Effective with date of service April 15, 2022, the Medicaid and NC Health Choice programs cover filgrastim-ayow injection, for subcutaneous or intravenous use (Releuko®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.
Strength/Package Sizes:
Vial
- Injection: 300 mcg/mL in a single-dose vial
- Injection: 480 mcg/1.6 mL in a single-dose vial
Prefilled Syringe
- Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe
- Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe
Indicated to:
- Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever.
- Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
- Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
- Reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.
Recommended Dose:
Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML:
- Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.
Patients with cancer undergoing bone marrow transplantation:
- 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours.
Patients with congenital neutropenia:
- Recommended starting dose is 6 mcg/kg as a subcutaneous injection twice daily.
Patients with cyclic or idiopathic neutropenia:
- Recommended starting dose is 5 mcg/kg as a single subcutaneous injection daily.
See package insert for recommended dosage adjustments and timing of administration based on indication.
See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis codes required for billing is/are:
- C64.1 Malignant neoplasm of right kidney, except renal pelvis
- C64.2 Malignant neoplasm of left kidney, except renal pelvis
- C88.2 Heavy chain disease
- C88.8 Other malignant immunoproliferative diseases
- C88.9 Malignant immunoproliferative disease, unspecified
- C90.10 Plasma cell leukemia not having achieved remission
- C90.11 Plasma cell leukemia in remission
- C90.20 Extramedullary plasmacytoma not having achieved remission
- C90.21 Extramedullary plasmacytoma in remission
- C90.30 Solitary plasmacytoma not having achieved remission
- C90.31 Solitary plasmacytoma in remission
- C91.00 Acute lymphoblastic leukemia not having achieved remission
- C91.01 Acute lymphoblastic leukemia, in remission
- C91.02 Acute lymphoblastic leukemia, in relapse
- C91.10 Chronic lymphocytic leukemia of B-cell type not having achieved remission
- C91.11 Chronic lymphocytic leukemia of B-cell type in remission
- C91.12 Chronic lymphocytic leukemia of B-cell type in relapse
- C91.30 Prolymphocytic leukemia of B-cell type not having achieved remission
- C91.31 Prolymphocytic leukemia of B-cell type, in remission
- C91.32 Prolymphocytic leukemia of B-cell type, 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
- C91.50 Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission
- C91.51 Adult T-cell lymphoma/leukemia (HTLV-1-associated), in remission
- C91.52 Adult T-cell lymphoma/leukemia (HTLV-1-associated), in relapse
- C91.60 Prolymphocytic leukemia of T-cell type not having achieved remission
- C91.61 Prolymphocytic leukemia of T-cell type, in remission
- C91.62 Prolymphocytic leukemia of T-cell type, in relapse
- C91.90 Lymphoid leukemia, unspecified not having achieved remission
- C91.91 Lymphoid leukemia, unspecified, in remission
- C91.92 Lymphoid leukemia, unspecified, in relapse
- C91.A0 Mature B-cell leukemia Burkitt-type not having achieved remission
- C91.A1 Mature B-cell leukemia Burkitt-type, in remission
- C91.A2 Mature B-cell leukemia Burkitt-type, in relapse
- C91.Z0 Other lymphoid leukemia not having achieved remission
- C91.Z1 Other lymphoid leukemia, in remission
- C91.Z2 Other lymphoid 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
- C92.10 Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
- C92.11 Chronic myeloid leukemia, BCR/ABL-positive, in remission
- C92.12 Chronic myeloid leukemia, BCR/ABL-positive, in relapse
- C92.20 Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
- C92.21 Atypical chronic myeloid leukemia, BCR/ABL-negative, in remission
- C92.22 Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse
- C92.30 Myeloid sarcoma, not having achieved remission
- C92.31 Myeloid sarcoma, in remission
- C92.32 Myeloid sarcoma, in relapse
- C92.40 Acute promyelocytic leukemia, not having achieved remission
- C92.41 Acute promyelocytic leukemia, in remission
- C92.42 Acute promyelocytic leukemia, in relapse
- C92.50 Acute myelomonocytic leukemia, not having achieved remission
- C92.51 Acute myelomonocytic leukemia, in remission
- C92.52 Acute myelomonocytic leukemia, in relapse
- C92.60 Acute myeloid leukemia with 11q23-abnormality not having achieved remission
- C92.61 Acute myeloid leukemia with 11q23-abnormality in remission
- C92.62 Acute myeloid leukemia with 11q23-abnormality in relapse
- C92.90 Myeloid leukemia, unspecified, not having achieved remission
- C92.91 Myeloid leukemia, unspecified in remission
- C92.92 Myeloid leukemia, unspecified in relapse
- C92.A0 Acute myeloid leukemia with multilineage dysplasia, not having achieved remission
- C92.A1 Acute myeloid leukemia with multilineage dysplasia, in remission
- C92.A2 Acute myeloid leukemia with multilineage dysplasia, in relapse
- C92.Z0 Other myeloid leukemia not having achieved remission
- C92.Z1 Other myeloid leukemia, in remission
- C92.Z2 Other myeloid leukemia, in relapse
- C93.00 Acute monoblastic/monocytic leukemia, not having achieved remission
- C93.02 Acute monoblastic/monocytic leukemia, in relapse
- C93.10 Chronic myelomonocytic leukemia not having achieved remission
- C94.00 Acute erythroid leukemia, not having achieved remission
- C94.02 Acute erythroid leukemia, in relapse
- C94.20 Acute megakaryoblastic leukemia not having achieved remission
- C94.22 Acute megakaryoblastic leukemia, in relapse
- C94.40 Acute panmyelosis with myelofibrosis not having achieved remission
- C94.41 Acute panmyelosis with myelofibrosis, in remission
- C94.42 Acute panmyelosis with myelofibrosis, in relapse
- C94.6 Myelodysplastic disease, not classified
- D46.0 Refractory anemia without ring sideroblasts, so stated
- D46.1 Refractory anemia with ring sideroblasts
- D46.20 Refractory anemia with excess of blasts, unspecified
- D46.21 Refractory anemia with excess of blasts 1
- D46.22 Refractory anemia with excess of blasts 2
- D46.4 Refractory anemia, unspecified
- D46.9 Myelodysplastic syndrome, unspecified
- D46.A Refractory cytopenia with multilineage dysplasia
- D46.B Refractory cytopenia with multilineage dysplasia and ring sideroblasts
- D46.C Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality
- D46.Z Other myelodysplastic syndromes
- D47.1 Chronic myeloproliferative disease
- D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified
- D47.Z9 Other specified neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue
- D61.1 Drug-induced aplastic anemia
- D61.2 Aplastic anemia due to other external agents
- D61.3 Idiopathic aplastic anemia
- D61.810 Antineoplastic chemotherapy induced pancytopenia
- D61.811 Other drug-induced pancytopenia
- D61.818 Other pancytopenia
- D61.82 Myelophthisis
- D61.89 Other specified aplastic anemias and other bone marrow failure syndromes
- 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
- D72.818 Other decreased white blood cell count
- D72.819 Decreased white blood cell count, unspecified
- K12.31 Oral mucositis (ulcerative) due to antineoplastic therapy
- K12.33 Oral mucositis (ulcerative) due to radiation
- R50.81 Fever presenting with conditions classified elsewhere
- T45.1X5A Adverse effect of antineoplastic and immunosuppressive drugs, initial encounter
- T45.1X5D Adverse effect of antineoplastic and immunosuppressive drugs, subsequent encounter
- T45.1X5S Adverse effect of antineoplastic and immunosuppressive drugs, sequela
- T66.XXXA Radiation sickness, unspecified, initial encounter
- T66.XXXD Radiation sickness, unspecified, subsequent encounter
- T66.XXXS Radiation sickness, unspecified, sequela
- T80.82XA Complication of immune effector cellular therapy, initial encounter
- T80.82XS Complication of immune effector cellular therapy, sequela
- T80.89XA Other complications following infusion, transfusion and therapeutic injection, initial encounter
- T80.89XS Other complications following infusion, transfusion and therapeutic injection, sequela
- Z41.8 Encounter for other procedures for purposes other than remedying health state
- Z48.290 Encounter for aftercare following bone marrow transplant
- Z51.11 Encounter for antineoplastic chemotherapy
- Z51.12 Encounter for antineoplastic immunotherapy
- Z51.89 Encounter for other specified aftercare
- Z52.001 Unspecified donor, stem cells
- Z52.011 Autologous donor, stem cells
- Z52.091 Other blood donor, stem cells
- Z76.82 Awaiting organ transplant status
- Z76.89 Persons encountering health services in other specified circumstances
- Z91.89 Other specified personal risk factors, not elsewhere classified
- Z94.81 Bone marrow transplant status
- Z94.84 Stem cells transplant status
- Z94.84 Stem cells transplant status
- Providers must bill with HCPCS code: J3590 - Unclassified biologics
- One Medicaid and NC Health Choice unit of coverage is: 1 mcg
- The maximum reimbursement rate per unit is: $0.82
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 70121-1568-01, 70121-1568-07, 70121-1569-01, 70121-1569-07, 70121-1570-01, 70121-1570-07, 70121-1571-01, 70121-1571-07
- The NDC units should be reported as “UN1”
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
- Providers shall bill their usual and customary charge for non-340B drugs
- PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
- The fee schedule for the PADP is available on Medicaid's PADP web page.
Contact
NCTracks Call Center: 800-688-6696