for drug-induced agranulocytosis. Journal of Internal Medicine 1992;231(3):269-71.
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38. Granix™ (tbo-filgrastim). [Packet Insert]. Cephalon, Inc, a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd.. North Wales, PA. November 2019.
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42. FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment. FDA News Release. U.S. Food & Drug Administration. Available online at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609805.htm
43. Udencya (pegfilgrastim-cbqv). [Package Insert.] Coherus BioSciences, Inc. Redwood City, CA. Nov 2018.
44. US FDA approves Udencya (pegfilgrastim-cbqv) [new release]. Coherus BioSciences, Inc. November 2, 2018. https://www.centerforbiosimilars.com/news/fda-approves-coherus-pegfilgrastim-biosimilar-udenyca. Accessed November 5, 2018.
45. NivestymTM (filgrastim-aafi). [Package Insert]. Hospira, Inc. a Pfizer Company. Lake Forest, IL. July 2018.
46. US FDA approves Pfizer’s biosimilar NIVESTYMTM (filgrastim-aafi) [news release]. New York, NY: Pfizer Inc.; July 20, 2018. https://www.pfizer.com/press-release/us-fda-approves-pfizers-biosimilar-nivestym-filgrastim-aafi. Accessed July 23, 2018.
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48. US FDA approves Sandoz’s biosimilar Ziextenzo (pegfilgrastim-bmez) [news release]. November 5, 2019. https://www.centerforbiosimilars.com/news/fda-approves-sandozs-pegfilgrastim-biosimilar-ziextenzo. Accessed November 5, 2019.
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Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
Q5101
Q5111
Q5108
Q5110
Q5120
* CPT copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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