Granulocyte Colony-Stimulating Factors (Medicaid Expansion)

Policy ID: ME-I-88-025-01

Section: Injections

Effective Date: January 01, 2023

Last Reviewed: November 29, 2022

Applies To: Medicaid Expansion Only

Description

The class of drugs known as granulocyte colony stimulating factors (G-CSFs) include: filgrastim (Neupogen®), filgrastim-sndz, (Zarxio®), filgrastim-aafi (Nivestym®), filgrastim-ayow (Releuko) pegfilgrastim (Neulasta®) (Neulasta® Onpro®), pegfilgrastim-jmdb (Fulphila™), pegfilgrastim-cbqv (Udenyca™), pegfilgrastim-bmez (Ziextenzo™), pegfilgrastim-apgf (Nyvepria™), pegfilgrastim-fpgk (Stimufend®), pegfilgrastim-pbbk (Fylnetra®) ®), tbo-filgrastim (Granix®) and eflapegrastim-xnst (Rolvedon™). Sargramostim (Leukine®) is a granulocyte-macrophage colony-stimulating factor (GM-CSF).

Febrile neutropenia (FN) is defined as a single temperature equal to or greater than 38.3°C, or a temperature equal to or greater than 38.0°C over one (1) hour, and neutrophils less than 500 mcL.

G-CSFs are a blood growth factor that stimulates the bone marrow to produce more infection-fighting white blood cells known as neutrophils. These neutrophils are then released into the blood stream where they aid in fighting infection. When neutrophil levels drop and an individual becomes neutropenic, the body is less able to fight off infection. Individuals at high risk to develop these types of conditions may be clinically indicated for the administration of G-CSFs.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Note: Risk assessment for use of G-CSFs includes (not an all-inclusive list) disease type, chemotherapy regimen (high-dose, dose-dense, or standard-dose), risk factors, and treatment intent (curative/adjuvant vs. palliative). Independent clinical judgment should be exercised based on the individual’s situation.

Filgrastim (Neupogen) may be considered medically necessary for ANY of the following indications:

Individuals with nonmyeloid malignancies receiving myelosuppressive anticancer drug therapy associated with significant incidence of severe neutropenia with fever to decrease incidence of infection; or
Individuals with acute myeloid leukemia (AML) following induction or consolidation chemotherapy to reduce the time to neutrophil recovery and duration of fever; or
Individuals with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) to reduce duration of neutropenia and neutropenia-related clinical sequelae; or
Individuals undergoing autologous peripheral blood progenitor cell collection and therapy for mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis; or
For chronic administration in individuals with severe chronic neutropenia to reduce incidence and duration of sequelae of neutropenia in symptomatic individuals with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia; or
Individuals acutely exposed to myelosuppressive doses of radiation in hematopoietic acute radiation syndrome (H-ARS) to increase survival; or

Compendia Sources

Filgrastim (Neupogen) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Filgrastim (Neupogen) not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Code

J1442

Filgrastim-sndz (Zarxio) and filgrastim-aafi (Nivestym) may be considered medically necessary for ANY of the following:

To decrease the incidence of infection as manifested by febrile neutropenia in individuals with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; or
For individuals with AML following induction or consolidation chemotherapy to reduce the time to neutrophil recovery and duration of fever following treatments; or
For individuals with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT to reduce duration of neutropenia and neutropenia-related clinical sequelae; or
For individuals undergoing autologous peripheral blood progenitor cell collection and therapy for mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis; or
For chronic administration in individuals with severe chronic neutropenia to reduce incidence and duration of sequelae of neutropenia in symptomatic individuals with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia; or

Compendia Sources

Filgrastim-sndz (Zarxio) and filgrastim-aafi (Nivestym) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Filgrastim-sndz (Zarxio) and filgrastim-aafi (Nivestym) not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

Q5101

Q5110

Tbo-filgrastim (Granix) may be considered medically necessary for ANY of the following:

To reduce the duration of severe neutropenia in adult and pediatric individuals one (1) month and older with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of FN; or

Compendia Sources

Tbo-filgrastim (Granix) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Tbo-filgrastim (Granix) not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

J1447

Filgrastim-ayow (Releuko) may be considered medically necessary for ANY of the following:

For individuals with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever to reduce the incidence of infection‚ as manifested by febrile neutropenia; or
For individuals with AML following induction or consolidation chemotherapy treatment to reduce the time to neutrophil recovery and the duration of fever; or
For individuals with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT to reduce duration of neutropenia and neutropenia-related clinical sequelae; or
For chronic administration in individuals with severe chronic neutropenia to reduce incidence and duration of sequelae of neutropenia in symptomatic individuals with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia; or

Compendia Sources

Filgrastim-ayow (Releuko) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Filgrastim-ayow (Releuko) not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

Q5125

Pegfilgrastim (Neulasta) and (Neulasta Onpro) may be considered medically necessary for ANY of the following:

Individuals with nonmyeloid malignancies receiving malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of FN to decrease the incidence of infection; or
Individuals acutely exposed to myelosuppressive doses of radiation in H-ARS to increase survival; or

Compendia Sources

Pegfilgrastim (Neulasta) and (Neulasta Onpro) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Pegfilgrastim (Neulasta) and (Neulasta Onpro) not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

J2506

96377

Pegfilgrastim-jmdb (Fulphila), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-cbqv (Udencya), pegfilgrastim-apgf (Nyvepria), pegfilgrastim-fgpk (Stimufend), pegfilgrastim-pbbk (Fylnetra) and eflapegrastim-xnst (Rolvedon) may be considered medically necessary for ANY the following:

To decrease the incidence of infection as manifested by febrile neutropenia in individuals with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; or

Compendia Sources

Pegfilgrastim-jmdb (Fulphila), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-cbqv (Udencya), pegfilgrastim-apgf (Nyvepria), pegfilgrastim-fgpk (Stimufend), and pegfilgrastim-pbbk (Fylnetra) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Note: Pegfilgrastim-jmdb (Fulphila), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-cbqv (Udencya), pegfilgrastim-apgf (Nyvepria) pegfilgrastim-fgpk (Stimufend), pegfilgrastim-pbbk (Fylnetra), and eflapegrastim-xnst (Rolvedon) are not indicated for the mobilization or peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Pegfilgrastim-jmdb (Fulphila), pegfilgrastim-bmez (Ziextenzo), pegfilgrastim-cbqv (Udencya), pegfilgrastim-apgf (Nyvepria), pegfilgrastim-fgpk (Stimufend), or pegfilgrastim-pbbk (Fylnetra) not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

Q5108

Q5111

Q5120

Q5122

J3590

Sargramostim (Leukine) may be considered medically necessary for ANY of the following indications:

Individuals 55 years and older with AML following induction chemotherapy to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death; or
Adult individuals undergoing mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation; or
Individuals two (2) years of age or older for the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation; or
Individuals two (2) years or age or older for the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation; or
Individuals two (2) years or age or older for treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation; or
Individuals acutely exposed to myelosuppressive doses of radiation in H-ARS to increase survival; or

Compendia Sources

Sargramostim (Leukine) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

Sargramostim (Leukine) not meeting the criteria as indicated in this policy is considered not medically necessary.

Procedure Codes

J2820

The use of G-CSFs are considered not medically necessary for ANY of the following:

For uses not meeting the criteria above; or
As prophylaxis for FN, except when criteria above are met; or
As treatment of neutropenia in individuals who are afebrile, except when criteria above are met; or
As adjunctive therapy in individuals with uncomplicated FN, defined as: fever less than ten (10) days duration, no evidence of pneumonia, cellulitis, abscess, sinusitis, hypotension, multi-organ dysfunction, or invasive fungal infection; and no uncontrolled malignancies; or
Chemo sensitization of myeloid leukemias; or
As prophylaxis for FN during concomitant chemotherapy and radiation therapy; or
Continued use if no response is seen within 28-42 days (individuals who have failed to respond within this time frame are considered non-responders).

Procedure Codes

J1442

J1447

J2506

J2820

Q5101

Q5108

Q5110

Q5111

Q5120

Q5122

Q5125

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

*Note: Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), and WPSS (Very Low, Low, Intermediate).

Note: Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 or Q5110 to report the biosimilarity of filgrastim. Pegfilgrastim (Neulasta), J2506, excludes biosimilar reference in its definition and should therefore be reported with code Q5108, Q5111, or Q5120 to report the biosimilarity of pegfilgrastim.

The safety and efficacy of sargramostim (Leukine) have not been assessed in individuals with AML less than 55 years of age.

Liquid solutions containing benzyl alcohol (including liquid sargramostim or lyophilized Leukine reconstituted with bacteriostatic water for injection, USP (0.9% benzyl alcohol)) should not be administered to neonates.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Code J1442

B20

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

C93.00

C93.02

C93.10

C94.00

C94.02

C94.20

C94.22

D46.0

D46.1

D46.20

D46.21

D46.22

D46.4

D46.9

D46.A

D46.B

D46.C

D46.Z

D47.1

D47.4

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Covered Diagnosis Codes for Procedure Code Q5101

B20

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

C93.10

D46.0

D46.1

D46.20

D46.21

D46.22

D46.4

D46.9

D46.A

D46.B

D46.C

D46.Z

D47.1

D47.4

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Covered Diagnosis Codes for Procedure Code Q5110

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Covered Diagnosis Codes for Procedure Code J2506, 96377

D61.810

D61.811

D61.818

D70.1

D70.2

D70.3

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Covered Diagnosis Codes for Procedure Codes Q5108, Q5111, Q5120, Q5122, J3590

D61.810

D61.811

D61.818

D70.1

D70.2

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

Z41.8

Z51.11

Z51.12

Z51.89

Z76.89

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Covered Diagnosis Codes for Procedure Code J1447

C93.10

D46.0

D46.1

D46.20

D46.21

D46.4

D46.9

D46.A

D46.B

D46.Z

D61.810

D61.811

D61.818

D70.1

D70.2

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Covered Diagnosis Codes for Procedure Code J2820

C92.00

C92.02

C92.10

C92.40

C92.42

C92.50

C92.52

C92.60

C92.62

C92.90

C92.92

C92.A0

C92.A2

C93.10

D61.1

D61.2

D61.3

D61.810

D61.811

D61.818

D61.89

D70.0

D70.1

D70.2

D70.3

D70.4

D70.8

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1XXA

W88.1XXD

W88.1XXS

W88.8XXA

W88.8XXD

W88.8XXS

Covered Diagnosis Codes for Procedure Code Q5125

C92.00

C92.02

C92.50

C92.52

C92.60

C92.62

C92.A0

C92.A2

C93.00

C93.02

C93.10

D61.81

D70.1

D70.2

D70.9

T45.1X5A

T45.1X5D

T45.1X5S

T66.XXXA

T66.XXXD

T66.XXXS

W88.1

W88.8

T80.82XA

T80.82XS

T80.89XA

T80.89XS

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-29-2022 - Effective January 01, 2023

Adopted New policy
For Medicaid Expansion only
Replacing I-88 Granulocyte Colony-Stimulating Factors

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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Granulocyte Colony-Stimulating Factors (Medicaid Expansion)

Description

Criteria

Procedure Code

Procedure Codes

Procedure Codes

Procedure Codes

Procedure Codes

Procedure Codes

Procedure Codes

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer