CurrentCareSourcePolicy N/A

Colony Stimulating Factors — Pegfilgrastim Products Utilization Management

Defines prior authorization, coverage criteria, dosing limits, and excluded uses for pegfilgrastim and biosimilars for CareSource members receiving oncology care or other indicated uses (e.g., H-ARS, PBPC collection). Applies to medical benefit coverage of listed pegfilgrastim products.

Policy Summary

PayerCareSource

PolicyColony Stimulating Factors — Pegfilgrastim Products Utilization Management

Policy CodePolicy N/A

Change TypeRevised criteria and clarifications

Effective Date

Next Review DateOct 9, 2024

Key ActionSubmit prior authorization with documentation of indication, prescribing specialist or consultation, dosing, and supporting clinical rationale.

SourceLink

POLICY UPDATE CHANGES

The note providing examples of risk factors for febrile neutropenia was updated to clarify age criterion, define liver and renal dysfunction thresholds, and specify HIV patients with low CD4 counts.

Requirement for a neutropenic complication was updated to specify 'from prior chemotherapy cycle.'

The list of CSF examples was updated to add Ryzneuta and Rolvedon and remove Leukine.

6 mgstandard single dose limit for most indications

6 monthsauthorization period for chemotherapy-related indication

1 monthauthorization period for H-ARS indication

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Recommended Authorization Criteria

Cancer in a patient receiving myelosuppressive chemotherapy

Covered when ANY of the following FDA-approved chemotherapy-related conditions are met

Chemotherapy indications: Approve for 6 months if the patient meets EITHER (1) OR (2) OR (3)

1. High-risk regimen: Patient is receiving myelosuppressive anti-cancer medications associated with a high risk of febrile neutropenia (>=20% based on regimen)>=20%

Approve for 6 months

2. Intermediate-risk with risk factors: Patient is receiving myelosuppressive anti-cancer medications associated with less than 20% risk AND the prescriber identifies at least one risk factor for febrile neutropenia (examples: age >65 years receiving full chemotherapy intensity; recent chemotherapy or radiation; persistent neutropenia; bone marrow involvement by tumor; recent surgery/open wounds; liver dysfunction - bilirubin >= 2.0 mg/dL; renal dysfunction - creatinine clearance <= 50 mL/min; poor performance status; HIV with low CD4 count)

Approve for 6 months

3. Prior neutropenic complication: Patient had a neutropenic complication from a prior chemotherapy cycle and did not receive prophylaxis with a colony stimulating factor during that cycle; a reduced dose or frequency of chemotherapy would compromise treatment outcome; and the medication is prescribed by or in consultation with an oncologist or hematologist

Approve for 6 months

Radiation syndrome (H-ARS)

Covered when ALL of the following are met

H-ARS: Agent prescribed by or in consultation with a physician with expertise in treating acute radiation syndrome

Approve for 1 month; dosing: up to two doses of 6 mg subcutaneously no more frequently than 1 week apart

Peripheral blood progenitor cell (PBPC) collection and therapy

Covered when ALL of the following are met

PBPC collection: Prescribed by or in consultation with an oncologist, hematologist, or physician specializing in transplantation

Approve one dose up to 6 mg subcutaneously one time

Coverage of pegfilgrastim products is not recommended for treatment of myelodysplastic syndrome (MDS) and for any other circumstances that are not specifically listed in the Recommended Authorization Criteria. Requests for indications outside the criteria set may be denied and the criteria will be updated if new published data become available.

Use of pegfilgrastim for myelodysplastic syndrome (MDS) is not recommended due to limited published data and because the NCCN MDS guidelines (version 3.2024) do not list pegfilgrastim as a recommended therapy in this population.

Product Codes, Risk Thresholds, and Key Values

Authorization, Documentation, and Exceptions

Prior Authorization

Prior authorization required for medical benefit coverage

Prior Authorization is recommended for medical benefit coverage of pegfilgrastim products. Approvals are provided for the durations noted in the policy and require that the medication be prescribed by or in consultation with a physician who specializes in the condition being treated; extended approvals are allowed if the patient continues to meet the Criteria and Dosing. All approvals are provided for the duration noted in the policy (months defined as 30 days).

Approvals provided for durations specified in the policy (e.g., 6 months for chemotherapy indications, 1 month for H-ARS).
Medication must be prescribed by or in consultation with an appropriate specialist (oncologist, hematologist, or physician with expertise in the treated condition).

Step Therapy

Dose exceptions reviewed case-by-case

Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Clinical Background

Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) indicated to decrease the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy. It is also used for the hematopoietic syndrome of acute radiation syndrome (H-ARS) and for mobilization/collection of peripheral blood progenitor cells (PBPC). FDA-approved pegfilgrastim biosimilars are considered appropriate substitutes per guideline recommendations.

Terms and Product Definitions

Pegfilgrastim products

Included productsNeulasta; biosimilars Fulphila, Fylnetra, Stimufend, Nyvepria, Udenyca, Ziextenzo

H-ARS labeling noteOnly Neulasta, Stimufend, Udenyca, and Ziextenzo labeling carries the H-ARS indication

Substitution guidanceFDA‑approved biosimilars are considered appropriate substitutes per guideline references

High risk of febrile neutropenia

DefinitionChemotherapy regimens associated with at least a 20% risk of febrile neutropenia

Source for useRegimens meeting this threshold qualify for prophylactic pegfilgrastim (approve for 6 months)