CurrentCareSourcePolicy N/A

Colony Stimulating Factors — Granix (tbo‑filgrastim) Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing limits, and approved indications for Granix (tbo-filgrastim) for CareSource members; applies to prescribers and reviewers determining medical benefit coverage.

Policy Summary

PayerCareSource

PolicyColony Stimulating Factors — Granix (tbo‑filgrastim) Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateOct 9, 2024

Key ActionObtain prior authorization and document that the patient meets the policy criteria and dosing; approval requires prescription by or consultation with an oncologist or hematologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration (chemo)

5 mcg/kgcommon dosing (daily)

10 mcg/kgmax dosing (PBPC, H-ARS)

NCapplicable state

Recommended Authorization Criteria

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Cancer in a Patient Receiving Myelosuppressive Chemotherapy

Covered when ANY one of the following indication-specific criteria sets is met:

FDA-Approved Indication - Cancer receiving myelosuppressive chemotherapy

Approve for 6 months if the patient meets BOTH of the following (A and B):
- A) Patient meets ONE of the following:
  - Risk of febrile neutropenia is at least 20% based on the chemotherapy regimen.
  - Patient is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia less than 20% based on the chemotherapy regimen but has at least one risk factor for febrile neutropenia as determined by the prescriber (examples include age > 65 years receiving full chemotherapy dose intensity; chemotherapy or radiation therapy; persistent neutropenia; bone marrow involvement by tumor; recent surgery and/or open wounds; liver dysfunction (bilirubin > 2.0 mg/dL); renal dysfunction (creatinine clearance < 50 mL/min); poor performance status; HIV with low CD4 count).
  - Patient has had a neutropenic complication from a chemotherapy cycle and did not receive prophylaxis with a colony stimulating factor, and a reduced dose or frequency of chemotherapy may compromise treatment outcome.
  - Patient has febrile neutropenia after receiving chemotherapy and has at least one risk factor for poor clinical outcomes or for developing infection-associated complications according to the prescriber (examples include severe neutropenia [ANC < 100 cells/mm3]; neutropenia expected > 10 days; pneumonia or other documented infection; invasive fungal infection; hospitalization at time of fever; sepsis).
- B): Medication is prescribed by or in consultation with an oncologist or hematologist.

(Operational) Authorization duration: If criteria met, approve for 6 months.

Other Uses with Supportive Evidence

Other uses supported by evidence (authorization durations and prescribing specialist required):

Myelodysplastic Syndromes (MDS): Approve for 3 months if prescribed by or in consultation with an oncologist or hematologist; dosing up to 5 mcg/kg/day subcutaneously.

Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy: Approve for 1 month if prescribed by or in consultation with an oncologist, hematologist, or transplant specialist; dosing up to 10 mcg/kg/day subcutaneously.

Radiation Syndrome (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]): Approve for 1 month if prescribed by or in consultation with a physician with expertise in treating acute radiation syndrome; dosing up to 10 mcg/kg/day subcutaneously.

Risk Thresholds and Clinical Definitions

High‑risk threshold for febrile neutropenia

High‑risk threshold>= 20% risk of febrile neutropenia based on the chemotherapy regimen

ContextUsed to define patients for primary prophylactic CSF (Granix) when regimen-associated FN risk is at least 20%

Policy applicationMeets authorization criterion A(i) for cancer patients receiving myelosuppressive chemotherapy

Intermediate‑risk range for febrile neutropenia

Intermediate‑risk range10% to 20% risk of febrile neutropenia based on the chemotherapy regimen

Policy implicationConsider CSF prophylaxis for intermediate‑risk regimens when additional patient risk factors are present

Guideline supportNCCN/ASCO guidance recognizes CSF consideration in selected intermediate‑risk patients

Age risk example

Age risk example> 65 years (receiving full chemotherapy dose intensity)

RoleListed as an example patient‑level risk factor that may raise FN risk for intermediate‑risk regimens

Source noteUpdated in policy history to clarify ‘>65 years receiving full chemotherapy dose intensity’

Liver dysfunction definition example

Liver dysfunction definitionBilirubin > 2.0 mg/dL

UseExample risk factor for febrile neutropenia per prescriber assessment

Policy historyDefinition added/clarified in the policy history

Renal dysfunction definition example

Renal dysfunction definitionCreatinine clearance < 50 mL/min

UseExample risk factor for febrile neutropenia per prescriber assessment

Policy historyDefinition added/clarified in the policy history

Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of Granix. Approval is recommended for those who meet the policy Criteria and Dosing for the listed indications. Extended approvals are allowed if the patient continues to meet the Criteria and Dosing.

Automation: None
Approval duration: Approve for 6 months when criteria met (month = 30 days)
Prescriber requirement: Prescribed by or in consultation with a physician who specializes in the condition treated (e.g., oncologist or hematologist)

Prior Authorization

Risk-factor Based Authorization for Chemotherapy-associated Use

For chemotherapy-associated use, patients must meet specified risk-based criteria for febrile neutropenia. Approve for 6 months if the patient meets BOTH of the following: (A) regimen risk OR individual risk factors as detailed in policy, and (B) medication prescribed by or in consultation with an oncologist or hematologist.

Regimen-level high risk: ≥20% risk of febrile neutropenia based on chemotherapy regimen
Risk-factor based: receiving regimens with <20% regimen risk but with ≥1 prescriber-identified risk factor for febrile neutropenia (examples: age >65, poor performance status, bone marrow involvement, recent surgery/open wounds, hepatic dysfunction [bilirubin >2.0 mg/dL], renal dysfunction [CrCl <50 mL/min], persistent neutropenia, HIV with low CD4)
History-based: prior neutropenic complication from a chemo cycle without prior prophylaxis and where reduced chemo dose/frequency would compromise outcome
Febrile neutropenia: patients who develop febrile neutropenia and have ≥1 risk factor for poor outcomes

Documentation Required

Requests for Doses Outside Established Dosing

Requests for doses outside of the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Approval for doses or regimens not specified in the dosing section requires clinical review and justification.

Provide clinical rationale and supporting documentation for non-standard dosing (e.g., prior treatment history, body weight/BSA calculations, renal/hepatic function impact)
Case-by-case review may include consultation with Medical Director or Pharmacist and may result in approval, modification, or denial

Denial Risk

Not Recommended for Approval

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available.

Denials likely when indication or clinical scenario is not specifically supported by the policy criteria
Providers may submit additional clinical evidence for reconsideration

Key Terms and Drug

Granix (tbo‑filgrastim) — drug definition and indications

Drug name (generic)tbo‑filgrastim

Brand nameGranix

Mechanism/classGranulocyte colony‑stimulating factor (G‑CSF)

Primary indicationReduce duration of severe neutropenia in adults and pediatric patients ≥1 month with non‑myeloid malignancies receiving myelosuppressive anti‑cancer medications

Other usesStem cell mobilization and selected other indications (per guidelines)

High‑risk regimen — policy definition

DefinitionHigh‑risk chemotherapy regimen — regimen‑associated risk of febrile neutropenia is at least 20%

Policy roleQualifies patients for primary prophylactic CSF (Granix) under the FDA‑Approved Indication criteria

Relation to thresholdsEquivalent to the policy’s high‑risk threshold (≥20%) used in authorization decisions

OpenPayer

Colony Stimulating Factors — Granix (tbo‑filgrastim) Utilization Management Medical Policy

Recommended Authorization Criteria

Risk Thresholds and Clinical Definitions

Authorization & Documentation Requirements

Clinical Background

Key Terms and Drug