CurrentCignaPolicy N/A

Colony Stimulating Factors - Pegfilgrastim Products Prior Authorization Policy

Defines prior authorization requirements and medical necessity criteria for pegfilgrastim (Neulasta and listed biosimilars) for Cigna-administered health benefit plans; affects prescribers and payers managing coverage decisions.

Policy Summary

PayerCigna

PolicyColony Stimulating Factors - Pegfilgrastim Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 20, 2023

Next Review DateSep 20, 2023

Key ActionObtain prior authorization with specialist (oncologist/hematologist) documentation for pegfilgrastim; approvals are time-limited (e.g., 6 months for chemotherapy indication).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7products listed

6 mochemotherapy approval

1 moradiation approval

>20%risk threshold

MDSnot covered

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Coverage Criteria for Pegfilgrastim Products

Initial therapy – Cancer patients on myelosuppressive chemotherapy

Covered when ALL of the following are met

Main

Risk scenarios (A)
- i: Receiving anti-cancer medications associated with a high risk (>=20%) of febrile neutropenia based on the chemotherapy regimen
- ii: Receiving regimens with <20% risk AND has at least one prescriber-identified risk factor for febrile neutropenia
- iii: History of neutropenic complication from prior chemotherapy without prior CSF prophylaxis AND a reduced dose or frequency of chemotherapy may compromise treatment outcome

Radiation syndrome (Hematopoietic subsyndrome of acute radiation syndrome)

Covered when ALL of the following are met

Radiation syndrome: Agent prescribed by or in consultation with a physician experienced in treating acute radiation syndromeduration: approve for 1 month

Peripheral Blood Progenitor Cell Transplantation

Covered for stem cell mobilization / PBPC when prescribed by or in consultation with appropriate specialists

PBPC: Peripheral blood progenitor cell transplantation indication: approve one dose if prescribed by or in consultation with an oncologist, hematologist, or transplantation specialist

Use of pegfilgrastim for myelodysplastic syndrome (MDS) is considered experimental, investigational or unproven and is not covered. Limited data exist supporting pegfilgrastim use in MDS, and NCCN MDS guidance does not endorse its use in this population.

Any use of pegfilgrastim products that is not an FDA-approved indication or otherwise supported by available evidence is considered experimental, investigational or unproven and is not covered. Examples include, but may not be limited to, treatment of myelodysplastic syndrome (MDS) where published data are limited and guideline recommendations do not support use.

Chemotherapy Regimens and Regimen-Based Rules

Regimen / Setting	Coverage stance	Rationale / Criteria
Myelosuppressive anti-cancer chemotherapy regimens with high risk (>=20%) of febrile neutropenia
Primary prophylaxis is approved when the chemotherapy regimen is associated with a high risk (>=20%) of febrile neutropenia; medication must be prescribed by or in consultation with an oncologist or hematologist and approvals are provided for 6 months.
Per NCCN and ASCO guidelines, CSF therapy (including pegfilgrastim) is recommended for patients receiving anti-cancer medications with a >20% risk of febrile neutropenia; consider for intermediate (10–20%) risk when patient-specific risk factors are present.

Regimen / Setting	Coverage stance	Rationale / Criteria
Any regimen for myelodysplastic syndrome (MDS)
Use of pegfilgrastim for MDS is considered experimental, investigational or unproven and is not covered.
Only limited data report use of pegfilgrastim for patients with MDS; NCCN MDS guidelines do not mention pegfilgrastim for this population.

Products and Key Coding

Covered products (by brand/biosimilar name)mixedCovered

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

Chemotherapy febrile neutropenia risk — thresholds

Primary prophylaxis threshold>= 20% risk of febrile neutropenia based on the chemotherapy regimen

Consideration for intermediate riskConsider CSF therapy for regimens with 10%–20% risk when patient-specific risk factors are present

Guideline supportNCCN recommends prophylactic CSF for high (>20%) risk regimens and consideration for intermediate (10–20%) risk

Examples of patient risk factorsAge ≥65, prior chemo/radiation, persistent neutropenia, bone marrow involvement, recent surgery/open wounds, liver/renal dysfunction, poor performance status, immunodeficiency (e.g., HIV)

Prior Authorization, Prescriber Requirements, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended/required for pegfilgrastim products. Approvals are time-limited per indication (for example, 6 months for chemotherapy indications and 1 month for acute radiation syndrome). All approvals are provided for the duration noted; when expressed in months, 1 month = 30 days.

Applies to listed pegfilgrastim products (e.g., Neulasta®, Fulphila™, Fylnetra®, Nyvepria™, Stimufend®, Udenyca®, Ziextenzo™).

Note

Prior CSF Consideration

If the patient experienced a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a colony-stimulating factor, pegfilgrastim may be indicated per FDA-approved criteria (see clinical criteria). Examples of colony-stimulating factors include filgrastim products, pegfilgrastim products, and sargramostim products.

Documentation Required

Prescriber Specialty and Authorization Duration

Because of the specialized skills required to evaluate and monitor patients treated with pegfilgrastim, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., oncologist or hematologist for chemotherapy indications). Authorization durations: approve up to 6 months for cancer patients receiving myelosuppressive chemotherapy meeting criteria; approve for 1 month for hematopoietic syndrome of acute radiation syndrome when prescribed by or in consultation with a physician experienced in treating acute radiation syndrome. All approvals are time-limited as described above.

Denial Risk

Not Covered: Myelodysplastic Syndrome (MDS)

Use of pegfilgrastim for myelodysplastic syndrome (MDS) is considered experimental, investigational or unproven and may be denied.

Risk Category Definitions

Febrile neutropenia risk categories

High risk definition>20% risk of febrile neutropenia based on the chemotherapy regimen

Intermediate risk definition10–20% risk of febrile neutropenia; consider prophylactic CSF when additional patient-specific risk factors are present

Guideline recommendationASCO/NCCN: recommend CSF for high-risk regimens; consider for intermediate-risk with risk factors

Prescriber-determined risk factorsPrescriber may identify risk factors (see guideline/examples) to justify CSF in intermediate-risk regimens

Background

Pegfilgrastim is a leukocyte growth factor indicated to decrease the incidence of infection manifested by febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive anti-cancer drugs. Multiple biosimilars to Neulasta are included in the policy. Clinical guidelines (e.g., NCCN, ASCO) recommend colony-stimulating factor use for patients receiving regimens with a >= 20% risk of febrile neutropenia and for certain intermediate-risk (10–20%) regimens when patient-specific risk factors are present.