Blue Cross Blue Shield - Iowa CSF Coverage Prior Auth

Coverage Criteria for Colony Stimulating Factors

Exception Criteria for Targeted Short-Acting Products

Coverage for targeted (non-preferred) products is provided when the member meets the following exception criteria:

Targeted short-acting products (Neupogen, Granix, Nypozi, Releuko): Coverage is provided when member meets one of: (a) member has failed treatment with all preferred products due to a documented intolerable adverse event (e.g., rash, nausea, vomiting) and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information; OR (b) member has a documented latex allergy and the prescriber states the member must use latex-free vials and the member had a documented inadequate response or intolerable adverse effect to Nivestym.

Approval will be for 6 months

Exception Criteria for Leukine (sargramostim)

Leukine-specific exceptions:

Leukine (sargramostim): Coverage is provided when member has: (a) a documented inadequate response or intolerable adverse effect to any of the preferred products; OR (b) Leukine is being requested for treatment of uveal melanoma with immunoembolization.

Approval will be for 6 months

Exception Criteria for Certain Targeted Long-Acting Products

Targeted long-acting products (specific pegfilgrastim products) exceptions:

Certain targeted pegfilgrastim products (Armlupeg, Fylnetra, Nyvepria, Stimufend, Udenyca, Udenyca Onbody, Ziextenzo): Coverage is provided when member has failed treatment with all preferred products due to a documented intolerable adverse effect and the adverse event was not an expected adverse event attributed to the active ingredient as described in the prescribing information.

Approval will be for 6 months

Exception Criteria for Rolvedon and Ryzneuta

Rolvedon and Ryzneuta exceptions:

Rolvedon (eflapegrastim) and Ryzneuta (efbemalenograstim): Coverage is provided when member has had a documented inadequate response or intolerable adverse effect to any of the preferred products.

Approval will be for 6 months

Initial Approval — Primary Prophylaxis and Secondary Prophylaxis

Initial approval for prevention of febrile neutropenia (Rolvedon example shown):

Initial therapy for prevention of FN: Authorization of 6 months may be granted when ALL of the following are met: (1) Rolvedon will not be used in combination with other colony stimulating factors within any chemotherapy cycle; (2) member will not be receiving chemotherapy and radiation therapy at the same time; (3) Rolvedon will not be administered with weekly chemotherapy regimens; AND (4) one of the following: (a) primary prophylaxis for myelosuppressive anti-cancer therapy expected to result in >20% incidence of febrile neutropenia (see Appendix A); OR (b) therapy expected to result in 10–20% FN risk and the member is at high risk for FN because of bone marrow compromise, comorbidities, or other patient-specific risk factors (see Appendix C); OR (c) therapy expected to result in <10% FN risk and the member has at least 2 patient-related risk factors (see Appendix C); OR (d) secondary prophylaxis after a prior febrile neutropenic complication or dose-limiting neutropenic event from a prior similar chemotherapy cycle with the same dose and schedule planned.

Applies to members with solid tumors and non-myeloid malignancies; authorization up to 6 months

Other Indications

Other indications eligible for authorization:

Other approved indications: Authorization of 6 months may be granted for: (1) stem cell transplantation-related indications; (2) hematopoietic acute radiation syndrome (treatment for radiation-induced myelosuppression following a radiological/nuclear incident); and (3) hairy cell leukemia (including members with hairy cell leukemia with neutropenic fever following chemotherapy).

Continuation of Therapy (coverage criteria)

Continuation of therapy:

Continuation: All members (including new members) requesting continuation of therapy must meet all initial authorization criteria. If initial criteria are not met, continued therapy is considered not medically necessary.

Includes new members

This policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations for FEP members are governed by the applicable FEP contract language in effect at the time services were rendered; verify individual member benefits and contract terms prior to authorization.

Appendix lists of chemotherapy regimens are not comprehensive. Absence of an agent or regimen from Appendix B does not imply it is low risk — other agents or regimens may have an intermediate or high risk for febrile neutropenia and should be evaluated clinically for prophylaxis consideration.

Rolvedon is considered not medically necessary for members who do not meet the initial authorization criteria described in this policy. Continuation requests (including for new members) must meet all initial authorization requirements; failure to meet those criteria will result in a determination of not medically necessary.

Initial Therapy — Primary Prophylaxis

Initial authorization for primary prophylaxis:

Initial Therapy — Primary Prophylaxis: Authorization of 6 months may be granted when ALL of the following are met: (1) agent will not be used with other colony stimulating factors within any chemotherapy cycle; (2) member will not be receiving chemotherapy and radiation therapy concurrently; (3) agent will not be administered with weekly chemotherapy regimens; AND (4) one of: (a) primary prophylaxis for regimens with >20% FN risk; (b) 10–20% FN risk with additional high-risk patient factors (bone marrow compromise, comorbidities, other factors); (c) <10% FN risk with ≥2 patient-related risk factors; OR (d) secondary prophylaxis after prior FN complication or dose-limiting neutropenic event when same dose/schedule is planned.

Authorization up to 6 months; applies to solid tumors and non-myeloid malignancies

Continuation of Therapy Criteria

Continuation of Therapy — continuation authorization criteria

Continuation authorization criteria:

Continuation of Therapy: Members requesting continuation of colony stimulating factor therapy must meet all initial authorization criteria to continue therapy. Members who do not meet initial criteria are considered not medically necessary for continued therapy.

Includes new members

Provider Actions, Documentation and Billing Requirements

Prior Authorization

Prior Authorization and Dosing Limits

Prior authorization is required for targeted colony stimulating factor products and for Rolvedon per the policy. Authorizations for Rolvedon may be granted for up to 6 months when all applicable medical necessity criteria are met. Approvals may be subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence-based practice guidelines.

Prior auth duration: up to 6 months for Rolvedon when criteria met
Dosing limits: subject to FDA labeling, compendia, and guidelines

Documentation Required

Required Documentation for Primary Prophylaxis

Providers must document the medical rationale when requesting primary prophylaxis of febrile neutropenia, including the member's diagnosis and the specific chemotherapeutic regimen. For intermediate-risk regimens (10-19% risk), provide documentation of patient-specific risk factors that place the member at high risk for febrile neutropenia (see Appendix B and C).

Procedure, Billing and Risk Band Coding

Procedure/Billing HCPCS and J-codesHCPCS

C9399	Unclassified drugs or biologicals
C9173	Injection, filgrastim-txid (nypozi), biosimilar, 1 microgram (cancelled 7/1/2025)
J1442	Injection, filgrastim (g-csf), excludes biosimilars, 1 microgram (Neupogen)
J1447	Injection, tbo-filgrastim, 1 mcg
J1449	Injection, eflapegrastim-xnst, (Rolvedon) 0.1 mg (effective 4/1/2023)
J2820	Injection, sargramostim (gm-csf), 50 micrograms (Leukine)
J3590	Unclassified biologicals
J9361	Injection, efbemalenograstim alfa-vuxw, 0.5 mg (Ryzneuta)
Q5108	Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5mg
Q5111	Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5mg

1–10 of 16

1/2

Febrile neutropenia risk bands

High risk>20% estimated incidence of febrile neutropenia (see Appendix A for selected regimens)

Intermediate risk10–20% estimated incidence of febrile neutropenia (see Appendix B for selected regimens)

Low risk<10% estimated incidence of febrile neutropenia

Age threshold

Age thresholdAge greater than or equal to 65 years is a patient risk factor for febrile neutropenia

ContextAge ≥65 listed among patient-level risk factors that increase FN risk when regimen risk is intermediate (10–20%) or low (<10%)

Step Therapy Requirements

Step	Requirement	Notes
1
Failure of all preferred products (Nivestym, Zarxio for short-acting; Fulphila, Neulasta, Neulasta Onpro for long-acting) due to a documented intolerable adverse event or documented inadequate response is required before coverage of targeted products (e.g., Neupogen, Granix, Nypozi, Releuko, Armlupeg, Fylnetra, Nyvepria, Stimufend, Udenyca, Udenyca Onbody, Ziextenzo).
Exceptions apply when documented latex allergy requires latex-free vials (with inadequate response or intolerable effect to Nivestym), Leukine-specific indications (e.g., uveal melanoma with immunoembolization), or other documented clinical justifications per policy. Approvals for exceptions are generally for up to 6 months.

Preferred Biosimilars and Related Guidance

Note

Preferred short-acting biosimilar: Nivestym (filgrastim‑aafi)

Nivestym (filgrastim‑aafi) is identified in the policy as a preferred short‑acting filgrastim biosimilar.

Note

Preferred short-acting biosimilar: Zarxio (filgrastim‑sndz)

Zarxio (filgrastim‑sndz) is identified in the policy as a preferred short‑acting filgrastim biosimilar.

Note

Preferred long-acting biosimilar: Fulphila (pegfilgrastim‑jmdb)

Fulphila (pegfilgrastim‑jmdb) is listed as a preferred long‑acting pegfilgrastim biosimilar in the policy.

Note

Preferred long-acting products: Neulasta syringe and Neulasta Onpro

Key Definitions

Primary prophylaxis of febrile neutropenia

DefinitionPrimary prophylaxis of febrile neutropenia: use of colony stimulating factors to prevent FN in cancer patients receiving myelosuppressive chemotherapy when regimen and patient risk criteria are met

Regimen risk for primary prophylaxisPrimary prophylaxis indicated for regimens expected to cause >20% FN, or 10–20% FN when patient is high risk, or <10% FN when patient has ≥2 risk factors

Authorization durationAuthorization of up to 6 months may be granted for prevention of FN when criteria are met

Febrile neutropenia (FN) risk — selected regimens and patient risk factors

Selected regimens (examples)Chemotherapy regimens with estimated 10–20% FN incidence are listed in Appendix B (examples include docetaxel ± trastuzumab; AC + sequential docetaxel; FOLFIRINOX; cisplatin/paclitaxel; carboplatin/paclitaxel)

Patient risk factors

Background

Colony stimulating factors (CSFs) — including short-acting filgrastim products and long-acting pegfilgrastim products, as well as eflapegrastim and sargramostim — are used to prevent and treat neutropenia associated with myelosuppressive chemotherapy and other clinical situations. CSFs are indicated for primary prophylaxis of febrile neutropenia in patients receiving chemotherapy regimens with a high risk of FN (>20%), for selected regimens with intermediate risk (10–20%) when patient-specific risk factors increase overall risk, and for secondary prophylaxis after prior neutropenic complications. Authorizations and dosing should follow FDA labeling and accepted compendia; prior authorization may be granted for up to 6 months for prevention of febrile neutropenia and other covered indications listed in the policy.

Revision History

2026-02-19policy_effective_dateLatest

Policy 05.02.41 became effective with revisions finalized in January 2026.

2026-01-01policy_reviewed_revised

Policy was reviewed and revised in January 2026 (document notes review and revision in January 2026).

2026-01-01policy_reviewed_revised

OpenPayer

Colony stimulating factor (CSF) products coverage and prior authorization

Coverage Criteria for Colony Stimulating Factors

Initial Therapy — Primary Prophylaxis

Continuation of Therapy Criteria

Provider Actions, Documentation and Billing Requirements

Procedure, Billing and Risk Band Coding

Step Therapy Requirements

Preferred Biosimilars and Related Guidance

Key Definitions

Background

Revision History