ModifiedmhnPolicy Cp.Phar.296

Pegfilgrastim and Biosimilars clinical policy

Clinical policy governing coverage, redirection/preferred biosimilars, indications (including acute radiation syndrome and mobilization prior to autologous transplantation), state-specific Appendix E listings, and formulary/preference updates for pegfilgrastim products and biosimilars across the Health Plan.

Policy Summary

Payermhn

PolicyPegfilgrastim and Biosimilars clinical policy

Policy CodePolicy Cp.Phar.296

Change TypeRedirections, HCPCS coding, indication updates

Effective Date12.01.16

Next Review Date

Key ActionFor mobilization prior to autologous transplantation, the pegfilgrastim product must be prescribed in combination with Mozobil per NCCN Compendium.

SourceLink

POLICY UPDATE CHANGES

Requirement for mobilization prior to autologous transplantation to be prescribed in combination with Mozobil per NCCN Compendium was added.

HCPCS codes Q5127, Q5130, J1449, and J9361 were added; J3590 removed.

Added Stimufend and Ziextenzo indications for hematopoietic subsyndrome of acute radiation syndrome and added Ryzneuta FDA approval.

Redirection/preferred biosimilar list updated multiple times (Udenyca redirection clarified to include all formulations; Nyvepria co-preference added then replaced by Fulphila).

New biosimilar Armlupeg added and Medicaid/HIM approval durations revised to 12 months; step therapy bypass for IL HIM added.

Appendix E state additions and exceptions (Mississippi, Tennessee exception, Indiana added).

4Recently added HCPCS/J-codes

1Removed HCPCS codes

3Biosimilar/formulary updates

3States added to Appendix E

Coverage Summary

This clinical policy (CP.PHAR.296) governs coverage for pegfilgrastim and its biosimilars and includes FDA-approved indications (e.g., prevention of febrile neutropenia and hematopoietic subsyndrome of acute radiation syndrome) and selected NCCN-supported off‑label uses. Coverage stance is mixed: coverage is available when policy criteria and formulary redirection rules are met, and certain off‑label uses are supported per NCCN compendium (for example, mobilization prior to autologous transplantation when used in combination with Mozobil). Effective date is listed in the policy header as 12.01.16 and the policy was last reviewed on 02.26.

Policy metadata

Policy numberCp.Phar.296

Payermhn

SubjectPegfilgrastim and Biosimilars clinical policy

StatusMODIFIED

Last review2026-03-26

Has material changetrue

Line(s) of businessCommercial, HIM, Medicaid

Approval durations (summary)Medicaid/HIM 12 months; Commercial 6 months (or to member renewal)

Medical Necessity and Indication-specific Criteria

Coverage and Redirection Requirements / Indication-specific Requirements

Policy updated with redirections, FDA indication additions, and NCCN-supported off-label language; coverage contingent on indication and redirection rules.

ALL of the following

Mobilization prior to autologous transplantation: For mobilization of peripheral-blood progenitor cells prior to autologous transplantation, product must be prescribed in combination with Mozobil per NCCN Compendium.
Prior requirement added 3Q2023 (see revision history).
Acute radiation syndrome (hematopoietic subsyndrome): coverage includes Stimufend and Ziextenzo indications; off-label use for Rolvedon and Ryzneuta is supported per NCCN compendium with standard off-label dosing language (two 6 mg doses one week apart for pegfilgrastim products; prescriber must submit supporting evidence for other agents).
FDA approvals and RT4 updates reflected in policy history.

Coding (HCPCS / Product Redirections)

Added HCPCS codes (recent revisions)HCPCS

Q5127	Stimufend (added 3Q2023)
Q5130	Fylnetra (added 3Q2023; later RT4 additions for acute radiation indication)
J1449	Rolvedon (added 3Q2023)
J9361	Efbemalenograstim alfa-vuxw (J9361 added 06.05.24)

Removed HCPCS codesHCPCSNot Covered

J3590

Removed (3Q2023)

Product redirections / preferred biosimilars (formulary preference)mixedCovered

Udenyca	Preferred redirect target for Neulasta OnPro, Rolvedon, Ryzneuta where applicable; redirection clarified to include all formulations (prefilled syringe, autoinjector, on-body injector).
Nyvepria	Was co-preferred with Udenyca (added June 2024), later replaced by Fulphila per December SDC (12.04.25).
Fulphila	Replaced Nyvepria as preferred biosimilar per December SDC (12.04.25).
Armlupeg	New biosimilar added RT4 (03.11.26); included in formulary and redirection rules.

Actions for Providers and Billing

Documentation Required

Prescribe combination with Mozobil for PBPC mobilization

For mobilization prior to autologous transplantation, the pegfilgrastim product must be prescribed in combination with Mozobil per NCCN Compendium.

Documentation Required

Follow NCCN compendium for acute radiation syndrome off-label dosing

For Rolvedon and Ryzneuta use in acute radiation syndrome, follow NCCN-supported off-label dosing language documented in the request.

Background and Definitions

This policy provides medical necessity guidance for pegfilgrastim (Neulasta/Neulasta Onpro) and multiple biosimilars (including Armlupeg, Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca formulations, Ziextenzo, Rolvedon, and Ryzneuta). It specifies FDA-approved indications (e.g., reduction in incidence of febrile neutropenia and, for select products, hematopoietic subsyndrome of acute radiation syndrome) and documents NCCN-supported off‑label uses (such as mobilization of peripheral‑blood progenitor cells prior to autologous transplantation in combination with plerixafor/Mozobil).

Formulary redirection and coding have been updated over time as new biosimilars and indications emerged: HCPCS codes Q5127 and Q5130 and J1449 were added in 3Q2023 and J9361 was added 06.05.24 while J3590 was removed; redirection/preferred biosimilar lists (e.g., redirection to Udenyca, co-preference changes among Nyvepria, Fulphila, and others) have been revised multiple times per the policy revision history. The policy also notes state‑specific Appendix E exceptions and additions that affect redirection rules.

Definitions

Revision History

04.14.23material_change

Added requirement that mobilization prior to autologous transplantation must be prescribed in combination with Mozobil per NCCN Compendium; added HCPCS codes Q5127 (Stimufend), Q5130 (Fylnetra), and J1449 (Rolvedon); removed HCPCS code J3590.

3Q2023coding_update

HCPCS codes Q5127 and Q5130 added (Stimufend and Fylnetra); J3590 removed; mobilization requirement with Mozobil added.

06.05.24coding_update

Added HCPCS code J9361 and added Mississippi to Appendix E.

Policy Summary

Payermhn

PolicyPegfilgrastim and Biosimilars clinical policy

Policy CodePolicy Cp.Phar.296

Change TypeRedirections, HCPCS coding, indication updates

Effective Date12.01.16

Next Review Date

Key ActionFor mobilization prior to autologous transplantation, the pegfilgrastim product must be prescribed in combination with Mozobil per NCCN Compendium.

SourceLink

On This Page

Redirection / formulary preference:

Redirection (formulary preference) rules apply: members must generally use Fulphila and Udenyca (or follow specified biosimilar step-through requirements) and requests may be redirected to preferred biosimilars (Udenyca and co-preferred agents such as Nyvepria then Fulphila per revision history); HCPCS coding updates (Q5127, Q5130, J1449, J9361 added; J3590 removed) apply per coding appendix.

Redirection preferences revised over time per revision log; prior authorization may be required for Fulphila and Udenyca.

Formulation-specific exclusions/clarifications: Certain product formulations have specific exclusions for acute radiation syndrome (e.g., 'Request is not for Neulasta Onpro or Udenyca Onbody' was added in revisions) and later clarification states redirection to Udenyca refers to all formulations (prefilled syringe, autoinjector, on-body injector); Udenyca refers to all formulations in multiple sections.

Policy history documents changes and clarifications regarding Udenyca formulations and Onbody use.

State-specific exceptions and Appendix E updates apply (e.g., added Mississippi, Tennessee exception language, and Indiana); states with regulations against redirections in cancer are listed in Appendix E and may override step therapy/redirection requirements.

When state Medicaid provisions conflict with policy, state provisions take precedence.

Billing Rule

Report HCPCS codes added/removed as per appendices

Use the HCPCS codes added to policy (Q5127, Q5130, J1449, J9361) and avoid using removed codes (J3590) per policy appendices and effective plan edits.

Affected codes: Q5127, Q5130, J1449, J9361; Removed code: J3590
See policy appendices and coding implications for effective plan edits and dates

Prior Authorization

Redirection to preferred biosimilars

Requests may be redirected to preferred biosimilars (Udenyca, Fulphila, Armlupeg when applicable) per plan formulary; providers should expect redirection and document medical necessity if requesting non-preferred product.

When requesting a non-preferred product, document medical necessity to support a request for the non-preferred agent

Documentation Required

State-specific exceptions

Observe Appendix E state-specific listings and exceptions (Mississippi, Tennessee exception, Indiana added) when requesting coverage; state Medicaid provisions take precedence when conflicting.

See Appendix E entries for Mississippi, Tennessee (noted exception), and Indiana

Prior Authorization

Approval duration change for Medicaid/HIM

Medicaid/HIM approval durations revised to 12 months (RT4 03.11.26); implementers must apply 12-month approval durations where applicable.

Medicaid/HIM approval duration: 12 months
RT4 change date noted 03.11.26

Step Therapy

Step therapy bypass for IL HIM

Added step therapy bypass for IL HIM per IL HB 5395 (RT4 03.11.26); implementers must apply this bypass.

Illinois HIM: step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (step therapy bypass)
RT4 change date noted 03.11.26

06.06.24formulary_change

Per June SDC, removed redirection to Zarxio and Ziextenzo and added redirection to Nyvepria to co-prefer with Udenyca and Nyvepria.

10.23.23indication_update

RT4: Stimufend added indication for hematopoietic subsyndrome of acute radiation syndrome; Ryzneuta (Ryzneuta) added; off-label support for Rolvedon and Ryzneuta aligned with NCCN compendium and standard off-label dosing language added; redirection to Udenyca for Neulasta OnPro, Rolvedon, and Ryzneuta where applicable.

03.12.24clarification

Clarified that redirection to Udenyca refers to all formulations (prefilled syringe, autoinjector, and on-body injector); Ziextenzo added acute radiation syndrome indication.

04.14.25indication_update

3Q2025 RT4: Fylnetra added to acute exposure to myelosuppressive doses of radiation indication per updated prescribing information; Appendix E revised with Tennessee exception language.

12.04.25formulary_change

Per December SDC, Nyvepria was replaced with Fulphila as a preferred biosimilar.

03.11.26material_changeLatest

RT4: Added new biosimilar Armlupeg to the policy; revised all Medicaid/HIM approval durations to 12 months; added step therapy bypass for Illinois HIM per IL HB 5395.

03.26.26appendix_updateLatest

Appendix E updated to add state Indiana.