CurrentEmblemHealthPolicy MG.MM.PH.379

Colony Stimulating Factors: Stimufend (pegfilgrastim-fpgk) subcutaneous injection

Policy governs medical necessity criteria, dosing, coding, and prior authorization requirements for Stimufend (pegfilgrastim-fpgk) subcutaneous injection for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyColony Stimulating Factors: Stimufend (pegfilgrastim-fpgk) subcutaneous injection

Policy CodePolicy MG.MM.PH.379

Change TypeRevised clinical criteria and dosing

Effective Date

Next Review DateMar 18, 2025

Key ActionSubmit clinical evidence that the member meets the policy's medical necessity criteria and document failure or contraindication to preferred agents when applicable.

SourceLink

POLICY UPDATE CHANGES

Updated risk factors (patient co-morbidities) for febrile neutropenia and added criterion allowing prophylactic use when expected FN risk is <10% with two or more patient-related risk factors.

Updated dosing limits and dosing chart and added indication and dosing for patients acutely exposed to myelosuppressive radiation.

Updated applicable procedure code list to include Q5127 for Stimufend.

6 monthsauthorization length

6 mgper-dose adult dose

Q5127HCPCS code

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Medical Necessity and Coverage Criteria

Initial Therapy / Prophylactic Use

Stimufend is considered medically necessary when ONE of the following high-level conditions is met AND use is consistent with the detailed medical necessity criteria below:

High-level approval pathways: Any one of the following: continuing previously established Stimufend therapy for the current chemotherapy regimen; patient has failed treatment with Neulasta and Udenyca or both are contraindicated; member lacks access to or benefits for home health services; member is expected to receive G-CSF for 5 consecutive days or more; Stimufend is used in combination with a specified dose-dense chemotherapy regimen (dose-dense MVAC for bladder cancer; dose-dense AC followed by T for breast cancer; CHOP-14 for non-Hodgkin lymphoma).

Neulasta and Udenyca are preferred agents; step therapy preference applies (provider should document failure or contraindication where required).

Prophylactic use criteria

High FN risk: Expected incidence of febrile neutropenia >20%.>20%
See NCCN Hematopoietic Growth Factors guideline for regimen-specific FN percentages.
Intermediate FN risk plus risk factors: Expected FN incidence 10%–20% AND one or more patient-related risk factors (see Risk-Factor Definitions).10–20%
At least one patient-related risk factor required.
Low FN risk with multiple risk factors: Expected FN incidence <10% AND two or more patient-related risk factors (see Risk-Factor Definitions).<10%
Use in this setting is based on clinical judgment.

Dose-dense regimen requirement: Dose-dense therapy generally requires growth factor support to maintain dose intensity and schedule.

In the palliative setting consider dose reduction or regimen change rather than growth factor support.

Risk-Factor Definitions

Patient-related risk factors used to count toward criteria:

Patient risk factors (count toward 'one or more' or 'two or more' requirements): Age >65 years receiving full dose intensity chemotherapy; persistent neutropenia (ANC <1000/mm3); prior exposure to chemotherapy or radiation therapy; bone marrow involvement by tumor; condition that can increase risk of serious infection (e.g., advanced HIV/AIDS with low CD4 counts); poor performance status; renal dysfunction (creatinine clearance <50 mL/min); liver dysfunction (elevated bilirubin >2.0 mg/dL); chronic immunosuppression in the post-transplant setting (including organ transplant).

These risk factors are used to satisfy the 'one or more' requirement for intermediate FN risk and the 'two or more' requirement for low FN risk as specified in the prophylactic criteria.

Dosing / Administration

Administration and dosing limits:

Timing: Do not administer within 14 days before and do not administer within 24 hours after cytotoxic chemotherapy.

Acute radiation exposure dosing: 6 mg subcutaneously once weekly for 2 doses (use weight-based dosing for pediatric patients <45 kg).

Per dosing limits: 6 mg max weekly for 2 doses (12 billable units weekly x 2 doses).

All other indications dosing: 6 mg subcutaneously once per chemotherapy cycle and no more frequently than every 14 days (use weight-based dosing for pediatric patients <45 kg).

Maximum dosing interval: no more frequently than every 14 days (12 billable units per 14 days).

Regimen	Cancer type	Chemotherapy agents where specified	Coverage status
Dose-dense MVAC	Bladder cancer	Methotrexate; vinblastine; doxorubicin; cisplatin	Covered
Dose-dense AC → T	Breast cancer	Doxorubicin; cyclophosphamide followed by paclitaxel	Covered
CHOP-14 (dose-dense)	Non-Hodgkin lymphoma	Cyclophosphamide; doxorubicin; vincristine; prednisone	Covered

Stimufend is not considered medically necessary for indications other than those explicitly listed in this policy due to insufficient evidence of therapeutic value. See the policy's Limitations/Exclusions for details.

Any use of Stimufend outside the specified indications and medical necessity criteria in this policy is not medically necessary. Refer to the Limitations/Exclusions section for the complete list of non-covered uses.

inv-15: Febrile neutropenia — definition

Temperature thresholdSingle temperature ≥38.3°C OR ≥38.0°C sustained over 1 hour

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

Clinical contextDefinition applies to infection risk in patients with non‑myeloid malignancies receiving myelosuppressive anti‑cancer drugs

inv-16: Patient who experienced a neutropenic complication — clarifying note

DefinitionPatient who experienced a neutropenic complication from a prior cycle of the same chemotherapy

ScopeIncludes prior-cycle events considered when assessing need for prophylactic or therapeutic G‑CSF

Source guidanceUsed as a qualifying history in policy criteria for continued or prophylactic Stimufend use

Billing Codes, NDCs, and Dose Limits

Applicable CPT/HCPCS CodesHCPCS

Q5127

Injection, pegfilgrastim-fpgk, biosimilar, Stimufend 6 mg/0.6 mL solution prefilled syringe

Applicable NDCsNDC

65219-0371-10

Stimufend 0.6 mL solution prefilled syringe 6 mg

Applicable ICD-10 Diagnoses (listed)ICD-10

D70.1	Agranulocytosis secondary to cancer chemotherapy
D70.9	Neutropenia, unspecified
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs initial encounter
T4S.1XSD	Adverse effect of antineoplastic and immunosuppressive drugs subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs sequela
Z51.11	Encounter for antineoplastic chemotherapy
Z51.12	Encounter for antineoplastic immunotherapy
Z51.89	Encounter for other specified aftercare

inv-09: Dose limits — per-dose adult dose and frequency

Per-dose adult dose6 mg subcutaneously per dose

Frequency — acute radiation exposure6 mg subcutaneously weekly for 2 doses

Frequency — chemotherapy indications6 mg subcutaneously once per chemotherapy cycle and no more frequently than every 14 days

Pediatric noteWeight‑based dosing for patients <45 kg (see dosing guidance)

Authorization, Documentation, and Step Edits

Prior Authorization

Prior Authorization Required

Prior authorization required. Stimufend requires prior authorization. Commercial, Medicaid, and Medicare members are subject to step therapy; Neulasta and Udenyca are the preferred agents and must be used first unless contraindicated or previously failed.

Stimufend requires prior authorization for Commercial, Medicaid, and Medicare members.
Step therapy: member must have trial and failure of, or contraindication to, preferred agents Neulasta and Udenyca before Stimufend will be approved, except in cases meeting the medical-necessity exceptions in the Initial Approval Criteria (e.g., continuation of previously established Stimufend therapy; lack of home health services; expected G-CSF use ≥5 consecutive days; specific dose-dense chemotherapy regimens listed).
Providers should supply supporting journal citations when requesting Stimufend for chemotherapy regimens other than the listed dose-dense regimens, since pegylated filgrastim is the only G-CSF studied in published trials for those regimens.

Step Therapy

Preferred Agent / Step Therapy

Preferred agent and step therapy requirement. Neulasta and Udenyca are preferred for Commercial, Medicaid, and Medicare members; Stimufend will be considered only after these agents fail or are contraindicated, unless other listed criteria for Stimufend use are met.

Background and Indications

Stimufend (pegfilgrastim-fpgk) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The agent is used prophylactically to reduce the risk of febrile neutropenia and to support maintenance of dose-dense chemotherapy schedules when appropriate.

When administering Stimufend, do not give within 14 days before and 24 hours after cytotoxic chemotherapy. The standard adult per-dose amount is 6 mg subcutaneously once per chemotherapy cycle (see dosing exceptions for acute radiation exposure and pediatric weight-based dosing).

Clinical Definitions

inv-15: Febrile neutropenia — thresholds and explanation

Temperature numeric thresholdSingle temperature ≥38.3°C OR ≥38.0°C sustained over 1 hour

Neutropenia numeric thresholdANC <500 neutrophils/µL OR ANC <1,000 neutrophils/µL with predicted decline to <500 within 48 hours

Operational explanationBoth temperature and neutropenia criteria must be met to define febrile neutropenia for treatment and prophylaxis decisions

inv-16: Patient who experienced a neutropenic complication — prior-cycle definition

Definition (concise)A patient who experienced a neutropenic complication from a prior cycle of the same chemotherapy

Use in criteriaPrior-cycle neutropenic complications count toward eligibility for prophylactic or continuing Stimufend per policy criteria

Policy Update Log

2025-03-18criteria_revisionLatest

Updated patient risk factors (co-morbidities) for febrile neutropenia and added prophylactic-use criterion allowing use when expected FN risk is <10% with two or more patient-related risk factors; febrile neutropenia definition separated into a chart.

2024-03-21dosing_update

Updated dosing limits and dosing chart; added indication and dosing for patients acutely exposed to myelosuppressive radiation (6 mg weekly for 2 doses).

2023-09-15