CurrentCignaPolicy N/A

Colony Stimulating Factors - Pegfilgrastim Products, Rolvedon and Ryzneuta Preferred Specialty Management Policy for Flex, High Performance, and National Preferred Formularies

Defines preferred and non-preferred pegfilgrastim and related colony-stimulating factor products, prior authorization expectations, and exception criteria for Cigna-administered health benefit plans (Flex, High Performance, and National Preferred Formularies). Affects prescribers and pharmacists requesting coverage for listed products.

Policy Summary

PayerCigna

PolicyColony Stimulating Factors - Pegfilgrastim Products, Rolvedon and Ryzneuta Preferred Specialty Management Policy for Flex, High Performance, and National Preferred Formularies

Policy CodePolicy N/A

Change TypeAddition of non-preferred product and formulary scope update

Effective DateN/A

Next Review DateFeb 5, 2025

Key ActionRequire prior authorization and document a trial of at least one Preferred Product (Fulphila or Ziextenzo) before approving a Non-Preferred product.

SourceLink

POLICY UPDATE CHANGES

Ryzneuta (efbemalenograstim alfa-vuxw) was added as a Non-Preferred product and exception criteria were added.

Flex Formulary was added to the policy with the same criteria as High Performance and National Preferred Formularies.

11products listed

2indications listed

Fulphila, Ziextenzopreferred-first trial

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Coverage Criteria

Non-Preferred Product Exception Criteria

Non-Preferred products are covered as medically necessary only when the following exception criteria are met

Neulasta/Fylnetra/Nyvepria/Stimufend/Udenyca non-preferred exception

A: Patient meets the respective standard Colony Stimulating Factors - Pegfilgrastim Products Prior Authorization Policy criteria
B: Patient has tried at least one preferred product (Fulphila or Ziextenzo) AND cannot continue the preferred medication due to a formulation difference in inactive ingredients causing a significant allergy or serious adverse reaction according to the prescriber
Documentation of trial and adverse reaction required

Rolvedon non-preferred exception

A: Patient meets the standard Colony Stimulating Factors - Rolvedon Prior Authorization Policy criteria
B: Patient has tried at least one of Fulphila or Ziextenzo (documentation required)
Previous trial of any pegfilgrastim product counts

Ryzneuta non-preferred exception

A: Patient meets the standard Colony Stimulating Factors - Ryzneuta Prior Authorization Policy criteria
B: Patient has tried at least one of Fulphila or Ziextenzo (documentation required)

Any exception not meeting the stated non-preferred product exception criteria is considered not medically necessary.

Requests for non-preferred products that do not meet the exception criteria are considered not medically necessary.

Coding

No specific CPT/HCPCS/ICD-10 codes listed in this documentmixed

No codes listed

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

All medications (Preferred and Non-Preferred) require prior authorization under the respective standard Colony Stimulating Factors prior authorization policy.

Applies to all pegfilgrastim products and Rolvedon

Step Therapy

Preferred-first Step Requirement

Patients must try at least one Preferred Product (Fulphila or Ziextenzo) prior to approval of a Non-Preferred Product. Prior trial details (including which preferred product was used and dates) should be provided.

Preferred options: Fulphila, Ziextenzo
If the patient meets standard prior authorization criteria but has not tried a Preferred Product, the reviewer will offer a review for the Preferred Product(s) using the respective standard prior authorization policy

Background

Pegfilgrastim and eflapegrastim products are colony stimulating factors used to decrease the incidence of infection manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Certain pegfilgrastim products also have an indication to increase survival after acute radiation exposure (hematopoietic subsyndrome).

Preferred pegfilgrastim products in this program include Fulphila and Ziextenzo. Non-preferred pegfilgrastim and related products listed include Neulasta, Fylnetra, Nyvepria, Stimufend, Udenyca, and pegfilgrastim/eflapegrastim products subject to exception criteria such as Rolvedon and Ryzneuta. The program requires prior authorization for all listed medications and directs a trial of at least one Preferred Product prior to approval of a Non-Preferred Product; documentation of trials and any adverse reaction or intolerance is required.

Exception reviews for non-preferred products require that patients meet the respective standard Colony Stimulating Factors prior authorization criteria and, for many non-preferred agents, a documented trial of a Preferred Product (Fulphila or Ziextenzo) with inability to continue the preferred product due to a formulation-related inactive-ingredient allergy or serious adverse reaction as determined by the prescriber.

Definitions

Biosimilar

DefinitionBiosimilars: products (Fulphila, Fylnetra, Nyvepria, Udenyca, Stimufend, Ziextenzo) approved as biosimilars to Neulasta, having no clinically meaningful differences in safety and effectiveness and sharing the same mechanism of action, route, dosage form, and strength; minor differences in inactive components are allowed.

Examples listed in policyFulphila; Fylnetra; Nyvepria; Udenyca; Stimufend; Ziextenzo (all identified as biosimilars to Neulasta).

Clinical implicationsBiosimilars are considered to have no clinically meaningful differences from the reference product (Neulasta) for safety and effectiveness, supporting interchangeability in clinical decision-making where allowed by policy and benefit terms.

Regulatory allowanceMinor differences in clinically inactive components between biosimilars and Neulasta are permitted by approval standards noted in the policy.

Relation to step therapyA prior trial of any pegfilgrastim product, including Neulasta biosimilars, may satisfy step requirements for certain non-preferred product exceptions per the policy.

Step Therapy Requirements

Step	Requirement	Notes
1	Patient must trial at least one Preferred Product (Fulphila or Ziextenzo) prior to approval of a Non-Preferred Product.	Documentation of the trial is required. A previous trial of any pegfilgrastim product (including Neulasta or its biosimilars) satisfies the trial requirement for some exceptions.
If preferred product cannot be continued	Non-Preferred approval may be granted when the patient cannot continue the preferred medication due to a formulation difference in inactive ingredients causing a significant allergy or serious adverse reaction as determined by the prescriber.	Documentation of the adverse reaction and the trial of the preferred product is required.
Prior authorization	All medications (Preferred and Non-Preferred) must meet the respective standard Colony Stimulating Factors Prior Authorization Policy criteria.	If criterion A (standard PA criteria) is met but the trial requirement is not, offer review for Preferred Product(s) per the standard PA policy.

Biosimilar Guidance

Note

Preferred products (Fulphila, Ziextenzo) — trial required before non-preferred

Fulphila and Ziextenzo are designated Preferred products; a trial of a preferred product is required prior to approval of a Non-Preferred product. Biosimilars (e.g., Fulphila, Fylnetra, Nyvepria, Udenyca, Stimufend, Ziextenzo) are acknowledged as having no clinically meaningful differences from Neulasta.

Preferred products: Fulphila, Ziextenzo
Biosimilars noted as having no clinically meaningful differences from Neulasta