Currentculinary health fundPolicy N/A

Ryzneuta (efbemalenograstim) — Colony Stimulating Factors coverage criteria

Defines prior authorization and medical necessity criteria for coverage of Ryzneuta (efbemalenograstim) for adults with non-myeloid malignancies receiving myelosuppressive chemotherapy and for hematopoietic acute radiation syndrome; excludes PBPC mobilization. Affects prescribers, requesters, and payers within the plan.

Policy Summary

Payerculinary health fund

PolicyRyzneuta (efbemalenograstim) — Colony Stimulating Factors coverage criteria

Policy CodePolicy N/A

Change TypeMaterial revisions and addition of H-ARS indication

Effective DateN/A

Next Review DateOct 29, 2025

Key ActionObtain prior authorization; approvals provided for specified durations (6 months for chemotherapy indication; 1 month for H-ARS).

SourceLink

POLICY UPDATE CHANGES

Examples of risk factors for febrile neutropenia were updated to specify '> 65 years of age receiving full chemotherapy dose intensity', liver dysfunction as 'bilirubin > 2.0 mg/dL', renal dysfunction as 'creatine clearance < 50 mL/min', and clarified HIV patients as 'a patient with HIV infection and low CD4 counts.'

Requirement wording changed from 'previous chemotherapy cycle' to 'prior chemotherapy cycle' for neutropenic complication history.

Radiation Syndrome (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]) was added as an Other Use with Supportive Evidence with a dosing limitation of two doses.

≥18minimum age for covered indications

20 mgmaximum single dose approved

6 mo

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Coverage and Medical Necessity Criteria

Initial therapy - chemotherapy

Approve for 6 months if the patient meets ALL of the following (A, B, and C):

Chemotherapy indication

Risk criteria: i. Receiving myelosuppressive anti-cancer medications associated with high risk (>= 20%) of febrile neutropenia based on the chemotherapy regimen.; OR ii. Receiving myelosuppressive anti-cancer medications with risk <20% AND has at least ONE prescriber-identified risk factor for febrile neutropenia (examples: age >65 years receiving full chemotherapy dose intensity; prior chemotherapy or radiation; persistent neutropenia; bone marrow involvement by tumor; recent surgery/open wounds; liver dysfunction (bilirubin >2.0 mg/dL); renal dysfunction (creatinine clearance <50 mL/min); poor performance status; HIV with low CD4 counts).; OR iii. Had a neutropenic complication from a prior chemotherapy cycle and did not receive prophylaxis with a colony stimulating factor AND a reduced dose or frequency of chemotherapy may compromise treatment outcome.

Age: A) Patient is >= 18 years of age.

H-ARS (radiation syndrome)

Approve for 1 month if the patient meets BOTH of the following (A and B):

H-ARS indication: A) Patient is >= 18 years of age; AND B) Medication prescribed by or in consultation with a physician who has expertise in treating acute radiation syndrome.

Dosing: Approve two doses of up to 20 mg by subcutaneous injection no more frequently than 1 week apart.

Coverage for Ryzneuta is not recommended when the request is for mobilization of peripheral blood progenitor cells (PBPCs) for hematopoietic stem cell transplantation. The Ryzneuta prescribing information includes a limitation of use that the product is not indicated for PBPC mobilization, and the policy excludes PBPC collection and therapy from recommended approval. Coverage is also not recommended for circumstances that are not listed in the Recommended Authorization Criteria.

Per the FDA limitation of use and this policy, use of Ryzneuta for peripheral blood progenitor cell (PBPC) collection and therapy is not recommended. The product labeling explicitly states Ryzneuta is not indicated for mobilization of PBPCs for hematopoietic stem cell transplantation, and requests for this indication will not be recommended for approval under the policy.

Covered Chemotherapy Regimens and H-ARS Dosing

Regimen / Scenario	Coverage
Chemotherapy regimens with high risk of febrile neutropenia (≥ 20% based on the chemotherapy regimen)	Covered
Chemotherapy regimens with risk < 20% when the patient has ≥1 prescriber-identified risk factor for febrile neutropenia (examples: age > 65 receiving full dose intensity; prior chemotherapy or radiation; persistent neutropenia; bone marrow involvement by tumor; recent surgery/open wounds; liver dysfunction - bilirubin > 2.0 mg/dL; renal dysfunction - creatinine clearance < 50 mL/min; poor performance status; HIV with low CD4 counts)	covered with criteria
Patients with a prior neutropenic complication from a prior chemotherapy cycle who did not receive prophylaxis with a colony stimulating factor, where reduced dose or frequency of chemotherapy may compromise treatment outcome	covered with criteria

Indication	Dosing / Coverage
Hematopoietic acute radiation syndrome (H-ARS)	Two doses of up to 20 mg by subcutaneous injection, no more frequently than 1 week apart; coverage approved with criteria (1-month authorization)

Product Presentation, Age and Lab Thresholds

Product presentationNDC

NDC	Ryzneuta available as 20 mg/mL single-dose prefilled syringe (NDC not specified in document)

Product presentation (alternate entry)mixed

20 mg/mL

Single-dose prefilled syringe formulation of Ryzneuta

inv-06: Age — >= 18 years

Age requirementPatient must be ≥ 18 years of age for covered indications

Pediatric useSafety and effectiveness in pediatric patients have not been established

Applies to indicationsRequirement listed for both chemotherapy and H-ARS indications

inv-07: Bilirubin — > 2.0 mg/dL

Bilirubin thresholdLiver dysfunction defined as bilirubin > 2.0 mg/dL

Context of useUsed as an example risk factor for febrile neutropenia when regimen risk <20%

Source clarification

Therapy Line and Prophylactic Use

prophylactic use during myelosuppressive chemotherapy

Applicable regimens: Patients receiving myelosuppressive anti-cancer drugs associated with high (>=20%) risk of febrile neutropenia, or intermediate risk (10-20%) with additional patient risk factors, or patients with prior neutropenic complications where dose reduction would compromise outcome.

Prior Authorization, Prescriber Requirements, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for Ryzneuta. Approvals are provided for specified durations: 6 months for the chemotherapy (myelosuppressive chemotherapy) indication and 1 month for the H-ARS (hematopoietic acute radiation syndrome) indication. All approvals are provided for the duration noted in the policy; when duration is stated in months, 1 month = 30 days.

Approve for 6 months for cancer patients receiving myelosuppressive chemotherapy when criteria are met
Approve for 1 month for H-ARS when criteria are met
Extended approvals may be allowed if patient continues to meet criteria and dosing

Documentation Required

Dose Exceptions Reviewed Case-by-Case

Requests for doses outside of the established dosing documented in this policy will be reviewed on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacy Medical Director).

Key Definitions and Risk Categories

inv-14: PBPC mobilization — Limitation of use: not indicated for mobilization of peripheral blood progenitor cells (PBPCs) for hematopoietic stem cell transplantation

Limitation of useRyzneuta is not indicated for mobilization of peripheral blood progenitor cells (PBPCs) for hematopoietic stem cell transplantation

Coverage stanceCoverage not recommended for PBPC mobilization per policy exclusions

FDA statementLimitation of use appears in the product overview/labeling

inv-15: Chemotherapy febrile neutropenia risk categories — High risk >20%; intermediate 10–20%

High-risk definitionHigh risk: chemotherapy regimens associated with >20% incidence of febrile neutropenia

Intermediate-risk definitionIntermediate risk: 10–20% incidence; consider CSF with additional patient risk factors

Product Background

Ryzneuta is a granulocyte colony stimulating factor (G-CSF) indicated to decrease the incidence of infection manifested by febrile neutropenia in adults with non-myeloid malignancies who are receiving myelosuppressive anti-cancer therapy associated with a clinically significant risk of febrile neutropenia. The label also notes that safety and effectiveness in pediatric patients have not been established and includes a limitation of use excluding PBPC mobilization.