CurrentCignaPolicy N/A

Colony Stimulating Factors - Pegfilgrastim Products, Rolvedon and Ryzneuta Preferred Specialty Management Policy

Defines Cigna's Preferred Specialty Management program and exception criteria for pegfilgrastim products (including Rolvedon and Ryzneuta) for applicable formularies; applies to providers requesting coverage under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyColony Stimulating Factors - Pegfilgrastim Products, Rolvedon and Ryzneuta Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateFeb 11, 2026

Key ActionObtain prior authorization and document a trial of at least one Preferred Product (e.g., Fulphila or Ziextenzo) to support approval for Non-Preferred pegfilgrastim products.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9branded pegfilgrastim and eflapegrastim/efbemalenograstim products listed

Preferred→Non-Preferredstep therapy requirement

Documentation requireddocumentation required for prior trial

Rolvedon, Ryzneutaspecial exception pathways

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage with exception criteria

Coverage is provided when standard Colony Stimulating Factors prior authorization criteria are met; Non-Preferred products require additional exception criteria.

General: Patient meets the standard Colony Stimulating Factors - Pegfilgrastim Products Prior Authorization Policy criteria

Standard prior authorization required for all products

Non-Preferred product exception (Neulasta biosimilars listed as Non-Preferred): A) Patient meets the standard Colony Stimulating Factors - Pegfilgrastim Products Prior Authorization Policy criteria; AND B) Patient has tried at least one Preferred product (Fulphila or Ziextenzo) with documentation; AND C) Patient cannot continue the Preferred product due to a formulation difference in inactive ingredient(s) which, per prescriber, would cause a significant allergy or serious adverse reaction

If criterion A is met but B and/or C are not met, offer review for the Preferred product(s)

Rolvedon exception: A) Patient meets the standard Colony Stimulating Factors - Rolvedon Prior Authorization Policy criteria; AND B) Patient has tried at least one of Fulphila or Ziextenzo (documentation required). A previous trial of any pegfilgrastim product (Neulasta or biosimilars) also satisfies this requirement (documentation required)

If criterion A is met but B is not met, offer review for the Preferred product(s)

Ryzneuta exception: A) Patient meets the standard Colony Stimulating Factors - Ryzneuta Prior Authorization Policy criteria; AND B) Patient has tried at least one of Fulphila or Ziextenzo (documentation required). A previous trial of any pegfilgrastim product (Neulasta or biosimilars) also satisfies this requirement (documentation required)

If criterion A is met but B is not met, offer review for the Preferred product(s)

Any exception request for a Non‑Preferred product that does not meet the specific Non‑Preferred product exception criteria described in this policy is considered not medically necessary. Preferred Products are listed as Fulphila and Ziextenzo; requests for Non‑Preferred products must meet the exception criteria to be approved.

Requests for Non‑Preferred products that do not meet the exception criteria, including the required prior trial and documentation, are considered not medically necessary. To meet the Non‑Preferred product exception criteria the patient must: A) meet the applicable standard Prior Authorization Policy for the product class; B) have tried at least one Preferred Product (Fulphila or Ziextenzo) with documentation; and C) be unable to continue the Preferred product because of a prescriber‑documented formulation difference in inactive ingredients expected to cause a significant allergy or serious adverse reaction. For Rolvedon and Ryzneuta, a previous trial of any pegfilgrastim product (including Neulasta or biosimilars) also satisfies the trial requirement (documentation required). If the standard PA criteria are met but exception criterion B and/or C are not, offer review for the Preferred product(s).

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization required — All products (Preferred and Non-Preferred) require meeting the respective standard Colony Stimulating Factors Prior Authorization Policy criteria. All approvals are provided for the duration noted in the respective standard Colony Stimulating Factors Prior Authorization Policy.

All products require prior authorization per the applicable Colony Stimulating Factors prior authorization policy.

Step Therapy

Preferred Product Trial Required

Preferred product trial required — The patient must try at least one Preferred Product prior to approval of a Non-Preferred Product. If the patient meets the standard prior authorization criteria but has not tried a Preferred Product, a review will be offered for the Preferred Product(s) under the standard prior authorization policy.

Patient must try at least one Preferred Product (e.g., Fulphila or Ziextenzo) before Non-Preferred approval.
A prior trial of any pegfilgrastim product (including Neulasta or biosimilars) may satisfy the requirement where noted.

Documentation Required

Documentation Required for Prior Product Trial

Documentation for prior product trial — Documentation is required to support previous use of the Preferred drug(s). Acceptable documentation includes, but is not limited to, chart notes, prescription claims records, prescription receipts, and/or other information. All documentation must include patient-specific identifying information.

Acceptable documentation: chart notes, prescription claims, receipts, or similar records.
Documentation must include patient identifiers.
Documentation required where noted in exception criteria (e.g., Fulphila or Ziextenzo trial).

Billing Rule

Billing and Coding Requirements

Billing and coding requirements — Claims submitted without covered diagnosis or procedure codes per the applicable coverage policy will be denied. When billing, providers must use the most appropriate codes as of the effective date of submission.

Claims without covered diagnosis/procedure codes under the applicable coverage policy will be denied.
Use the most appropriate codes as of the date of submission.

Initial Therapy Requirements

Initial therapy requirements

Initial coverage requires prior authorization and, for Non-Preferred products, a trial of a Preferred product with documentation.

Initial coverage general: Meet the standard Colony Stimulating Factors Prior Authorization Policy criteria

Prior authorization required for all products

Non-Preferred initial exception: For Non-Preferred products, patient must have tried at least one Preferred product (Fulphila or Ziextenzo) with documentation. For Rolvedon and Ryzneuta, a previous trial of any pegfilgrastim product (Neulasta or biosimilars) also satisfies the trial requirement (documentation required)

Documentation may include chart notes, prescription claims records, prescription receipts, or other patient-specific records

Step Therapy and Product Trial Table

Step	Requirement	Documentation
1	Patient must trial at least one Preferred Product (Fulphila or Ziextenzo) prior to approval of a Non‑Preferred product.	Documentation of the prior trial is required (e.g., chart notes, prescription claims records, prescription receipts); documentation must include patient‑specific identifying information.
2	If patient meets the respective standard Colony Stimulating Factors prior authorization criteria but has not tried a Preferred Product, offer review for the Preferred Product(s) under the standard PA policy.	Same documentation requirements as above when documenting prior therapy or when submitting for Preferred product review.
3	For Rolvedon and Ryzneuta exceptions, a prior trial of Fulphila or Ziextenzo is required; note that a previous trial of any pegfilgrastim product (Neulasta or biosimilars) also satisfies this requirement.	Documentation required as above to demonstrate prior trial; prior trial of any pegfilgrastim product must be documented.

Biosimilars and Preferred Products

Note

Neulasta and biosimilar guidance; Preferred Products encouraged

Policy lists approved biosimilars to Neulasta and encourages use of Preferred Products such as Fulphila and Ziextenzo prior to Non-Preferred products; a previous trial of any pegfilgrastim product (Neulasta or biosimilars) may satisfy exception requirements for certain agents.

Fulphila and Ziextenzo are named Preferred Products.
Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca, and Ziextenzo were approved as biosimilars to Neulasta (per overview).
A previous trial of any pegfilgrastim product (Neulasta, biosimilars) also satisfies the trial requirement for Rolvedon and Ryzneuta (documentation required).

Key Definitions

Biosimilar definition and relevance to Neulasta

DefinitionBiosimilar: a product approved as a biosimilar to Neulasta that demonstrates no clinically meaningful differences in safety and effectiveness and has the same mechanism of action, route of administration, dosage form, and strength; minor differences in clinically inactive components are allowed.

Relevance to NeulastaFulphila, Fylnetra, Nyvepria, Udenyca, Stimufend, and Ziextenzo are approved biosimilars to Neulasta.

Clinical implicationBiosimilars have equivalent clinical effectiveness to Neulasta for reducing incidence of infection manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy.

Formulation noteBiosimilars may differ in clinically inactive components despite having the same active drug characteristics.

Policy relevanceThe policy lists these biosimilars and encourages use of Preferred Products; exception criteria apply when requesting Non-Preferred products.

OpenPayer

Colony Stimulating Factors - Pegfilgrastim Products, Rolvedon and Ryzneuta Preferred Specialty Management Policy

Coverage Criteria and Exceptions

Provider Requirements and Actions

Initial Therapy Requirements

Step Therapy and Product Trial Table

Biosimilars and Preferred Products

Key Definitions

Site of Care

Background