CurrentCignaPolicy IP0070

Pegfilgrastim products (Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo)

Defines medical necessity, dosing, non-covered product exceptions by plan type, reauthorization, authorization durations, coding, and clinical background for pegfilgrastim products across Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyPegfilgrastim products (Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo)

Policy CodePolicy IP0070

Change TypeClarified (No criteria changes)

Effective DateDec 15, 2024

Next Review Date

Key ActionRequests for pegfilgrastim products require documentation that medical necessity criteria are met and plan-specific Non-Covered Product Criteria are satisfied (e.g., trial and intolerance to preferred alternatives or single-dose exception).

POLICY UPDATE CHANGES

Selected Revision states No criteria changes on 12/15/2024.

3Covered Indications (major categories)

12 monthsInitial Authorization Duration

12 monthsReauthorization Duration

MDSNot Covered Example Condition

Coverage Summary

Covered with criteria: pegfilgrastim products (Fulphila, Fylnetra, Neulasta, Nyvepria, Stimufend, Udenyca, Ziextenzo) are considered medically necessary when one of the specified indications is met — treatment during myelosuppressive chemotherapy for non-myeloid malignancy at increased risk of febrile neutropenia; treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (H-ARS) after exposure > 2 gray (Gy); or supportive care for peripheral blood progenitor cell transplantation — and plan-specific Non-Covered Product Criteria are satisfied. Dosing limits and authorization durations apply as specified in policy.

Initial Therapy Criteria

Dosing

Permitted dosing regimens

ANY of the following

Adults: 6 mg by subcutaneous injection one time6 mg, subcutaneous
For chemotherapy indication: no more frequently than once every 2 weeks; for radiation syndrome: no more frequently than 1 week apart
Children: Up to 200 mcg/kg by subcutaneous injection<= 200 mcg/kg, subcutaneous

Continuation Therapy Criteria

Reauthorization / Continuation Criteria

Continuation is medically necessary when:

ALL of the following

Above medical necessity criteria are met
Documentation of beneficial response

Non‑Covered Product Criteria by Plan Type

Non-Covered Product Criteria: Plan-specific requirements that must be met for non-preferred pegfilgrastim products (for example, Employer Group, Cigna Total Savings, Individual & Family drug lists). Typically requires documentation of ONE of the following per the applicable plan: a trial of and inability to continue preferred alternative(s) due to a formulation difference in inactive ingredient(s) causing significant allergy or serious adverse reaction to all listed alternatives, or a documented need for a single dose to complete the current chemotherapy cycle with a plan to switch to a preferred pegfilgrastim product for subsequent cycles. Operationally, confirm the applicable drug list and submit required documentation per plan rules.

Applicable Codes

Procedure Codes (Covered when medically necessary)CPTCovered

96372	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
96377	Application of on-body injector (includes cannula insertion) for timed subcutaneous injection

Drug/J-codes and Q-codes (Covered when medically necessary)mixedCovered

J2506	Injection, pegfilgrastim, excludes biosimilar, 0.5 mg
Q5108	Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5 mg
Q5111	Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5 mg
Q5120	Injection, pegfilgrastim-bmez, biosimilar, (Ziextenzo), 0.5 mg
Q5122	Injection, pegfilgrastim-apgf, biosimilar, (Nyvepria), 0.5 mg
Q5127	Injection, pegfilgrastim-fpgk (Stimufend), biosimilar, 0.5 mg (Code effective 04/01/2023)
Q5130	Injection, pegfilgrastim-pbbk (Fylnetra), biosimilar, 0.5 mg (Code effective 04/01/2023)

Provider Actions

Prior Authorization

Medical necessity review required

Requests for pegfilgrastim products require documentation that medical necessity criteria are met and that plan-specific Non-Covered Product Criteria are satisfied (e.g., trial and intolerance to preferred alternatives or a single‑dose exception).

J2506
Q5108
Q5111
Q5120
Q5122
Q5127
Q5130
Document medical necessity and plan-specific Non‑Covered Product Criteria (trial/intolerance to preferred alternatives or single‑dose exception)

Documentation Required

Documentation of beneficial response for reauthorization

For continuation (reauthorization) requests, submit documentation demonstrating a beneficial response to pegfilgrastim to support ongoing coverage.

Billing Rule

Dosing frequency limits

Do not administer pegfilgrastim more frequently than specified by indication: for chemotherapy prophylaxis, dosing up to 6 mg subcutaneously no more frequently than once every 2 weeks; for treatment of Radiation Syndrome (H‑ARS), dosing up to 6 mg subcutaneously no more frequently than 1 week apart.

Clinical Evidence

Evidence notes: The NCCN Hematopoietic Growth Factors guideline (version 3.2024) recommends pegfilgrastim for prophylactic use when the patient is receiving anti-cancer therapy associated with a high (>20%) risk of febrile neutropenia and recommends considering CSF therapy for patients with an intermediate (10%–20%) risk based on individual factors. NCCN guidance also recognizes FDA‑approved biosimilars as appropriate substitutes and includes pegfilgrastim recommendations for hematopoietic cell mobilization in transplant settings.

Background

Background: Pegfilgrastim, a granulocyte colony stimulating factor (G-CSF), is indicated to decrease febrile neutropenia incidence in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy and to increase survival after acute high-dose radiation exposure (H-ARS). Multiple biosimilars to Neulasta (Fulphila, Fylnetra, Nyvepria, Stimufend, Udenyca, Ziextenzo) are available; product labeling differs — only Neulasta, Stimufend, Udenyca, and Ziextenzo include the H-ARS indication — and dosing guidance includes adult 6 mg subcutaneous and pediatric up to 200 mcg/kg subcutaneous regimens.