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Hematopoietic Colony-Stimulating Factors (CSFs)

Trple S considers short-acting granulocyte colony stimulating factors (G-CSFs), medically necessary for prevention of neutropenia in persons with cancer receiving myelosuppressive chemotherapy when the following criteria are met:I.    The short-acting G-CSF will not be used in combination with other colony stimulating factors within any chemotherapy cycle; and
II.    The member will not be receiving concurrent chemotherapy and radiation therapy; and
III.    One of the following criteria is met
A.    The short-acting G-CSF will be used for primary prophylaxis in individuals with a solid tumor or non-myeloid malignancies who have received, is currently receiving, or will be receiving myelosuppressive chemotherapy that is expected to result in:
1.    20% or higher incidence of febrile neutropenia (FN) (see Appendix); or
2.    10 – 19% risk of FN (see Appendix)
Note: In the absence of special circumstances, most commonly used regimens have risks of FN of less than 20 %.  When available, alternative regimens offering equivalent efficacy, but not requiring CSF support, should be utilized (Smith et al, 2006).
B.    The short-acting G-CSF will be used for secondary prophylaxis in members with solid tumors or non-myeloid malignancies who experienced a febrile neutropenic complication or a dose-limiting neutropenic event (a nadir or day of treatment count impacting the planned dose of chemotherapy) from a prior cycle of similar chemotherapy, with the same dose and schedule planned for the current cycle (for which primary prophylaxis was not received).
Note: Colony-stimulating factors should not be routinely used for afebrile neutropenia (Smith et al, 2006).

C.    The short-acting G-CSF will be used for treatment of febrile neutropenia (FN).
Tripe S considers short-acting G-CSF products medically necessary for the following indications:
I.    Acute Myeloid Leukemia
II.    Agranulocytosis (non-chemotherapy drug-induced)
III.    Aplastic anemia
IV.    CAR T-cell-related toxicities: Supportive care for neutropenic persons with CAR T-cell-related toxicities
V.    Chronic Myeloid Leukemia: Members with chronic myeloid leukemia (CML) for treatment of persistent neutropenia due to tyrosine kinase inhibitor therapy
VI.    Glycogen Storage Disease (GSD) Type 1: Individuals with GSD Type 1 for treatment of low neutrophil counts
VII.    Hairy Cell Leukemia: Members with hairy cell leukemia with neutropenic fever following chemotherapy
VIII.    Hematopoietic Syndrome of Acute Radiation Syndrome – Treatment for radiation-induced myelosuppression following a radiological/nuclear incident
IX.    Myelodysplastic syndrome (anemia or neutropenia)
X.    Neutropenia related to HIV/AIDS
XI.    Neutropenia related to renal transplantation
XII.    Severe chronic neutropenia (congenital, cyclic, or idiopathic)
XIII.    Stem cell transplantation-related indications.

Trple S considers long-acting granulocyte colony stimulating factors (G-CSFs), pegfilgrastim (Neulasta), pegfilgrastim-jmdb (Fulphila), Nyvepria (pegfilgrastim -apgf), pegfilgrastim-cbqv (Udenyca), and pegfilgrastim-bmez (Ziextenzo) medically necessary for prevention of neutropenia in persons with cancer receiving myelosuppressive chemotherapy when the following criteria are met:
I.    The long-acting G-CSF will not be used in combination with other colony stimulating factors within any chemotherapy cycle; and
II.    The member will not be receiving concurrent chemotherapy and radiation therapy; and
III.    The requested medication will not be administered with weekly chemotherapy regimens; and
IV.    One of the following criteria is met
A.    The long-acting G-CSF will be used for primary prophylaxis in individuals with a solid tumor or non-myeloid malignancies who have received, is currently receiving, or will be receiving myelosuppressive chemotherapy that is expected to result in:
1.    20% or higher incidence of febrile neutropenia (FN) (see Appendix); or
2.    10 – 19% risk of FN (see Appendix)
Note: In the absence of special circumstances, most commonly used regimens have risks of FN of less than 20 %.  When available, alternative regimens offering equivalent efficacy, but not requiring CSF support, should be utilized (Smith et al, 2006).
B.    The long-acting G-CSF will be used for secondary prophylaxis in members with solid tumors or non-myeloid malignancies who experienced a febrile neutropenic complication or a dose-limiting neutropenic event (a nadir or day of treatment count impacting the planned dose of chemotherapy) from a prior cycle of similar chemotherapy, with the same dose and schedule planned for the current cycle (for which primary prophylaxis was not received).
Note: Colony-stimulating factors should not be routinely used for afebrile neutropenia (Smith et al, 2006).
C.    The short-acting G-CSF will be used for treatment of febrile neutropenia (FN).
Triple S considers long-acting G-CSF products medically necessary for the following indications:
I.    Chronic Myeloid Leukemia – Members with chronic myeloid Leukemia (CML) for treatment of persistent neutropenia due to tyrosine kinase inhibitor therapy
II.    Hairy cell leukemia – Members with hairy cell leukemia with neutropenic fever following chemotherapy
III.    Hematopoietic Syndrome of Acute Radiation Syndrome – Treatment for radiation-induced myelosuppression following a radiological/nuclear incident
IV.    Stem cell transplantation-related indications.

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