Viva Health short-acting G-CSF Prior Auth

Coverage Criteria

Indication-based coverage

Covered when ANY of the following indication-based conditions are met and other listed requirements are satisfied:

Indication groups: Bone marrow transplant (BMT) and peripheral blood progenitor cell (PBPC) mobilization/transplant; prophylactic use in patients with solid tumors or non-myeloid malignancy meeting FN risk criteria (see prophylaxis criteria); acute myeloid leukemia (induction/consolidation or relapsed/refractory); severe chronic neutropenia; myelodysplastic syndromes meeting ESA/luspatercept-related criteria; hematopoietic acute radiation syndrome (H-ARS); CAR T-cell related neutropenia; Wilms tumor with cyclophosphamide-based regimens (Regimen M or I); pediatric aggressive mature B-cell lymphomas; treatment of chemotherapy-induced febrile neutropenia; patients with a prior neutropenic complication from the same chemotherapy regimen.

Patient must have contraindication, intolerance, or failure to Nivestym and Zarxio prior to consideration of another short-acting G-CSF where specified; see individual indication criteria for additional requirements.

Prophylactic G-CSF by febrile neutropenia (FN) risk

For prophylactic use with myelosuppressive chemotherapy, coverage requires the following nested logic:

Prophylactic use by FN risk: 1) Expected febrile neutropenia (FN) incidence > 20%; OR 2) Expected FN incidence 10–20% AND one or more patient-related risk factors; OR 3) Expected FN incidence < 10% AND two or more patient-related risk factors.FN incidence categories (>20%, 10–20%, <10%)

Use in the <10% setting with two or more risk factors is based on clinical judgment; patient-related risk factors are enumerated elsewhere in the policy.

Therapeutic use for febrile neutropenia

Treatment of chemotherapy-induced febrile neutropenia is covered when ALL of the following are met:

Therapeutic FN criteria: Patient meets the policy definition of febrile neutropenia; AND either (a) patient has been on prophylactic short-acting G-CSF prior to the FN episode (therapy should not be used concomitantly with a long-acting G-CSF), OR (b) patient has not received prophylactic G-CSF and has one or more high-risk features for infection-related complications (sepsis syndrome; age >65 years; ANC <100/mcL; expected duration of neutropenia >10 days; pneumonia or other clinically documented infection; invasive fungal infection; hospitalization at time of fever; prior episode of febrile neutropenia).Febrile neutropenia definition per policy (temperature and ANC criteria)

Document temperature and ANC as part of required clinical documentation.

Severe chronic neutropenia

Severe chronic neutropenia coverage requires ALL of the following:

Severe chronic neutropenia criteria: Absolute neutrophil count (ANC) < 500/mm3; AND diagnosis of one of: congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.ANC <500/mm3

Dosing limits for severe chronic neutropenia are specified in dosing thresholds.

Myelodysplastic Syndromes (MDS)

Myelodysplastic Syndromes (MDS) coverage for use with ESA/luspatercept follows conditional criteria:

MDS combined criteria: Symptomatic anemia without del(5q); AND lower-risk disease per IPSS-R (Very Low, Low, Intermediate); AND serum erythropoietin ≤ 500 mUnits/mL; AND used in combination with an erythropoiesis-stimulating agent (ESA); AND either (a) ring sideroblasts ≥15% (or ≥5% with SF3B1 mutation) used following no response to or relapse after luspatercept, OR (b) ring sideroblasts <15% (or <5% with SF3B1 mutation) used following no response to or relapse after ESAs alone or following no response to or relapse after luspatercept.EPO ≤500 mU/mL; ring sideroblast thresholds specified

No response is defined as <1.5 g/dL hemoglobin rise or lack of decreased RBC transfusion requirement within specified intervals (3–6 months for luspatercept; 6–8 weeks for ESAs).

Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) coverage:

AML uses: Use in patients receiving induction or consolidation chemotherapy; OR use for relapsed or refractory AML.

CAR T-cell related neutropenia

CAR T-cell related toxicity:

CAR T-cell related neutropenia: Patient is receiving CAR T-cell therapy AND is experiencing neutropenia related to that therapy.

Wilms Tumor (Nephroblastoma)

Wilms tumor:

Wilms tumor criteria: Favorable-histology Wilms tumor AND use in combination with a cyclophosphamide-based chemotherapy regimen (Regimen M or I only).

Prior neutropenic complication

Patients with prior neutropenic complications:

Prior neutropenic complication: Patient experienced a neutropenic complication from a prior cycle of the same chemotherapy regimen.

Dose-dense therapy generally requires growth factor support to maintain schedule; in the palliative setting consider dose reduction or regimen change.

Coverage governance and Medicare alignment

Coverage is governed by medical necessity and applicable Medicare NCDs/LCDs; where Medicare policies apply, those rules must be followed.

Coverage governance: Coverage determinations follow the health plan's medical necessity criteria and must comply with applicable NCDs/LCDs (for example, Palmetto GBA LCD A56748) where Medicare rules apply.

Medicare Part B rules and NCD/LCD requirements supersede when applicable; use CMS coverage database for NCD/LCD lookup.

Concomitant administration of short-acting granulocyte colony-stimulating factors with a long-acting G-CSF is not permitted. The policy explicitly states that therapy with a short-acting G-CSF "should not be used concomitantly with a long-acting G-CSF."

Medicare coverage rules may add additional requirements or limitations for outpatient (Part B) drugs. Where applicable, determinations must comply with National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) (for example, Palmetto GBA LCD A56748), and providers should consult the Medicare Coverage Database for specific NCD/LCD/LCA guidance.

Prophylactic use of short-acting G-CSF is not supported for patients with an expected febrile neutropenia (FN) risk of <10% unless the patient has two or more patient-related risk factors. Coverage for prophylaxis follows the FN risk tiers: >20% (supported), 10–20% with ≥1 risk factor (supported), and <10% only when two or more patient-related risk factors are present.

The Non‑Quantitative Treatment Limitations (NQTL) checklist indicates that PA was driven by utilization and cost considerations rather than primary concerns about safety or efficacy. The checklist lists Indication = Yes and Cost of drug = Yes, while safety/efficacy and potential misuse/abuse were not identified as primary drivers for prior authorization.

Coding and Dosing

HCPCS CodesHCPCS

J1442	Injection, filgrastim (g-csf), excludes biosimilars, 1 mcg: 1 billable unit = 1 mcg
Q5110	Injection, filgrastim-aafi, biosimilar, (Nivestym), 1 mcg: 1 billable unit = 1 mcg
Q5101	Injection, filgrastim-sndz, biosimilar, (Zarxio), 1 mcg: 1 billable unit = 1 mcg
J1447	Injection, tbo-filgrastim (Granix), 1 mcg: 1 billable unit = 1 mcg
Q5125	Injection, filgrastim-ayow, biosimilar, (Releuko), 1 mcg; 1 billable unit = 1 mcg
Q5148	Injection, filgrastim-txid (nypozi), biosimilar, 1 microgram; 1 billable unit = 1 mcg

NDCs (examples listed)NDC

55513-0530-xx	Neupogen 300 mcg single-dose vial (NDC pattern listed)
00069-0293-xx	Nivestym 300 mcg single-dose vial (NDC pattern listed)
61314-0246-xx	Zarxio 300 mcg single-dose vial (NDC pattern listed)
70121-1569-xx	Releuko 300 mcg single-dose vial (NDC pattern listed)
63459-0918-xx	Granix 300 mcg single-dose vial (NDC pattern listed)
72374-0101-xx	Nypozi 300 mcg single-dose prefilled syringe (NDC pattern listed)

Covered ICD-10 Diagnosis CodesICD-10Covered

C64.1	Malignant neoplasm of right kidney, except renal pelvis.
C64.2	Malignant neoplasm of left kidney, except renal pelvis.
C64.9	Malignant neoplasm of unspecified kidney, except renal pelvis.
C65.1	Malignant neoplasm of right renal pelvis.
C65.2	Malignant neoplasm of left renal pelvis.
C65.9	Malignant neoplasm of unspecified renal pelvis.
C83.30	Diffuse large B-cell lymphoma, unspecified site.
C83.31	Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck.
C83.32	Diffuse large B-cell lymphoma, intrathoracic lymph nodes.
C83.33	Diffuse large B-cell lymphoma, intra-abdominal lymph nodes.

1–10 of 91

1/10

Referenced LCD/LCAmixed

A56748

Palmetto GBA Local Coverage Determination: White Cell Colony Stimulating Factors

Dosing limits / example doses

Severe chronic neutropenia (congenital) — max units1560 billable units per day (example dose: congenital neutropenia 6 mcg/kg twice daily)

BMT / PBPC / H-ARS — max units1200 billable units per day (example dose: 10 mcg/kg daily for up to 14 days)

All other indications — max units600 billable units per day (example dose: 5 mcg/kg daily for up to 14 days)

NQTL factors considered

Indication consideredYes — indication was a primary factor in applying prior authorization

Safety and efficacy considered

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorizations are valid for 4 months and may be renewed every 4 months thereafter.

Prior authorization initial validity = 4 months.
Renewal = may be renewed every 4 months.

Note

Utilization Management / NQTL Considerations

Prior authorization and utilization management are applied based on Non‑Quantitative Treatment Limitations (NQTL) considerations and drug cost. Indication and drug cost were identified as drivers when designing and applying prior authorization to this drug/drug group.

NQTL factors considered include indication, safety/efficacy, misuse/abuse potential, and cost.
Plan concluded: Indication = consider for PA; Cost of drug = consider for PA; Safety and misuse = not prioritized.

Line of Therapy

first-line

First-line AML setting: Used in patients receiving induction/consolidation chemotherapy or for relapsed/refractory disease (AML).

mixed

Mixed uses cited: G-CSFs cited for prophylaxis of chemotherapy-induced febrile neutropenia, treatment of severe chronic neutropenia, and for stem cell mobilization in autologous/allogeneic transplantation based on randomized trials and biosimilar studies.

References include biosimilar and filgrastim clinical studies.

Covered Regimens and Indications

Regimen	Indication	Coverage Status
Cyclophosphamide-based (Regimen M or I)
Wilms tumor (favorable histology) when used in combination with a cyclophosphamide-based chemotherapy regimen (Regimen M or I only).
Coverage limited to Regimen M or I cyclophosphamide-based regimens as specified in policy.

Agent / Group	Studied Use	Coverage Status
Filgrastim and filgrastim biosimilars (examples cited: XM02/Tevagrastim, Tbo-Filgrastim, Nivestym)
Stem cell mobilization for autologous/allogeneic transplantation and reduction in duration of severe neutropenia and incidence of febrile neutropenia during chemotherapy as demonstrated in cited trials and analyses.
Coverage applies when used for the studied indications (mobilization and reduction of severe neutropenia/FN) consistent with the cited evidence.

Definitions

Febrile neutropenia

Fever threshold (single reading)Oral temperature ≥38.3 °C

Fever threshold (sustained)Temperature ≥38.0 °C sustained over 1 hour

Neutropenia thresholdAbsolute neutrophil count (ANC) <500 neutrophils/mcL OR ANC <1,000 neutrophils/mcL with predicted decline to ≤500 within 48 hours

Biosimilar G-CSF

Equivalence / noninferiority of filgrastim biosimilarsBiosimilar filgrastim products (e.g., XM02/Tevagrastim, Tbo-filgrastim, Nivestym) are shown in cited studies to be equivalent or noninferior to reference filgrastim for reducing duration of severe neutropenia and enabling stem cell mobilization

Mobilization and engraftment dataStudies (e.g., Elayan et al., Tbo-Filgrastim vs filgrastim) support biosimilar use for PBPC mobilization and neutrophil engraftment

Background

Short-acting G-CSFs (filgrastim and biosimilars) are used to reduce the duration and severity of neutropenia associated with cytotoxic chemotherapy, to mobilize peripheral blood progenitor cells for transplantation, and to treat or prevent neutropenia in a range of hematologic and oncologic indications. The policy lists common uses including peripheral blood progenitor cell (PBPC) mobilization and transplant, prophylaxis in patients receiving myelosuppressive chemotherapy, treatment of chemotherapy-induced febrile neutropenia, management of severe chronic neutropenia, supportive care in acute myeloid leukemia, CAR T-cell–related neutropenia, Wilms tumor regimens, and select pediatric B‑cell lymphomas.

Revision History

2025-11-04policy_reviewLatest

Policy last reviewed; routine review date recorded in document metadata.

NQTL_checklist_added

NQTL factor checklist documenting consideration of indication and cost as drivers for prior authorization was included in Appendix A.

prior_authorization_timing_documented

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Short-Acting Granulocyte Colony Stimulating Factors (SAG-CSF)