CurrentCignaPolicy IP0745

Ryzneuta

Cigna coverage and prior authorization policy for Ryzneuta (efbemalenograstim alfa-vuxw) for prevention of febrile neutropenia in adults with non-myeloid malignancies receiving myelosuppressive chemotherapy.

Policy Summary

PayerCigna

PolicyRyzneuta

Policy CodePolicy IP0745

Change TypeNew policy

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization; approve when patient meets the policy's criteria and dosing (20 mg subcutaneous, up to 12 months).

SourceLink

POLICY UPDATE CHANGES

New policy established for Ryzneuta coverage.

20 mgapproved subcutaneous dose

12 monthsmax approval duration

J9361HCPCS code

ExcludedPBPC mobilization

Coverage Criteria

Initial Therapy (FDA indication)

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Initial Therapy (FDA Indication) Criteria

Initial Therapy (FDA indication)

Initial approval criteria for FDA-approved indication:

Initial Therapy: Patient is >= 18 years of age AND has a non-myeloid malignancy receiving myelosuppressive chemotherapy associated with an increased risk of febrile neutropenia; Dosing: 20 mg by subcutaneous injection no more frequently than once every 2 weeks; Approve for up to 12 months when criteria are met.20 mg per dose

Receipt of sample product does not satisfy criteria. NCCN: use for regimens with >20% risk; consider for 10-20% with risk factors.

Continuation Therapy Criteria

Continuation Therapy

Extended approvals are allowed if the patient continues to meet the criteria:

Continuation: Patient continues to meet the initial therapy criteria and dosing (including age, diagnosis, and dosing interval). Approvals may be extended up to the policy maximum duration for the FDA indication (up to 12 months).

Approvals measured in months use 30-day months; requests for doses outside established dosing considered case-by-case by a clinician.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization required — Prior Authorization is required for coverage of Ryzneuta. Approval is recommended for patients who meet the policy Criteria and Dosing. Extended approvals are allowed if the patient continues to meet Criteria and Dosing. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician. Approvals are provided for the duration noted in the policy (months = 30 days).

Prior Authorization required
Approvals provided for specified duration (1 month = 30 days)
Dose exceptions reviewed by Medical Director or Pharmacist

Step Therapy

Step therapy — No step therapy requirements or comparator agent sequence are specified for Ryzneuta in this policy.

Documentation Required

Prescriber & Dosing Documentation

Prescriber and dosing documentation — Approval requires Ryzneuta to be prescribed by or in consultation with a physician who specializes in the condition being treated. For the FDA-approved indication listed in this policy: patient must be ≥ 18 years of age. Dosing: approve 20 mg by subcutaneous injection no more frequently than once every 2 weeks. Receipt of sample product does not satisfy criteria.

Prescriber must be specialist or consult with specialist
Patient age requirement: ≥ 18 years (for listed indication)
Dosing: 20 mg SC every ≥2 weeks
Samples do not satisfy criteria

Denial Risk

Denial Triggers & Coding

Denial triggers — Claims submitted without covered diagnosis/procedure codes or with codes not listed in the policy will be denied. Providers must bill using the most appropriate codes effective on the date of service; deleted or non-effective codes may not be eligible for reimbursement.

Claims without covered diagnosis/procedure codes will be denied
Use most appropriate, effective codes as of date of service
Deleted or not-yet-effective codes may be ineligible

Step Therapy

Step	Requirement / Notes
No specific step therapy sequence specified in this policy	Policy references NCCN recommendations for colony‑stimulating factor (CSF) use: prophylactic CSF is recommended for regimens with high (>20%) risk of febrile neutropenia and considered for intermediate (10–20%) risk with additional patient risk factors; Ryzneuta has been studied for prophylactic use only.
No required prior failure of another agent before approval	Prior Authorization is required for Ryzneuta; approval is recommended for patients who meet the policy's coverage criteria and dosing.

Quantity Limits

inv-14: Ryzneuta — approved subcutaneous dose 20 mg

Approved subcutaneous dose20 mg by subcutaneous injection no more frequently than once every 2 weeks

Maximum approval duration (FDA indication)Up to 12 months when criteria are met

Age requirementPatient must be ≥ 18 years of age

Administration guidanceDosage, frequency, duration, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature

Site of Care

Note

Site of care must be clinically appropriate (no specific restriction)

Site of care should be reasonable and clinically appropriate; the policy does not impose a specific site-of-care restriction.

Dosage, frequency, duration, and site of care should be supported by evidence-based literature and clinically appropriate.

Definitions

inv-10: PBPC mobilization definition — Peripheral Blood Progenitor Cell (PBPC) mobilization; Ryzneuta not indicated for this use

DefinitionPBPC mobilization is the use of agents to mobilize hematopoietic stem cells for collection prior to transplantation

Policy stanceRyzneuta is not indicated for PBPC mobilization and is excluded for this use

Limitation of use (product labeling)Ryzneuta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation

Not medically necessary statementUse of Ryzneuta for PBPC collection and therapy is considered not medically necessary

Background

Ryzneuta is a granulocyte colony‑stimulating factor (G‑CSF) indicated to reduce the incidence of infection manifested by febrile neutropenia in adults with non‑myeloid malignancies who are receiving myelosuppressive chemotherapy associated with a clinically significant risk of febrile neutropenia. The product has a limitation of use: it is not indicated for mobilization of peripheral blood progenitor cells (PBPCs), and safety and effectiveness in pediatric patients have not been established.