CurrentWashington State Health Care AuthorityPolicy 82.40.15-2

Granulocyte Colony Stimulating Factors (G-CSF)

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This policy governs prior authorization and medical-necessity coverage for filgrastim, pegfilgrastim, eflapegrastim-xnst, tbo-filgrastim, and their biosimilars for Apple Health members. It establishes preferred-drug sequencing, covered indications, clinical approval criteria, exclusions, dosage and quantity limits, and applicable HCPCS billing codes.

Policy Summary

PayerWashington State Health Care Authority

PolicyGranulocyte Colony Stimulating Factors (G-CSF)

Policy CodePolicy 82.40.15-2

Change TypeClarified and added

Effective DateOct 1, 2025

Next Review DateNot scheduled

Key ActionFor pegfilgrastim or eflapegrastim-xnst, document treatment failure or a clearly stated rationale for inability to complete treatment with one preferred short-acting G-CSF agent.

SourceLink

POLICY UPDATE CHANGES

The policy clarified that pegfilgrastim and eflapegrastim-xnst generally require documented treatment failure or a clearly stated inability to complete treatment with one preferred short-acting G-CSF agent.

The policy added Rolvedon, Releuko, Nyvepria, Stimufend, and Fylnetra and added or updated their associated HCPCS codes.

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CurrentWashington State Health Care AuthorityPolicy 82.40.15-2

Granulocyte Colony Stimulating Factors (G-CSF)

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Sign up for Washington State Health Care Authority Policy 82.40.15-2 alerts

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Policy Summary

PayerWashington State Health Care Authority

PolicyGranulocyte Colony Stimulating Factors (G-CSF)

Policy CodePolicy 82.40.15-2

Change TypeClarified and added

Effective DateOct 1, 2025

Next Review DateNot scheduled

Key ActionFor pegfilgrastim or eflapegrastim-xnst, document treatment failure or a clearly stated rationale for inability to complete treatment with one preferred short-acting G-CSF agent.

SourceLink

POLICY UPDATE CHANGES

The policy added Rolvedon, Releuko, Nyvepria, Stimufend, and Fylnetra and added or updated their associated HCPCS codes.

3 monthsApproval duration for most chemotherapy-related prevention and AML criteria

12 monthsApproval duration for severe chronic neutropenia

1/cyclePegfilgrastim quantity limit during cancer chemotherapy

>20%Chemotherapy risk threshold for primary prophylaxis

3-10 GyRadiation exposure range addressed

13 codesG-CSF products listed

Covered Indications and Exclusions

AML induction or consolidation

Covered when all criteria are met.

AML induction or consolidation: The patient is receiving induction and/or consolidation chemotherapy for acute myeloid leukemia (AML).

Approval may be granted for 3 months.

Primary prevention of febrile neutropenia

Filgrastim is covered when at least one primary-prevention criterion is met. Pegfilgrastim and eflapegrastim-xnst additionally require the long-acting-agent criterion.

At least one qualifying criterion
- High-risk chemotherapy regimen: The chemotherapy regimen has a greater than 20% risk for febrile neutropenia.>20%
- Intermediate-risk regimen with risk factor: The chemotherapy regimen has a 10–20% risk for febrile neutropenia and the member has at least one of the following: extensive prior chemotherapy or radiation therapy to the pelvis or other areas important for bone marrow reserve; persistent neutropenia; bone marrow involvement by tumor; recent surgery or open wounds; liver dysfunction; renal dysfunction; age greater than 65 years while receiving full chemotherapy dose intensity; or poor performance status.10–20% regimen risk plus at least 1 risk factor
- Prior dose-limiting neutropenic event: The member experienced a treatment delay of curative chemotherapy due to a dose-limiting neutropenic event, with the same dose and schedule planned for future cycles.
Long-acting-agent requirement: For pegfilgrastim or eflapegrastim-xnst, documented treatment failure or a clearly stated rationale for inability to complete a course of treatment with one preferred short-acting G-CSF agent is required.One preferred short-acting G-CSF agent
Examples include inability to administer daily injections or the member being a young child.

Secondary prevention of febrile neutropenia

Filgrastim is covered when at least one qualifying prior event occurred. Pegfilgrastim and eflapegrastim-xnst additionally require the long-acting-agent criterion.

At least one qualifying prior event
- The member experienced febrile neutropenia during a previous cycle of similar chemotherapy, with the same dose and schedule planned for future cycles.
- The member experienced a treatment delay of curative chemotherapy due to a dose-limiting neutropenic event, with the same dose and schedule planned for future cycles.
- The member experienced a treatment delay of palliative chemotherapy due to a dose-limiting neutropenic event, and dose reduction or a delay in frequency of subsequent chemotherapy cycles is not recommended.
Long-acting-agent requirement: For pegfilgrastim or eflapegrastim-xnst, documented treatment failure or a clearly stated rationale for inability to complete a course of treatment with one preferred short-acting G-CSF agent is required.

Treatment of febrile neutropenia

Both criteria must be met.

The patient has been diagnosed with febrile neutropenia.
The patient has at least one high-risk factor: age greater than 65 years; hospitalization for febrile neutropenia; sepsis syndrome; invasive fungal infection; clinically documented infection such as pneumonia; prolonged or profound neutropenia; or a history of prior episodes of febrile neutropenia.At least 1 high-risk factor

Cancer patients undergoing bone marrow transplantation

Both criteria must be met.

Filgrastim is administered at least 24 hours after cytotoxic chemotherapy or bone marrow infusion.At least 24 hours after chemotherapy or infusion
CBC and platelet counts are monitored daily during neutrophil recovery.Daily monitoring

Autologous progenitor-cell collection

Both criteria must be met.

Autologous peripheral blood progenitor-cell collection

Filgrastim is administered for at least 4 days before the first leukapheresis procedure.At least 4 days before first leukapheresis
Filgrastim is continued until the last leukapheresis.Through the last leukapheresis

Severe chronic neutropenia

The diagnosis must be confirmed before treatment is approved.

Severe chronic neutropenia: The diagnosis of severe chronic neutropenia is confirmed by serial CBCs with differential and platelet counts, bone marrow morphology, and karyotype evaluation.Diagnostic confirmation required

Approval may be granted for 12 months.

Acute exposure to myelosuppressive radiation

Covered for the specified exposure scenario.

Hematopoietic subsyndrome of acute radiation syndrome: The patient has hematopoietic subsyndrome of acute radiation syndrome after accidental or intentional exposure to lethal doses of total-body radiation that are not high enough to cause certain death from injury to other organs.3–10 Gy total-body radiation

Filgrastim or pegfilgrastim may be approved.

Filgrastim is not medically necessary for splenic rupture, acute respiratory distress syndrome, serious allergic reaction to pegfilgrastim, sickle cell crisis, capillary leak syndrome, aortitis, or cutaneous vasculitis. Coverage is also excluded when the WBC count is greater than 100 × 10⁹/L (100,000 K/mL) or the ANC is greater than 10 × 10⁹/L (10,000 K/mL), when administered within 24 hours before or after chemotherapy, for routine prophylaxis with low-risk febrile-neutropenia chemotherapy regimens, or for routine prophylaxis with chemoradiation.

Pegfilgrastim is not medically necessary for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Additional exclusions include splenic rupture, acute respiratory distress syndrome, serious allergic reaction to filgrastim, sickle cell crisis, capillary leak syndrome, aortitis, cutaneous vasculitis, WBC count greater than 100 × 10⁹/L (100,000 K/mL) or ANC greater than 10 × 10⁹/L (10,000 K/mL), administration within 24 hours after chemotherapy, cytotoxic chemotherapy given more often than every 14 days, routine prophylaxis with low-risk febrile-neutropenia chemotherapy regimens, or routine prophylaxis with chemoradiation.

HCPCS Codes and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J1442	NEUPOGEN — Injection, filgrastim (G-CSF), excludes biosimilars, 1 microgram.
J1447	GRANIX — Injection, tbo-filgrastim, 1 microgram.
J1449	ROLVEDON — Injection, eflapegrastim-xnst, 0.1 mg.
J2506	NEULASTA — Injection, pegfilgrastim, 6 mg.
Q5101	ZARXIO — Injection, filgrastim (G-CSF), biosimilar, 1 microgram.
Q5108	FULPHILA — Injection, pegfilgrastim-jmdb, biosimilar (Fulphila), 0.5 mg.
Q5110	NIVESTYM — Injection, filgrastim-aafi, biosimilar (Nivestym), 1 microgram.
Q5111	UDENYCA — Injection, pegfilgrastim-cbqv (Udenyca), biosimilar, 0.5 mg.
Q5120	ZIEXTENZO — Injection, pegfilgrastim-bemz, biosimilar (Ziextenzo), 0.5 mg.
Q5122	NYVEPRIA — Injection, pegfilgrastim-apgf (Nyvepria), biosimilar, 0.5 mg.

1–10 of 13

1/2

Chemotherapy regimen riskGreater than 20% risk for febrile neutropenia

Chemotherapy regimen risk10–20% risk for febrile neutropenia, with at least one additional risk factor

Persistent neutropeniaANC ≤ 1,000/mm³

Liver dysfunctionBilirubin > 2.0 mg/dL

Renal dysfunctioneGFR < 50 mL/min/1.73 m²

Authorization and Documentation Requirements

Prior Authorization

Class Prior Authorization Required

Prior authorization is required for non-preferred G-CSF agents and new-to-market drugs added to this class through the Apple Health Preferred Drug List. If a drug receives a new FDA-approved indication, medical necessity for that indication is determined case by case according to FDA labeling.

Non-preferred agents and new-to-market agents are subject to these PA criteria.

Documentation Required

Indication-Specific Approval

Requests must document that the member meets the clinical criteria for the specific requested indication. Approval duration depends on the indication and may range from 1 month to 12 months.

Covered indications include AML induction or consolidation, primary or secondary prevention of febrile neutropenia, treatment of febrile neutropenia, BMT, peripheral blood progenitor-cell collection, severe chronic neutropenia, and acute radiation syndrome.

Policy Background

Granulocyte colony-stimulating factors (G-CSFs) are glycoprotein cytokines that stimulate granulocyte production from hematopoietic stem cells. They are used to prevent or treat infection-related complications of neutropenia, particularly in patients receiving myelosuppressive chemotherapy, and may also be used in settings such as bone marrow transplantation, autologous progenitor-cell collection, severe chronic neutropenia, and hematopoietic subsyndrome of acute radiation syndrome.

Filgrastim is a short-acting G-CSF, while pegfilgrastim is modified to have a longer half-life and generally requires fewer administrations. Coverage under this policy applies to these and other G-CSF products when the applicable clinical criteria and authorization requirements are met.

Key Clinical Definitions

Granulocyte colony-stimulating factor (G-CSF)

TypeGlycoprotein cytokine

Alternate nameColony-stimulating factor 3

Biological functionStimulates formation of granulocyte colonies from the proliferation of a single hematopoietic stem cell

Hematopoietic subsyndrome of acute radiation syndrome

SyndromeHematopoietic subsyndrome of acute radiation syndrome

CauseLethal total-body radiation exposure

Exposure limitationRadiation is not high enough to cause certain death from injury to other organs; the policy addresses 3–10 Gy

Initial Therapy

Indication-specific initial therapy

Initial therapy is covered when the criteria for the selected indication are met.

Covered indication

The request is for AML induction or consolidation, and the AML criteria are satisfied.
The request is for primary prevention of febrile neutropenia, and the primary-prevention criteria are satisfied.
The request is for secondary prevention of febrile neutropenia, and the secondary-prevention criteria are satisfied.
The request is for treatment of febrile neutropenia, and the treatment criteria are satisfied.

Continuation Therapy

Secondary prevention continuation

Continuation for secondary prevention is covered when the prior neutropenic-event criteria are met. For pegfilgrastim or eflapegrastim-xnst, the long-acting-agent requirement also applies.

At least one qualifying prior event
- Febrile neutropenia occurred during a previous cycle of similar chemotherapy, with the same dose and schedule planned for future cycles.
- Curative chemotherapy was delayed because of a dose-limiting neutropenic event, with the same dose and schedule planned for future cycles.
- Palliative chemotherapy was delayed because of a dose-limiting neutropenic event, and dose reduction or a delay in frequency of subsequent chemotherapy cycles is not recommended.
Long-acting-agent requirement:

Preferred-Agent Sequencing

Step	Applies to	Requirement	Documentation
1	Non-preferred or new-to-market agents in the class	Try at least two preferred agents before requesting the non-preferred agent.	Document inadequate response or intolerance due to a severe adverse reaction or contraindication to both preferred agents.
1	When only one preferred agent exists	Try the one preferred agent before requesting the non-preferred agent.	Document inadequate response or intolerance due to a severe adverse reaction or contraindication to the available preferred agent.

Step	Agents	Required prerequisite	Exception and documentation
1	Pegfilgrastim or eflapegrastim-xnst	Use or attempt one preferred short-acting G-CSF agent first and document treatment failure.	If the member cannot complete the course, document a clear rationale, such as inability to administer daily injections or the member being a young child.

Dosage and Quantity Limits

Filgrastim

Starting dose5 µg/kg/day

AdministrationSubcutaneous injection or intravenous infusion, rounded to the nearest dosage size

Monthly limitUp to 14 doses per month

Pegfilgrastim

Cycle limit1 dose per chemotherapy cycle

Dose for patients over 45 kg6 mg

Pediatric dose for 31–44 kg4 mg

Biosimilar Products

Billing Rule

Apply class rules to Nivestym

Nivestym is a filgrastim biosimilar and is subject to the class preferred-drug and prior-authorization rules. Apply the applicable preferred-drug sequencing requirements when requesting or billing this product.

Product: filgrastim-aafi (Nivestym).
HCPCS: Q5110.

Billing Rule

Apply class rules to Releuko

Releuko is a filgrastim biosimilar and is subject to the class preferred-drug and prior-authorization rules. Apply the applicable preferred-drug sequencing requirements when requesting or billing this product.

Product: filgrastim-ayow (Releuko).
HCPCS: Q5125.

Policy Summary

PayerWashington State Health Care Authority

PolicyGranulocyte Colony Stimulating Factors (G-CSF)

Policy CodePolicy 82.40.15-2

Change TypeClarified and added

Effective DateOct 1, 2025

Next Review DateNot scheduled

Key ActionFor pegfilgrastim or eflapegrastim-xnst, document treatment failure or a clearly stated rationale for inability to complete treatment with one preferred short-acting G-CSF agent.

SourceLink

On This Page

One preferred short-acting G-CSF agent

Age risk factorAge > 65 years while receiving full chemotherapy dose intensity

Laboratory exclusion thresholdWBC > 100 × 10⁹/L (100,000 K/mL) or ANC > 10 × 10⁹/L (10,000 K/mL)

Acute radiation exposureTotal-body radiation dose of 3–10 Gy

Step Therapy

Preferred-Agent Step Therapy

Preferred-agent step therapy applies before coverage of non-preferred agents. The request must establish inadequate response, documented intolerance due to a severe adverse reaction, or a contraindication to the required preferred therapy.

Document failure, severe adverse reaction, or contraindication to at least two preferred agents when two or more preferred agents are available.
If only one preferred agent is available in the class, document inadequate response to that one agent.

Step Therapy

Short-Acting G-CSF Step Required

Pegfilgrastim and eflapegrastim-xnst require a prior step with a preferred short-acting G-CSF for primary or secondary febrile-neutropenia prevention. The short-acting prerequisite must be satisfied before a long-acting agent can be approved.

The prerequisite applies to both primary and secondary prevention requests for pegfilgrastim or eflapegrastim-xnst.

Documentation Required

Document Preferred-Agent Trial History

Document the member's required prior preferred-agent trials or a qualifying exception. The record must identify the preferred agent(s) tried and show inadequate response, severe adverse reaction, or contraindication; for long-acting agents, document failure or inability to complete a preferred short-acting course.

A stated inability to complete daily injections may qualify when clinically supported, such as inability to self-administer or young age.

Documentation Required

Chemotherapy Prophylaxis Documentation

For primary chemotherapy prophylaxis, document the chemotherapy regimen's febrile-neutropenia risk and any applicable patient risk factors or prior neutropenic events.

Regimen risk greater than 20% qualifies.
For a 10–20% regimen risk, document at least one risk factor: extensive prior chemotherapy or pelvic/other marrow-reserve radiation; persistent ANC ≤1,000/mm³; marrow tumor involvement; recent surgery or open wounds; bilirubin >2.0 mg/dL; eGFR <50 mL/min/1.73 m²; age >65 receiving full dose intensity; or poor performance status.
A prior dose-limiting neutropenic event that delayed curative chemotherapy may qualify when the same dose and schedule are planned.

Documentation Required

Long-Acting Agent Documentation

Requests for pegfilgrastim or eflapegrastim-xnst for primary or secondary febrile-neutropenia prevention must include documentation of treatment failure with, or a clearly stated rationale for inability to complete, one preferred short-acting G-CSF agent.

Examples include inability to administer daily injections or a young child unable to complete daily therapy.
The long-acting agent requirement is in addition to the applicable primary- or secondary-prevention criteria.

Documentation Required

Febrile-Neutropenia Treatment Documentation

For treatment of febrile neutropenia, document the diagnosis and at least one high-risk factor.

High-risk factors include age >65; hospitalization for febrile neutropenia; sepsis syndrome; invasive fungal infection; a clinically documented infection such as pneumonia; prolonged or profound neutropenia; or prior febrile-neutropenia episodes.
Approval, when criteria are met, is for 1 month.

Documentation Required

Severe Chronic Neutropenia Documentation

For severe chronic neutropenia, submit evidence confirming the diagnosis before requesting filgrastim.

Provide serial CBCs with differential and platelet counts.
Provide bone marrow morphology and karyotype evaluation.
Filgrastim may be approved for 12 months after the diagnosis is confirmed.

Documentation Required

Bone Marrow Transplantation Documentation

For patients undergoing bone marrow transplantation, document the timing of filgrastim administration and monitoring during neutrophil recovery.

Administer filgrastim at least 24 hours after cytotoxic chemotherapy or bone marrow infusion.
Monitor CBC and platelet counts daily during neutrophil recovery.
Approval, when criteria are met, is for 3 months.

Documentation Required

Leukapheresis Documentation

For autologous peripheral blood progenitor-cell collection, document filgrastim administration through the leukapheresis course.

Administer filgrastim for at least 4 days before the first leukapheresis procedure.
Continue filgrastim until the last leukapheresis.
Approval, when criteria are met, is for 3 months.

Denial Risk

Explicit Non-Covered Uses

Requests may be denied when the requested use falls within an explicit non-covered condition or does not meet the policy's medical-necessity criteria.

Examples include splenic rupture, acute respiratory distress syndrome, serious allergic reaction to the alternate G-CSF, sickle cell crisis, WBC >100 × 10⁹/L or ANC >10 × 10⁹/L, capillary leak syndrome, aortitis, and cutaneous vasculitis.
Do not administer filgrastim within 24 hours before or after chemotherapy.
Routine prophylaxis is not covered for low-risk febrile-neutropenia regimens or with chemoradiation.

Denial Risk

Pegfilgrastim Exclusion

Pegfilgrastim is not medically necessary for mobilization of peripheral blood progenitor cells for hematopoietic stem-cell transplantation.

Use filgrastim when the policy criteria for autologous peripheral blood progenitor-cell collection are met.

Step Therapy

Preferred-Drug Sequencing

Sequence therapy according to the current Apple Health Preferred Drug List (AHPDL). Non-preferred agents require the applicable preferred-agent trial or exception documentation before PA approval.

Check the current AHPDL at https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx.
Preferred status may change; use the current list when submitting the request.

Denial Risk

Long-Acting G-CSF Prerequisite

A request for pegfilgrastim or eflapegrastim-xnst may be denied when documentation does not show treatment failure with, or a clearly stated inability to complete, one preferred short-acting G-CSF agent.

This prerequisite applies to both primary and secondary febrile-neutropenia prevention.
Document the reason daily short-acting treatment cannot be completed, such as inability to administer daily injections or a young child.

Severe chronic neutropenia (SCN)

ConditionSevere chronic neutropenia

Laboratory confirmationSerial CBCs with differential and platelet counts

Additional confirmationBone marrow morphology and karyotype evaluation

The request is for a patient with cancer undergoing bone marrow transplantation, and the transplantation criteria are satisfied.

The request is for autologous progenitor-cell collection, and the collection criteria are satisfied.

The request is for severe chronic neutropenia, and the diagnosis-confirmation criteria are satisfied.

The request is for hematopoietic subsyndrome of acute radiation syndrome, and the acute-radiation criteria are satisfied.

For pegfilgrastim or eflapegrastim-xnst, documented treatment failure or a clearly stated rationale for inability to complete a course of treatment with one preferred short-acting G-CSF agent is required.

One preferred short-acting G-CSF agent

Autologous collection continuation

Continuation through the collection procedure is required.

Autologous progenitor-cell collection continuation

Filgrastim was started at least 4 days before the first leukapheresis procedure.At least 4 days before first leukapheresis
Filgrastim is continued through the last leukapheresis.Through the last leukapheresis

Filgrastim for bone marrow transplantation

Initial dose10 µg/kg/day by intravenous infusion

Dose reductionReduce to 5 µg/kg/day when ANC is greater than 1 x 10^9/L for 3 consecutive days

ANC-based adjustmentResume 5 µg/kg/day if ANC falls below 1 x 10^9/L; increase to 10 µg/kg/day if ANC falls below 1 x 10^9/L during the 5 µg/kg/day period

Filgrastim for autologous progenitor-cell collection

Daily dose10 µg/kg/day

RouteSubcutaneous injection

IndicationAutologous peripheral blood progenitor-cell collection

Filgrastim for severe chronic neutropenia

Congenital neutropenia6 µg/kg by subcutaneous injection twice daily

Cyclic neutropenia5 µg/kg by subcutaneous injection once daily

Idiopathic neutropenia5 µg/kg by subcutaneous injection once daily

Filgrastim for acute radiation syndrome

Daily dose10 µg/kg/day

RouteSubcutaneous injection

IndicationHematopoietic subsyndrome of acute radiation syndrome

Pegfilgrastim for acute radiation syndrome

Maximum quantityUp to 2 doses per radiation exposure

Dose for patients over 45 kg6 mg per dose

Weight-based pediatric doses4 mg per dose for 31–44 kg; 2.5 mg per dose for 21–30 kg

Billing Rule

Apply class rules to Zarxio

Zarxio is a filgrastim biosimilar and is subject to the class preferred-drug and prior-authorization rules. Apply the applicable preferred-drug sequencing requirements when requesting or billing this product.

Product: filgrastim-sndz (Zarxio).
HCPCS: Q5101.

Billing Rule

Document the prerequisite for Nyvepria

Nyvepria is a pegfilgrastim biosimilar. Long-acting-agent requests require documented failure of one preferred short-acting G-CSF agent or a clearly stated inability to complete treatment with that agent.

Product: pegfilgrastim-apgf (Nyvepria).
HCPCS: Q5122.

Billing Rule

Document the prerequisite for Ziextenzo

Ziextenzo is a pegfilgrastim biosimilar. Long-acting-agent requests require documented failure of one preferred short-acting G-CSF agent or a clearly stated inability to complete treatment with that agent.

Product: pegfilgrastim-bmez (Ziextenzo).
HCPCS: Q5120.

Billing Rule

Document the prerequisite for Udenyca

Udenyca is a pegfilgrastim biosimilar. Long-acting-agent requests require documented failure of one preferred short-acting G-CSF agent or a clearly stated inability to complete treatment with that agent.

Product: pegfilgrastim-cbqv (Udenyca).
HCPCS: Q5111.

Billing Rule

Document the prerequisite for Stimufend

Stimufend is a pegfilgrastim biosimilar. Long-acting-agent requests require documented failure of one preferred short-acting G-CSF agent or a clearly stated inability to complete treatment with that agent.

Product: pegfilgrastim-fpgk (Stimufend).
HCPCS: Q5127.

Billing Rule

Document the prerequisite for Fulphila

Fulphila is a pegfilgrastim biosimilar. Long-acting-agent requests require documented failure of one preferred short-acting G-CSF agent or a clearly stated inability to complete treatment with that agent.

Product: pegfilgrastim-jmdb (Fulphila).
HCPCS: Q5108.