CurrentCareSourcePolicy N/A

Colony Stimulating Factors — Pegfilgrastim Products Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing, and exclusions for pegfilgrastim products (Neulasta and listed biosimilars) for CareSource members; applies to medical benefit use in oncology and related indications.

Policy Summary

PayerCareSource

PolicyColony Stimulating Factors — Pegfilgrastim Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeRevised clinical risk factor definitions

Effective Date

Next Review DateOct 9, 2024

Key ActionSubmit prior authorization with documentation of regimen febrile neutropenia risk and prescriber specialty; approvals granted when Criteria and Dosing are met.

SourceLink

POLICY UPDATE CHANGES

Updated examples of risk factors for febrile neutropenia including clarification of age criterion and definitions for liver and renal dysfunction.

Added Ryzneuta and Rolvedon to example list of colony stimulating factors and removed Leukine from that list.

Updated PBPC collection diagnosis wording and standardized single-dose adult dosing language.

6 mgstandard single dose (adult)

6 monthsapproval duration (chemo prophylaxis)

1 monthapproval duration (H-ARS)

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Coverage Criteria for Pegfilgrastim Products

Initial Therapy and Indications

Coverage of pegfilgrastim products is recommended when any one of the following indication-specific sets of conditions is met:

Overall allowed indications: Any one of the following indication groups (A: cancer with myelosuppressive chemotherapy, B: H-ARS, C: PBPC collection) qualifies

A. Cancer in a patient receiving myelosuppressive chemotherapy

i: Patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (>= 20% risk based on the chemotherapy regimen).>=20% regimen risk
ii
- a: Patient is receiving myelosuppressive anti-cancer medications associated with a risk of febrile neutropenia <20% based on the regimen.<20% regimen risk
- b: Patient has at least one risk factor for febrile neutropenia according to the prescriber. Examples include: 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 counts.
iii: Patient who had a neutropenic complication from a prior chemotherapy cycle and did not receive prophylaxis with a colony stimulating factor; approve when prescribed by or in consultation with an oncologist or hematologist and a reduced dose/frequency of chemotherapy would compromise outcome.

B. Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS): Approve for 1 month if the agent is prescribed by or in consultation with a physician with expertise in treating acute radiation syndrome.

C. Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy: Approve one dose if prescribed by or in consultation with an oncologist, hematologist, or transplantation specialist.

Use of pegfilgrastim products is not recommended for Myelodysplastic Syndrome (MDS) due to limited data supporting benefit in this population. The policy excludes MDS from recommended approvals and aligns with guideline statements that do not endorse routine pegfilgrastim use for MDS.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Specifically, MDS (Myelodysplastic Syndrome) is listed among conditions for which pegfilgrastim products are not recommended, and the policy indicates criteria will be updated if new published data become available.

Myelosuppressive Chemotherapy Regimens & Indications

Regimen/Guidance	When Prophylaxis Is Recommended
Myelosuppressive chemotherapy regimens associated with high risk of febrile neutropenia per NCCN/Hematopoietic Growth Factors guidance (risk >= 20%).	Prophylactic pegfilgrastim is recommended when the chemotherapy regimen confers a >=20% risk of febrile neutropenia.
Myelosuppressive chemotherapy regimens associated with intermediate or lower regimen risk (<20%) per NCCN/ASCO guidance with additional patient risk factors (examples: age >=65 years receiving full chemotherapy dose intensity; persistent neutropenia; bone marrow involvement by tumor; recent surgery/open wounds; liver dysfunction defined as bilirubin >=2.0 mg/dL; renal dysfunction defined as creatinine clearance <=50 mL/min; poor performance status; HIV with low CD4 counts).	Prophylactic pegfilgrastim is recommended when the regimen risk is <20% but the patient has at least one prescriber-identified risk factor for febrile neutropenia or when a reduced chemotherapy dose/frequency would compromise outcome (approve for 6 months when criteria met).
Patients who experienced a neutropenic complication from a prior chemotherapy cycle and did not receive prophylaxis with a colony stimulating factor (prescribed by or in consultation with an oncologist/hematologist).	Prophylactic pegfilgrastim is recommended to prevent recurrence when prior neutropenic complication occurred and chemotherapy dose reduction would compromise outcome (approve when prescribed by/with oncology/hematology).

Product Names, Dosing, and Codes

Covered product names (brand and biosimilars)mixedCovered

Neulasta	pegfilgrastim subcutaneous injection (Amgen) - product name listed
Fulphila	pegfilgrastim-jmdb subcutaneous injection (Mylan) - biosimilar
Fylnetra	pegfilgrastim-pbbk subcutaneous injection (Kashiv) - biosimilar
Stimufend	pegfilgrastim-fpgk subcutaneous injection (Fresenius Kabi) - biosimilar
Nyvepria	pegfilgrastim-apgf subcutaneous injection (Pfizer) - biosimilar
Udenyca	pegfilgrastim-cbqv subcutaneous injection (Coherus) - biosimilar
Ziextenzo	pegfilgrastim-bmez subcutaneous injection (Sandoz) - biosimilar

Dose frequency and amount — Pegfilgrastim (inv-05)

Standard adult doseUp to 6 mg by subcutaneous injection (standard single dose)

Therapeutic dosing frequency limitNo more frequently than once every 2 weeks for therapeutic/chemotherapy prophylaxis

PBPC collection dosingApprove one dose of up to 6 mg by subcutaneous injection (single dose)

H-ARS dosing frequencyFor H-ARS, approve two doses of up to 6 mg by subcutaneous injection given no more frequently than 1 week apart

Approval duration — chemotherapy prophylaxisApprove for 6 months when criteria for cancer patients receiving myelosuppressive chemotherapy are met

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical benefit coverage of pegfilgrastim products. Approvals are recommended when the patient meets the policy's Criteria and Dosing for the listed indications. Requests that do not meet the listed Criteria and Dosing for approved indications, or requests for doses outside established dosing documented in this policy, may be denied; such requests will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). All approvals are provided for the duration noted in the policy; when duration is expressed in months, 1 month = 30 days.

Prior authorization recommended for medical benefit coverage
Approvals when Criteria and Dosing are met; extend when criteria continue to be met
Requests for doses outside established dosing considered case-by-case by clinician
All approvals given for specified duration (1 month = 30 days)

Documentation Required

Definitions

Pegfilgrastim — Definition and indications (inv-11)

DefinitionPegfilgrastim is a granulocyte colony stimulating factor (G-CSF) indicated to reduce the incidence of febrile neutropenia in patients receiving myelosuppressive chemotherapy and for select other indications including H-ARS and PBPC mobilization.

Primary oncology indicationDecrease incidence of infection manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer therapy.

Other recognized usesIncludes PBPC mobilization/collection and select biosimilars have H-ARS labeling for acute radiation exposure (see H-ARS entry).

H-ARS — Hematopoietic Syndrome of Acute Radiation Syndrome (inv-12)

DefinitionHematopoietic Syndrome of Acute Radiation Syndrome (H-ARS) — an acute radiation exposure indication for pegfilgrastim to increase survival after myelosuppressive doses.

Background

Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) indicated to decrease the incidence of infection manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy. It is also used for select indications such as hematopoietic syndrome of acute radiation syndrome (H-ARS) and for peripheral blood progenitor cell mobilization/collection in appropriate clinical settings.

Revision History / Policy Changes

2024-10-09material_revisionLatest

Clarified risk-factor examples: age criterion changed to '65 years of age receiving full chemotherapy dose intensity'; liver dysfunction defined as bilirubin >= 2.0 mg/dL; renal dysfunction defined as creatinine clearance <= 50 mL/min; clarified prior neutropenic complication wording.

2024-10-09non-material_revision

Updated example list of colony-stimulating factors to add Ryzneuta and Rolvedon and remove Leukine.

2024-10-09