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.