Colony Stimulating Factors - Rolvedon

Coverage Summary

Coverage stance: covered_with_criteria. Scope: defines medical-benefit coverage, prior authorization, clinical criteria, dosing limits, and exclusions for Rolvedon (eflapegrastim-xnst) subcutaneous injection under Cigna health benefit plans. Policy effective: 2026-01-15; Last review: 2026-01-15.

Policy-level summary: Rolvedon is a granulocyte colony stimulating factor indicated to decrease the incidence of infection manifested by febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy when criteria are met. It is not indicated for mobilization of peripheral blood progenitor cells (PBPCs). Safety and effectiveness in pediatric patients have not been established.

Thresholds and Quick Facts

Age>= 18 years

High risk threshold>= 20% risk based on chemotherapy regimen

Intermediate risk10% to 20% — consider when additional risk factors are present

Renal dysfunction example thresholdcreatinine clearance < 50 mL/min

Liver dysfunction example thresholdbilirubin > 2.0 mg/dL

Covered Indications (quick fact)2

Primary HCPCS code listed (quick fact)J1449 (Injection, eflapegrastim-xnst, 0.1 mg)

Primary Exclusion (quick fact)Mobilization of peripheral blood progenitor cells (PBPC) — not indicated

Initial Therapy Criteria — Chemotherapy Indication

Medically Necessary - FDA-Approved Indication: Cancer in a Patient Receiving Myelosuppressive Chemotherapy

Rolvedon is considered medically necessary when ONE of the following are met:

ALL of the following

ONE of
- High risk regimen: Patient is ≥ 18 years of age and is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (the risk is at least 20% based on the chemotherapy regimen)Age >= 18; High risk >= 20%
- Intermediate risk with risk factors: Patient is ≥ 18 years of age and is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia but the risk is less than 20% based on the chemotherapy regimen, AND patient has at least one risk factor for febrile neutropenia according to the prescriber

Initial Therapy Criteria — Hematopoietic Acute Radiation Syndrome (H-ARS)

Medically Necessary - Other Use with Supportive Evidence: Hematopoietic Acute Radiation Syndrome (H-ARS)

Approve for HARS when BOTH criteria are met:

H-ARS criteria

Patient is >= 18 years of ageAge >= 18
The medication is prescribed by or in consultation with a physician who has expertise in treating acute radiation syndrome

Billing Rule

Dosing limit — H-ARS

Approve two doses of up to 13.2 mg by subcutaneous injection no more frequently than 1 week apart for H-ARS.

Continuation / Reauthorization Criteria

Continuation/reauthorization guidance: 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; when authorized in months, 1 month = 30 days.

Approval durations in the policy: the chemotherapy indication is approved for specified durations (example: approve for 6 months when criteria met) and H-ARS is approved for 1 month when criteria met. There are no separate continuation criteria trees in the brief; continued approvals follow the same criteria and dosing limits documented in the policy.

Documentation Required

Duration and reauthorization

Approvals are provided for the duration noted in the policy. Extended approvals are allowed only if the patient continues to meet the criteria and dosing.

When authorization is provided in months, 1 month = 30 days
Continued medical necessity must be met for extensions/extended approvals

Not Medically Necessary / Exclusions

Rolvedon for any other use is considered not medically necessary, including but not limited to:

PBPC mobilization: Peripheral blood progenitor cell collection and therapy (mobilization of PBPCs for hematopoietic stem cell transplantation)
Rolvedon is not indicated for mobilization of peripheral blood progenitor cells.
Other uses: Any use not described in the above medically necessary sections

Denial Risk

Applicable Codes

Applicable HCPCS for medically necessary useHCPCSCovered

J1449

Injection, eflapegrastim-xnst, 0.1 mg (Code effective 04/01/2023)

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for medical benefit coverage of Rolvedon. Approval is granted only if the patient meets the policy Criteria and the specified Dosing. Approval durations are specified in the policy and extended approvals require ongoing medical necessity.

J1449

Billing Rule

Dosing constraints (summary)

Chemotherapy: Approve up to 13.2 mg SC no more frequently than once every 2 weeks. H-ARS: Approve two doses up to 13.2 mg SC no more frequently than 1 week apart.

J1449

Clinical Evidence & References

NCCN guidance: The NCCN Hematopoietic Growth Factors Clinical Practice Guidelines (v1.2025, Oct 11, 2024) recommend CSF prophylaxis for regimens with a high (>20%) risk of febrile neutropenia and consideration of CSF for intermediate (10–20%) risk when additional risk factors are present.

Manufacturer prescribing information: Rolvedon prescribing information (Spectrum; June 2023) is referenced for the chemotherapy indication and product information.

H-ARS / Neulasta labeling: Definitive dosing for Rolvedon in H-ARS has not been established; Neulasta labeling recommends two subcutaneous doses one week apart for H-ARS and Rolvedon is available as a 13.2 mg single-dose prefilled syringe.

Background

Background: Rolvedon (eflapegrastim-xnst) is a granulocyte colony stimulating factor indicated to decrease the incidence of infection as manifested by febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy. It is not indicated for mobilization of peripheral blood progenitor cells. Safety and effectiveness in pediatric patients have not been established.

Supporting definition: Hematopoietic acute radiation syndrome (H-ARS) is defined as radiation-induced myelosuppression following a radiologic/nuclear incident, and the policy includes an H-ARS indication with specific adult age and prescriber expertise requirements.

Policy Metadata

PayerCigna

Policy TitleColony Stimulating Factors - Rolvedon

Policy NumberIP0526

Effective Date2026-01-15

Last Review

Revision History

2026-01-15materialLatest

Policy title and chemotherapy coverage statement updated to 'Cancer in a Patient Receiving Myelosuppressive Chemotherapy'; clarified criteria structure requiring ONE of: high-risk regimen (≥20%), intermediate-risk (10–20%) with ≥1 risk factor, or prior neutropenic complication where chemotherapy cannot be reduced; dosing for chemotherapy: approve up to 13.2 mg SC no more frequently than once every 2 weeks.

2026-01-15materialLatest

Added Hematopoietic Acute Radiation Syndrome (H-ARS) as a new condition of approval with a new dosing limitation: approve two doses up to 13.2 mg SC no more frequently than 1 week apart; approval duration specified as 1 month when criteria met.