CurrentCareSourcePolicy N/A

Colony Stimulating Factors — Pegfilgrastim Products Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing limits, and exclusions for pegfilgrastim and its biosimilars for members receiving treatment through the medical benefit.

Policy Summary

PayerCareSource

PolicyColony Stimulating Factors — Pegfilgrastim Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAnnual revision with material clinical clarifications

Effective Date

Next Review DateOct 9, 2024

Key ActionObtain prior authorization and document prescriber specialty when requesting medical benefit coverage for pegfilgrastim products.

SourceLink

POLICY UPDATE CHANGES

Examples of risk factors for febrile neutropenia were updated to specify age >65 years receiving full chemotherapy dose intensity and to add laboratory definitions for liver and renal dysfunction and clarify HIV patients with low CD4 counts.

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

Peripheral blood progenitor cell (PBPC) collection/therapy entry was updated (diagnosis wording and dosing guidance consolidated).

6 mgstandard single dose authorized for most indications

6 monthsauthorization duration for cancer patients

1 monthauthorization duration for H-ARS

Recommended Authorization Criteria

Initial therapy — cancer prophylaxis

Covered when ONE of the following FDA‑approved scenarios is met (policy structure presents multiple pathways):

Cancer patients receiving myelosuppressive chemotherapy

Pathway A (high-risk regimen): Patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk (>=20%) of febrile neutropenia based on the chemotherapy regimen.
Pathway B (intermediate-risk with risk factor): Patient is receiving a regimen with <20% baseline febrile neutropenia risk AND the patient has at least one risk factor for febrile neutropenia as identified by the prescriber (examples: age >65 years receiving full chemotherapy dose intensity; 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).
Pathway C (reduced chemo intensity compromise or prior neutropenic complication): Either (a) a reduced dose or frequency of chemotherapy may compromise treatment outcome AND the medication is prescribed by or in consultation with an oncologist or hematologist; OR (b) the patient had a neutropenic complication from a prior chemotherapy cycle and did not receive prophylaxis with a colony stimulating factor previously.

Radiation syndrome (H-ARS)

Covered when ALL of the following are met:

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

PBPC collection and therapy

Covered for PBPC mobilization/collection when prescribed by an appropriate specialist:

PBPC collection: Approve one dose (up to 6 mg) if prescribed by or in consultation with an oncologist, hematologist, or transplant specialist for peripheral blood progenitor cell (PBPC) collection and therapy.

Coverage of pegfilgrastim products is not recommended for treatment of myelodysplastic syndrome (MDS). The policy identifies MDS as a condition for which there are limited data supporting pegfilgrastim use and cites guideline absence for this indication, therefore requests for MDS are not recommended for approval. Additionally, coverage is not recommended for clinical scenarios that are not explicitly listed in the policy's Recommended Authorization Criteria.

Uses of pegfilgrastim outside the conditions enumerated in the Recommended Authorization Criteria are not recommended for approval. The policy states that these criteria will be updated as new published data become available, so non-listed uses should be expected to require updated evidence before consideration.

Billing and Dosing Codes

Covered HCPCS (medical benefit) — policy references medical benefit pegfilgrastim productsHCPCSCovered

J2506	Pegfilgrastim biosimilar
J2507	Pegfilgrastim (Neulasta)

Dose limit — dosing and exceptions

Standard single-dose limitUp to 6 mg by subcutaneous injection for most indications (standard single dose).

Cancer prophylaxis frequency restrictionNo more frequently than once every 2 weeks when used for cancer patients receiving myelosuppressive chemotherapy.

H-ARS dosing exceptionFor Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS): up to two doses of up to 6 mg given no more frequently than 1 week apart.

PBPC collection dosingFor peripheral blood progenitor cell (PBPC) collection/therapy: one dose up to 6 mg given one time.

Dose-exception reviewRequests for doses outside these limits will be considered case-by-case by a clinician (Medical Director or Pharmacist).

Authorization, Prescribing, and Review Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of pegfilgrastim products. Approvals are provided for the durations and dosing limits specified in the policy; extended approvals are allowed if the patient continues to meet the Criteria and Dosing. All approvals are provided for the duration noted in months (1 month = 30 days).

Approved duration examples: cancer prophylaxis — 6 months; H-ARS — 1 month.

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).

Risk Definitions and Clinical Thresholds

High risk of febrile neutropenia — regimen threshold

Definition of high-risk FN regimensChemotherapy regimens associated with a high risk of febrile neutropenia (defined as ≥20% risk based on the chemotherapy regimen).

Guideline basisNCCN and ASCO guidelines recommend prophylactic CSF use for regimens with ≥20% FN risk; consider CSF for intermediate risk (10–20%) when additional patient risk factors are present.

Use in approval pathwayPatients receiving myelosuppressive anti-cancer medications with ≥20% FN risk meet Pathway A for approval (authorize up to 6 months).

Liver dysfunction (risk factor) — operational threshold

Operational definition (example)Liver dysfunction defined in policy examples as total bilirubin ≥ 2.0 mg/dL.

Context of use

Clinical Background

Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) formulated to increase neutrophil production and reduce the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy. It is also indicated for the hematopoietic syndrome of acute radiation syndrome (H-ARS). Clinical guidelines (for example NCCN and ASCO) and FDA approvals support prophylactic use of pegfilgrastim in patients receiving regimens associated with a high risk of febrile neutropenia.