CurrentAgency for Health Care AdministrationPolicy N/A

Colony-Stimulating Factors

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This policy governs prior authorization and coverage criteria for preferred and non-preferred colony-stimulating factor medications for cancer-related indications, severe chronic neutropenia, AIDS-related neutropenia, and chemotherapy- or radiation-induced neutropenia.

Policy Summary

PayerAgency for Health Care Administration

PolicyColony-Stimulating Factors

Policy CodePolicy N/A

Change TypeRoutine revisionno material clinical or coverage changes

Effective DateJanuary 21, 2026

Next Review DateN/A

Key ActionSubmit documentation of inadequate response or intolerance to at least one preferred medication when requesting a non-preferred medication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Preferred products

12Non-preferred products requiring prior authorization

12 monthsMost covered indications

6 monthsAIDS-related authorization

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CurrentAgency for Health Care AdministrationPolicy N/A

Colony-Stimulating Factors

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Policy Summary

PayerAgency for Health Care Administration

PolicyColony-Stimulating Factors

Policy CodePolicy N/A

Change TypeRoutine revisionno material clinical or coverage changes

Effective DateJanuary 21, 2026

Next Review DateN/A

Key ActionSubmit documentation of inadequate response or intolerance to at least one preferred medication when requesting a non-preferred medication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3Preferred products

12Non-preferred products requiring prior authorization

12 monthsMost covered indications

6 monthsAIDS-related authorization

AIDS-related initial ANC threshold

Coverage Criteria

General review criteria

Covered when all of the following are met:

General medication requirements

The requested medication has an FDA-approved indication, and the patient is within the FDA-approved age limits.
The patient has tried at least one preferred medication with the FDA-approved indication and experienced inadequate response or intolerance.
Documentation required.

Cancer patients

Covered for cancer-related indications when the general review criteria are met:

Cancer indications

The patient has not yet undergone chemotherapy, but chemotherapy has been prescribed.
The patient is receiving myelosuppressive chemotherapy.
The patient is receiving a bone marrow transplant.
The patient is receiving induction or consolidation chemotherapy for acute myeloid leukemia (AML).
The patient is undergoing peripheral blood progenitor cell collection and therapy.

Severe chronic neutropenia

Covered when all of the following are met:

The patient has congenital, cyclic, or idiopathic severe chronic neutropenia.
Official laboratory documentation establishes an ANC at or below the required threshold.ANC ≤ 1,500 cells/µL
Official laboratory documentation required.

Acquired Immunodeficiency Syndrome

Covered when all of the following are met:

AIDS-related severe neutropenia

The patient has severe neutropenia associated with AIDS and is receiving antiretroviral therapy.
Applicable treatment-phase threshold
- The patient is receiving initial therapy and official laboratory documentation establishes an ANC at or below the applicable threshold.ANC ≤ 1,000 cells/µL
- The patient is receiving continuation therapy and official laboratory documentation establishes an ANC at or below the applicable threshold.ANC ≤ 1,600 cells/µL

Chemotherapy or radiation induced neutropenia

Covered when either of the following is met:

Chemotherapy- or radiation-induced neutropenia

The patient has a non-myeloid malignancy and is receiving myelosuppressive chemotherapy.
The patient was acutely exposed to myelosuppressive doses of radiation consistent with Hematopoietic Syndrome of Acute Radiation Syndrome.

Continuation therapy

Covered when all of the following are met:

Continuation requirements

The patient met the initial review criteria.
Documentation shows a positive clinical response.
The patient has not experienced any treatment-restricting adverse effects.
Dosing is appropriate according to product labeling or is supported by compendia.

Clinical Thresholds

Severe chronic neutropenia

ConditionCongenital, cyclic, or idiopathic severe chronic neutropenia

ANC threshold≤ 1,500 cells/µL

DocumentationOfficial laboratory documentation is required

AIDS-related severe neutropenia — initial therapy

ConditionSevere neutropenia in patients with AIDS receiving antiretroviral therapy

ANC threshold≤ 1,000 cells/µL for initial therapy

DocumentationOfficial laboratory documentation is required

Authorization and Documentation Requirements

Prior Authorization

Clinical Prior Authorization Required

Non-preferred colony-stimulating factor products require clinical prior authorization. The requested medication must have an FDA-approved indication, and the patient must be within the FDA-approved age limits.

Non-preferred products include Fulphila, Fylnetra, Granix, Neulasta, Nivestym, Releuko, Rolvedon, Ryzneuta, Stimufend, Udenyca, Zarxio, and Ziextenzo.
Preferred products are Leukine, Neupogen, and Nyvepria.

Step Therapy

Preferred-Product Step Therapy

Before approval of a non-preferred medication, the patient must have tried at least one preferred medication for the FDA-approved indication.

Preferred products: Leukine, Neupogen, and Nyvepria.

Policy Background

Colony-stimulating factors support neutrophil production and are used to reduce or treat severe neutropenia. This policy establishes coverage and prior authorization requirements for preferred and non-preferred products when used for cancer-related indications, severe chronic neutropenia, AIDS-related neutropenia, or neutropenia associated with chemotherapy or acute exposure to myelosuppressive radiation. Coverage is subject to the applicable FDA-approved indication, age requirements, and clinical criteria.

Key Definitions

Absolute neutrophil count (ANC)

TermANC

DefinitionAbsolute neutrophil count

Unit of measureCells per microliter (cells/µL)

Policy useUsed to establish laboratory eligibility for severe chronic neutropenia and AIDS-related severe neutropenia

Hematopoietic Syndrome of Acute Radiation Syndrome

TermHematopoietic Syndrome of Acute Radiation Syndrome

DefinitionA syndrome resulting from acute exposure to myelosuppressive doses of radiation

Initial Therapy

Initial therapy

Initial approval requires all of the following:

Initial approval requirements

The requested medication has the FDA-approved indication, and the patient is within the FDA-approved age limits.
The patient has tried at least one preferred medication with the FDA-approved indication and experienced inadequate response or intolerance.
Documentation required.

Continuation Therapy

Continuation therapy

Continuation therapy requires all of the following:

Continuation requirements

The patient met the initial review criteria.
Documentation shows a positive clinical response.
The patient has not experienced any treatment-restricting adverse effects.
Dosing is appropriate according to product labeling or is supported by compendia.

Preferred Product Requirement

Step	Requirement	Documentation
1	Trial of at least one preferred medication with the FDA-approved indication before approval of a non-preferred medication	Document inadequate response or intolerance to the preferred medication

Policy Summary

PayerAgency for Health Care Administration

PolicyColony-Stimulating Factors

Policy CodePolicy N/A

Change TypeRoutine revisionno material clinical or coverage changes

Effective DateJanuary 21, 2026

Next Review DateN/A

Key ActionSubmit documentation of inadequate response or intolerance to at least one preferred medication when requesting a non-preferred medication.

SourceLink

On This Page

AIDS-related severe neutropenia — continuation therapy

ConditionSevere neutropenia in patients with AIDS receiving antiretroviral therapy

ANC threshold≤ 1,600 cells/µL for continuation therapy

DocumentationOfficial laboratory documentation is required

Documentation Required

Document Preferred-Medication Trial Outcome

Document that the preferred medication trial resulted in an inadequate response or intolerance.

Documentation must support the inadequate response or treatment intolerance.

Documentation Required

Severe Chronic Neutropenia Laboratory Results

For severe chronic neutropenia, submit official laboratory documentation of the absolute neutrophil count (ANC).

The patient must have congenital, cyclic, or idiopathic severe chronic neutropenia.
ANC must be ≤ 1,500 cells/µL.
Length of authorization: up to 12 months.

Documentation Required

AIDS-Related Neutropenia Laboratory Results

For AIDS-related neutropenia, submit official ANC laboratory documentation for initial or continuation therapy.

The patient must have severe neutropenia while receiving antiretroviral therapy.
Initial therapy: ANC must be ≤ 1,000 cells/µL.
Continuation therapy: ANC must be ≤ 1,600 cells/µL.
Length of authorization: 6 months.

Denial Risk

FDA Indication or Age Requirement Not Met

Coverage may be denied when the requested medication does not have the applicable FDA-approved indication or when the patient is outside the FDA-approved age limits.

The FDA-approved indication and age requirements must both be met.

Denial Risk

Preferred-Product Step Requirement Not Met

Coverage of a non-preferred medication may be denied when the patient has not tried at least one preferred medication for the FDA-approved indication.

The preferred-medication trial requirement applies before non-preferred approval.
The trial must demonstrate inadequate response or intolerance, supported by documentation.

Denial Risk

Required Neutrophil Laboratory Documentation Absent

Coverage may be denied when required official ANC laboratory documentation is absent or does not establish the applicable threshold.

Severe chronic neutropenia: ANC ≤ 1,500 cells/µL.
AIDS-related neutropenia initial therapy: ANC ≤ 1,000 cells/µL.
AIDS-related neutropenia continuation therapy: ANC ≤ 1,600 cells/µL.

Documentation Required

Continuation Therapy Documentation

For continuation therapy, document that the patient met the initial review criteria, has a positive clinical response, has no treatment-restricting adverse effects, and is receiving appropriate dosing.

Dosing must follow labeling or be supported by compendia.

Denial Risk

Continuation Criteria Not Met

Continuation coverage may be denied when initial eligibility, positive clinical response, adverse-effect status, or appropriate dosing is not established.

The patient must have met the initial review criteria.
Documentation of positive clinical response is required.
The patient must not have experienced treatment-restricting adverse effects.
Dosing must be appropriate according to labeling or supported by compendia.

Policy indicationApplies to patients acutely exposed to myelosuppressive doses of radiation