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Medical Policy: 02.01.36
Original Effective Date: July 2009
Reviewed: October 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Granulocyte colony-stimulating factors (G-CSF), filgrastim (e.g., Neupogen®) and pegfilgrastim (e.g., Neulasta®0 and granulocyte-macrophage colony-stimulating factor (GM-CSF), sargramostim (e.g., Leukine®) are glycoproteins which act upon hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation, differentiation, commitment, and end cell functional activation. Also known as white blood cell factors, these factors are indicated to enhance recovery of hematopoietic functions in neutropenia, or decrease the incidence and severity of infection associated with drug-related myelosuppression.
Chemotherapy-induced neutropenia is a significant dose-limiting toxicity of systemic chemotherapy and is associated with substantial morbidity and mortality. Severe and febrile neutropenia often leads to chemotherapy dose reductions or treatment delays which can compromise patient outcomes. The risk of severe and febrile neutropenia is primarily based on the treatment regimen and delivered dose intensity.
According to the National Comprehensive Cancer Network (NCCN) febrile neutropenia is defined as, single temperature: ≥ 38.3 degrees C orally or ≥ 38.0 degrees C over 1 hour; neutropenia: < 500 neutrophils/mcL or < 1,000 neutrophils/mcL and a predicted decline to ≤ 500/mcL over the next 48 hours.
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Prior Approval:
Not applicable
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Policy:
Granulocyte colony-stimulating factors filgrastim (Neupogen®), pegfilgrastim (Neulasta®), and granulocyte-macrophage colony-stimulating factor sargramostim (Leukine®) may be considered medically necessary when used in patients with cancer for any of the following indications:
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Primary prophylaxis
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For the prevention of febrile neutropenia even when the risk is less than 20% in patients who have other risk factors for febrile neutropenia including any of the following:
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Patient aged 65 years or older
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Poor performance status, e.g., ECOG ≥ 2.
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Prior episode of febrile neutropenia or dose-limiting neutropenic event
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History of previous chemotherapy or radiation therapy
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Poor nutritional status
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Presence of open wound or active infections
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Recent surgery
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Pre-existing neutropenia or bone marrow involvement with tumor
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Other serious comorbidities such as poor renal function, liver dysfunction
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Secondary prophylaxis
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For patients who experienced a neutropenic complication following 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.
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Adjunctive use in febrile neutropenic patients who are at high risk for infection-associated complications, or have any of the following prognostic factors predictive of clinical deterioration:
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Expected prolonged (greater than 10 days) neutropenia
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Severe (less than 0.1 x 109/L) neutropenia
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Age 65 years or older
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Pneumonia
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Hypotension and multi-organ dysfunction (sepsis)
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Invasive fungal infection
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Sepsis syndrome
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Other clinically documented infections
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Hospitalization at the time of fever
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Prior episode of febrile neutropenia
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Prophylactic use for patient aged 65 years and older with diffuse aggressive lymphoma treated with curative chemotherapy [CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)] or more aggressive regimens. [Aside from data available in lymphoma, there is insufficient evidence to support the use of prophylactic G-CSF in patients based solely on age.]
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Acute Lymphocytic Leukemia (ALL)
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Myelodysplastic Syndrome (MDS)
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In patients receiving radiation therapy (in the absence of chemotherapy) if prolonged delays secondary to neutropenia are expected
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In the treatment of radiation injury of 3-10 Gy or above.
In addition to the aforementioned, the use of filgrastim (Neupogen®) may be considered medically necessary when used for any of the following indications:
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Chronic administration to reduce the incidence and duration of sequelae of neutropenia in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia
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Dose-dense chemotherapy regimens, especially in the treatment of node positive breast cancer, small cell lung cancer, and diffuse aggressive non-Hodgkin’s lymphoma.
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Treatment of moderate to severe aplastic anemia
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Treatment of drug-induced neutropenia, agranulocytosis
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As an alternate or adjunct to donor leukocyte infusions in patients with leukemic relapse after an allogeneic stem cell transplant
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Treatment of neutropenia associated with HIV infections/AIDS and antiretroviral therapy
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To reduce neonatal sepsis in infants with pre-eclampsia-associated neutropenia
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As an adjunct to peripheral blood stem cell transplantation to mobilize progenitor cells for collection by leukapheresis
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In adult patients after the completion of induction or repeat induction chemotherapy for acute myeloid leukemia (AML) or after the completion of consolidation chemotherapy for AML
In addition to the aforementioned, the use of sargramostim (Leukine®) may be considered medically necessary when used for any of the following indications:
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In myeloid reconstitution after allogeneic stem cell transplantation for HLA-matched related donors
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In patients over age 55 years with acute myeloid leukemia (AML) after the completion of induction or repeat induction chemotherapy
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In patients who have undergone allogeneic or autologous stem cell transplantation in whom engraftment is delayed or failed.
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Melanoma
The use of granulocyte colony-stimulating factors filgrastim (Neupogen®), pegfilgrastim (Neulasta®), and sargramostim (Leukine®) is considered not medically necessary for indications not listed above including, but not limited to the following:
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As routine prophylaxis in most chemotherapy regimens
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In patients receiving chemotherapy with a risk of febrile neutropenia less than 20% and no significant high risk for complications
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Afebrile neutropenic patients not meeting any of the above criteria
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Prior to or concurrent with chemotherapy for AML except as indicated above
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In relapsed or refractory myeloid leukemia
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Chemo sensitization of myeloid leukemias
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As adjunctive therapy to antibiotics in patients with uncomplicated febrile neutropenia, defined as:
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Fever less than 10 days duration
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No evidence of pneumonia, cellulitis, abscess, sinusitis, sepsis or invasive fungal infection
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No uncontrolled malignancies
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If the patient had received pegfilgrastim earlier in the current cycle as a prophylactic
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To increase the dose-intensity of cytotoxic chemotherapy beyond established dosage range for the regimen
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Either before and/or concurrently with chemotherapy for priming effects
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In patients receiving concomitant chemotherapy and radiation therapy, particularly involving the mediastinum
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Continued use of no response is seen within 28-42 days as patients who have failed to respond within this time frame are considered non-responders
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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J1440 Injection, filgrastim (G-CSF), 300 mcg
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J1441 Injection, filgrastim (G-CSF), 480 mcg
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J2505 Injection, pegfilgrastim, 6 mg
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J2820 Injection, sargramostim (GM-CSF), 50 mcg
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Selected References:
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Smith TJ, Khatcheressian J, Lyman G 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.
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Oken MM, Creech RH, Tormey DC et al. Toxicity and Response Criteria of the Eastern Cooperative Oncology Group. [Robert Comis, M.D., Group Chair]. Am J Clin Oncol 1982 Dec;5(6):649-55.
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Kuderer NM, Crawford H, Dale DC et al. Meta-analysis of prophylactic granulocyte colony-stimulating factor (GCSF) in cancer patients receiving chemotherapy. J Clin Oncol 2005; 23 (16S):8117.
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Dryden DM, Fassbender K, Doucette K et al. Overview of Granulocyte-colony stimulating factor for antiviral-associated neutropenia. [Technology Overview number 48]. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2008.
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Spitler LE, Grossbard ML, Ernstoff MS et al. Adjuvant Therapy of Stage III and IV Malignant Melanoma Using Granulocyte-Macrophage Colony-Stimulating Factor. J Clin Oncol. 2000;18(8):1614-1621.
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Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist. 2005; 10:427-37.
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Clark OA, Lyman GH, Castro AA et al. Colony-stimulating factors for chemotherapy-induced febrile neutropenia: a meta-analysis of randomized controlled trials. J Clin Oncol. 2005;23:4198-4214.
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Sung L, Nathan PC, Alibhai SM et al. Meta-analysis: effect of prophylactic hematopoietic colony-stimulating factors on mortality and outcomes of infection. Ann Intern Med. 2007; 147:400-11.
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Timmer-Bonte JN, Adang EM, Termeer E et al. Modeling the cost effectiveness of secondary febrile neutropenia prophylaxis during standard-dose chemotherapy. J Clin Oncol. 2008;26:290-96.
- Aapro M, Crawford J, Kamioner D. Prophylaxis of chemotherapy-induced febrile neutropenia with granulocyte colony-stimulating factors: where are we now? Support Care Cancer (2001) 18:529-41. doi 10.1007/s00520-010-0816-y.
- Lyman GH, Michels SL, Reynolds MW et al. Risk of mortality in patients with cancer who experience febrile neutropenia. Cancer. 2010 Aug 16. [Epub ahead of print]
- 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 Sep 23;11(1):404. [Epub ahead of print]
- Gawronski K, Rzepecki P, Oborska S et al. Hematologic recovery in patients who are treated with autologous stem cells transplantation taken from bone marrow after granulocyte-colony-stimulating factor stimulation. Transplant Proc. 2011 Oct; 43(8):3114-5.
- Lyman GH, Dale DC, Wolff DA et al. Acute myeloid leukemia or myelodysplastic syndrome in randomized controlled clinical trials of cancer chemotherapy with granulocyte colony-stimulating factor: a systematic review. J Clin Oncol 2010; 28:2914-24.
- Sheik H, Colaco R, Lorigan P et al. Use of G-CSF during concurrent chemotherapy and thoracic radiotherapy in patients with limited-stage small-cell lung cancer safety data from a phase II trial. Lung Cancer. 2011 Oct; 74(1):75-9. Epub 2011 Feb 26.
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Policy History:
Date Reason Action
August 2010 Annual review Policy renewed
October 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
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and, therefore, cannot guarantee any results or outcomes.
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advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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