Download Granulocyte Colony Stimulating Factors

Granulocyte Colony Stimulating Factors
Last Review Date: February 26, 2016
Number: MG.MM.PH.15av2
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Definition
Granulocyte colony stimulating factors are used to stimulate the production and release of white blood
cells by the bone marrow.
Guideline
A. Filgrastim (Neupogen) is considered medically necessary for any of the following conditions:
1. Primary prophylaxis of febrile neutropenia (FN) in individuals with a high risk of FN (≥
20%) or with intermediate risk (10–20%) with presence of risk factors (e.g., age > 65,
poor functional/nutritional status, serious co-morbidities)
2.
Secondary prophylaxis of febrile neutropenia in individuals who experienced a
neutropenic complication from a prior cycle of chemotherapy (for which primary
prophylaxis was not received), in which a reduced dose may compromise disease-free or
overall survival or treatment outcome
3.
Adjunctive treatment of members with febrile neutropenia and high risk for infectionassociated complications
4.
Myoablative chemotherapy prior to allogenic or autologous bone marrow
transplantation
5.
Acute myeloid leukemia (AML) following consolidation or induction chemotherapy
6.
Hairy cell leukemia with severe neutropenia (absolute neutrophil count < 500/mm3)
7.
Individuals with acute lymphoblastic leukemia (ALL) after completion of the first few
days of chemotherapy of the initial induction or first post-remission course.
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8.
In an individual with myelodysplastic syndromes (MDS) with severe neutropenia (ANC <
500/mm3) or experiencing recurrent infections
9.
Presence of severe aplastic anemia
10. Chronic administration in symptomatic members with congenital neutropenia, cyclic
neutropenia or idiopathic neutropenia
11. Treatment for neutropenia associated with human immunodeficiency virus (HIV)
infection and antiretroviral therapy
12. In members receiving radiation therapy in the absence of chemotherapy if prolonged
delays secondary to neutropenia are expected
13. Glycogen storage disease type 1b members with low neutrophils
14. Neutropenia associated with HIV infection and antiretroviral therapy
15. Following total body radiation > 2 Gy
16. Members receiving radiation therapy alone if prolonged delays secondary to
neutropenia are expected
17. After autologous hematopoietic progenitor stem cell transplant (HPCT/HSCT)
18. To mobilize progenitor cells into peripheral blood for collection by leukapheresis, as an
adjunct to peripheral blood/hematopoietic stem cell transplantation (PBSCT/PHSCT)
19. Use as an alternate or adjunct to donor leukocyte infusions (DLI) in members with
leukemic relapse after an allogeneic hematopoietic stem cell transplant
B. Peg-filgastrim (Neulasta) is considered medically necessary for any of the following conditions:
1. Primary prophylaxis of febrile neutropenia (FN) in members with a high risk of FN (>
20%) or with intermediate risk (10–20%) with presence of risk factors (e.g., age > 65,
poor functional/nutritional status, serious co-morbidities)
2.
Secondary prophylaxis of febrile neutropenia in individuals who experienced a
neutropenic complication from a prior cycle of chemotherapy (for which primary
prophylaxis was not received), in which a reduced dose may compromise disease-free or
overall survival or treatment outcome
3.
Adjunctive treatment of members with febrile neutropenia and high risk for infectionassociated complications
4.
In a member with acute lymphocytic leukemia (ALL) after completion of the first few
days of initial induction chemotherapy or first post-remission course of chemotherapy
5.
After autologous hematopoietic progenitor stem cell transplant (HPCT/HSCT)
C. Sargramostim (Leukine®) is considered medically necessary for any of the following conditions:
1. Myeloid reconstitution after autologous or allogeneic bone marrow transplant (BMT)
2.
Peripheral blood progenitor cell (PBPC) mobilization and transplant
3.
In a member who experienced a neutropenic complication from a prior cycle of the
same chemotherapy
4.
Acute myeloid leukemia (AML) following induction or consolidation chemotherapy
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5.
Bone marrow transplantation (BMT) failure or engraftment delay
Limitations/Exclusions
Granulocyte colony stimulating factors (filgrastim and peg-filgrastim) are considered experimental or
investigational for all other uses
Revision History
2/26/2016: Added sargramostim (Leukine) clinical criteria.
Applicable Procedure Codes
J1442
Injection, filgrastim (G-CSF), 1 microgram, excludes biosimilars, 1 microgram
J1447
Injection, tbo-filgrastim, 1 microgram
J2505
Injection, pegfilgrastim, 6 mg
J2820
Injection, sargramostim (GM-CSF), 50 mcg
38240
Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor
38241
Hematopoietic progenitor cell (HPC); autologous transplantation
Applicable ICD-10 Diagnosis Codes
B20
Human immunodeficiency virus [HIV] disease
C91.00
Acute lymphoblastic leukemia not having achieved remission
C91.01
Acute lymphoblastic leukemia, in remission
C91.02
Acute lymphoblastic leukemia, in relapse
C91.40
Hairy cell leukemia not having achieved remission
C91.41
Hairy cell leukemia, in remission
C91.42
Hairy cell leukemia, in relapse
C92.00
Acute myeloblastic leukemia, not having achieved remission
C92.01
Acute myeloblastic leukemia, in remission
C92.02
Acute myeloblastic leukemia, in relapse
D46.9
Myelodysplastic syndrome, unspecified
D70.0
Congenital agranulocytosis
D70.1
Agranulocytosis secondary to cancer chemotherapy
D70.2
Other drug-induced agranulocytosis
D70.3
Neutropenia due to infection
D70.4
Cyclic neutropenia
D70.8
Other neutropenia
D70.9
Neutropenia, unspecified
E74.00
Glycogen storage disease, unspecified
E74.01
von Gierke disease
Z52.011
Autologous donor, stem cells
Z94.6
Bone transplant status
Z94.81
Bone marrow transplant status
Z94.84
Stem cells transplant status
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References
1.
Aapro MS, Bohlius J, Cameron 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.
2.
Bath PM, Sprigg N, England T. Colony stimulating factors (including erythropoietin, granulocyte colony
stimulating factor and analogues) for stroke. Cochrane Database Syst Rev. 2013; (6):CD005207.
3.
Bohlius J, Reiser M, Schwarzer G, Engert A. Granulopoiesis-stimulating factors to prevent adverse effects in the
treatment of malignant lymphoma. Cochrane Database Syst Rev. 2004; (3):CD003189.
4.
Clark OA, Lyman G, Castro AA, et al. Colony stimulating factors for chemotherapy induced febrile neutropenia.
Cochrane Database Sys Rev. 2003; (3):CD003039.
5.
Cooper KL, Madan J, Whyte S, et al. Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis
following chemotherapy: systematic review and meta-analysis. BMC Cancer. 2011; 11:404.
6.
Farese AM, Cohen MV, Katz BP, et al. Filgrastim improves survival in lethally irradiated nonhuman primates.
Radiat Res. 2013; 179(1):89-100.
7.
Flowers CR, Seidenfeld J, Bow EJ, et al. Antimicrobial prophylaxis and outpatient management of fever and
neutropenia in adults treated for malignancy: American Society of Clinical Oncology clinical practice guideline. J
Clin Oncol. 2013; 31(6):794-810.
8.
Freyer G, Jovenin N, Yazbek G, et al. Granocyte-colony stimulating factor (G-CSF) has significant efficacy as
secondary prophylaxis of chemotherapy-induced neutropenia in patients with solid tumors: results of a
prospective study. Anticancer Res. 2013; 33(1):301-307.
9.
Kaplan JE, Benson C, Holmes KH, et al.; Centers for Disease Control and Prevention (CDC), National Institutes of
Health, HIV Medicine Association of the Infectious Diseases Society of America. Guidelines for prevention and
treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from CDC, the
National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America.
MMWR Recomm Rep. 2009; 58(RR-4):1-207.
10. Leukine [package insert]. Seattle, WA; Bayer Pharmaceuticals, Inc; April 2013. Accessed February 2016.
11. National Comprehensive Cancer Network (NCCN®) Drugs & Biologic Compendium® © 2015 National
Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org.
Accessed on September 13th, 2015.
12. Specialty matched clinical peer review.