MHN pegfilgrastim coverage Prior Auth & Update

Coverage Criteria

I.A. Initial Approval — Chemotherapy-Induced Neutropenia

Covered when ALL of the following are met:

Diagnosis and use: 1. Diagnosis of non-myeloid malignancy (i.e., solid tumor or lymphoid malignancy); 2. Prescribed for use following myelosuppressive chemotherapy;

Agent-specific sequencing: 3. One of the following (a or b): a. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings (see Appendix E); OR b. One of the following (i, ii, or iii): i. Request is for Fulphila or Udenyca (Udenyca refers to all formulations); ii. If request is for a biosimilar pegfilgrastim product other than Fulphila or Udenyca (e.g., Fylnetra, Nyvepria, Ziextenzo, Stimufend), member must have used both Fulphila and Udenyca unless contraindicated or clinically significant adverse effects occur; iii. If request is for Neulasta, Neulasta Onpro, Rolvedon, or Ryzneuta, member must use Fulphila and Udenyca unless contraindicated/adverse effects, and if unable to use those, must use biosimilar pegfilgrastim products unless contraindicated/adverse effects.

Prior authorization may be required for Fulphila and Udenyca

Timing between dose and next chemo: For pegfilgrastim: confirm at least 12 days between dose and the next cycle of chemotherapy; For eflapegrastim-xnst or efbemalenograstim alfa-vuxw: confirm at least 14 days between dose and the next cycle of chemotherapy.pegfilgrastim >=12 days; eflapegrastim/efbemalenograstim >=14 days

Udenyca refers to all formulations

Concurrent therapy: Requested medication will not be prescribed concurrently with other colony stimulating factors (e.g., filgrastim, Leukine) within any chemotherapy cycle;

Palliative care consideration: For members receiving palliative chemotherapy, provider attestation that chemotherapy dose reduction has been considered.

Dose limits: Dose does not exceed one of the following: a) pegfilgrastim 6 mg (1 syringe) per chemotherapy cycle; b) eflapegrastim-xnst 13.2 mg (1 syringe) per chemotherapy cycle; c) efbemalenograstim alfa-vuxw 20 mg (1 syringe) per chemotherapy cycle.see dose limits

I.B. Acute Radiation Syndrome

Covered when ALL of the following are met:

Exposure: 1. Prescribed for use following suspected or confirmed acute exposure to myelosuppressive doses of radiation;

Device exclusions: 2. Request is not for Neulasta Onpro or Udenyca Onbody;

Dose: 3. Dose: for pegfilgrastim—two 6 mg doses administered subcutaneously one week apart; for eflapegrastim-xnst or efbemalenograstim alfa-vuxw—dose must be supported by practice guidelines or peer-reviewed literature and prescriber must submit supporting evidence.pegfilgrastim two 6 mg doses one week apart

Administer first dose as soon as possible and the second dose one week later

I.C. Bone Marrow Transplantation (mobilization) — off-label

Covered when ALL of the following are met:

Indication: 1. Prescribed for mobilization of peripheral‑blood progenitor cells prior to autologous transplantation;

Product exclusions: 2. Request is not for Rolvedon or Ryzneuta;

Combination therapy: 3. Prescribed in combination with plerixafor (Mozobil) as specified;

Prior authorization may be required for Leukine

Sequencing: 4. One of the following: a. Request is for treatment associated with cancer for a State with regulations against step therapy; OR b. Failure of Leukine unless contraindicated or clinically significant adverse effects experienced, AND agent sequencing per policy (use of Fulphila and Udenyca or required biosimilars as described for other indications).

I.D. Wilms Tumor — off-label supportive care

Covered when ALL of the following are met:

Diagnosis: 1. Diagnosis of Wilms tumor (nephroblastoma);

Product exclusions: 2. Request is not for Rolvedon or Ryzneuta;

Regimen: 3. Request is for supportive care for a member receiving a regimen of cyclophosphamide + etoposide, or cyclophosphamide + doxorubicin + vincristine (Regimen M and Regimen I; see Appendix D);

Sequencing: 4. One of the following: a. Request is for treatment associated with cancer for a State with regulations against step therapy; OR b. One of: i. Request is for Fulphila or Udenyca; ii. If request is for a biosimilar pegfilgrastim product other than Fulphila or Udenyca, member must use Fulphila and Udenyca unless contraindicated or clinically significant adverse effects; iii. If request is for Neulasta or Neulasta Onpro, member must use Fulphila and Udenyca unless contraindicated/adverse effects, and if unable to use those, must use biosimilar pegfilgrastim products unless contraindicated/adverse effects.

I.E. Other diagnoses/indications

Covered when the following are met:

Cancer-associated or formulary pathway: 1. One of the following: a. Request is for treatment associated with cancer for a State with regulations against step therapy in certain oncology settings; OR b. Sequencing per policy: requests for biosimilar pegfilgrastim products other than Fulphila or Udenyca require prior use of Fulphila and Udenyca unless contraindicated or intolerable; requests for Neulasta/Neulasta Onpro/Rolvedon/Ryzneuta require prior use of Fulphila and Udenyca (then other biosimilars if unable to use those).

Prior authorization may be required for Fulphila and Udenyca

Formulary/label changes: 2. If the drug recently (within the last 6 months) underwent a label change not yet reflected in this policy, refer to the appropriate formulary/off‑label policies for the relevant line of business (see policy references listed in the policy).

References: CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16; CP.CPA.09; HIM.PA.154; CP.PMN.53

II. Continued Therapy (All Indications)

Covered when ALL of the following are met:

Continuation eligibility: 1. Member meets one of the following: a. Currently receiving medication via Centene benefit or previously met initial approval criteria; OR b. Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Response: 2. Member is responding positively to therapy;

Sequencing: 3. One of the following: a. Request is for treatment associated with cancer for a State with regulations against step therapy; OR b. One of: i. Request is for Fulphila or Udenyca; ii. If request is for a biosimilar pegfilgrastim product other than Fulphila or Udenyca, member must have used Fulphila and Udenyca unless contraindicated or intolerable; iii. If request is for Neulasta, Neulasta Onpro, Rolvedon, or Ryzneuta, member must have used Fulphila and Udenyca unless contraindicated/adverse effects, and if unable to use those, must use biosimilar pegfilgrastim products.

Prior authorization may be required for Fulphila and Udenyca

Continuation and alternative‑biosimilar sequencing

Dosing criteria by product/indication (constraints that apply to continuation and alternative biosimilar sequencing)

Concurrent therapy restriction: Requested medication will not be prescribed concurrently with other colony stimulating factors within any chemotherapy cycle;

Chunk 18

Dose increase maximums: If requesting a dose increase, new dose must not exceed indication‑specific maximums: chemotherapy‑induced neutropenia—pegfilgrastim 6 mg per cycle; eflapegrastim 13.2 mg per cycle; efbemalenograstim alfa‑vuxw 20 mg per cycle; acute radiation—pegfilgrastim two 6 mg doses one week apart; bone marrow transplantation—6 mg per dose; Wilms tumor—6 mg once per chemotherapy cycle.see children

Chunks 18 and 19

Biosimilar sequencing for other indications: Requests for Fulphila or Udenyca may be subject to state regulations against step therapy; for biosimilar pegfilgrastim products other than Fulphila or Udenyca, member must use Fulphila and Udenyca unless contraindicated or intolerable. For Neulasta/Neulasta Onpro/Rolvedon/Ryzneuta, member must use Fulphila and Udenyca, then other biosimilars if unable to use those two.

The following products are not indicated for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation: Neulasta, Fulphila, Fylnetra, Nyvepria, Rolvedon, Ryzneuta, Stimufend, Udenyca (including autoinjector/Onbody formulations), and Ziextenzo. Requests for mobilization using these agents should be evaluated under the off‑label mobilization criteria in this policy (see Bone Marrow Transplantation/mobilization section) and must meet the specified combination and sequencing requirements when coverage is considered.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid).

The policy no longer includes coverage for off‑label use of colony‑stimulating factors for supportive care post autologous hematopoietic cell transplantation, as this use was removed when it was no longer supported by the NCCN Compendium. Requests for this scenario will not be authorized under the prior supportive‑care language in this policy.

Use of colony‑stimulating factors (CSFs) solely to maintain chemotherapy dose‑intensity in metastatic disease is not generally supported. The available evidence has not demonstrated improvements in disease‑free or overall survival with CSFs for this purpose; dose reduction or delay remains an appropriate strategy in palliative settings unless individual clinical circumstances justify CSF use.

Initial Therapy

Initial approval criteria for chemotherapy-induced neutropenia

Initial criteria: Diagnosis of non‑myeloid malignancy; prescribed following myelosuppressive chemotherapy; sequencing requirements (Fulphila and Udenyca preference or applicable state exception); confirmation of timing between dose and next chemotherapy per agent; not prescribed concurrently with other CSFs; palliative care considerations; dose limits as specified.

Initial biosimilar sequencing

Biosimilar sequencing for initial therapy requests

Initial biosimilar requirement: Requests for biosimilar pegfilgrastim products other than Fulphila or Udenyca require prior use of Fulphila and Udenyca unless contraindicated or clinically significant adverse effects are experienced; requests for Neulasta/Neulasta Onpro/Rolvedon/Ryzneuta similarly require trial of Fulphila and Udenyca (then other biosimilars if unable to use those).sequence

Continued Therapy / Approval Duration

Continued Therapy

Continued therapy requirements

Eligibility: Member currently receiving medication via Centene benefit or previously met initial approval criteria; OR member is subject to continuity of care regulations; member is responding positively to therapy.

Sequencing: Continued therapy must follow the same step‑therapy sequencing as initial therapy (Fulphila/Udenyca preference unless state/regulation exception applies).

Prior authorization may be required for Fulphila and Udenyca

Concurrent therapy: Requested medication will not be prescribed concurrently with other colony stimulating factors within any chemotherapy cycle;

Dose increase constraints:

Step Therapy and Sequencing

Step	Requirement	Failure criteria / exceptions
1	Member must have used Fulphila and Udenyca prior to coverage of many other biosimilar or reference pegfilgrastim products for chemotherapy‑induced neutropenia (Fulphila or Udenyca requests are acceptable alternatives).	Exception for members in States with regulations prohibiting oncology step therapy (see Appendix E); clinical contraindication or clinically significant adverse effects to Fulphila and/or Udenyca also qualify as failure of step therapy.

Step	Requirement	Notes / state restrictions
1	Trial of Fulphila followed by Udenyca is required prior to coverage of other biosimilar pegfilgrastim products (e.g., Fylnetra, Nyvepria, Ziextenzo, Stimufend) unless contraindicated or intolerable.	If member resides in a State with prohibitions on step therapy/redirection for certain oncology indications, the sequencing requirement does not apply (see Appendix E for state list and notes). Prior authorization may be required for Fulphila and Udenyca.

Date / Update	Change	Implication for sequencing
Per February SDC (historical) / RT updates through 06.05.24 and 06.06.24	Udenyca was added as a step/co‑preferred agent (co‑preference/redirection rules updated over time; redirections to Ziextenzo were removed; Nyvepria was later co‑preferred with Udenyca and Fulphila became preferred per subsequent updates).	Policy sequencing evolved to include Udenyca as a required step/co‑preference alongside Fulphila; redirections and preferred biosimilar listings have been updated periodically and may affect which agent is required first for coverage determinations.

Quantity Limits and Dosing

inv-41: pegfilgrastim (all formulations) — 6 mg

ProductPegfilgrastim (all formulations)

Standard adult dose per chemotherapy cycle6 mg subcutaneous once per chemotherapy cycle (maximum 6 mg/dose)

Timing relative to chemotherapyDo not administer between 14 days before and 24 hours after cytotoxic chemotherapy; confirm ≥12 days between dose and next chemo for pegfilgrastim

inv-42: eflapegrastim-xnst — 13.2 mg

ProductEflapegrastim‑xnst (Rolvedon)

Standard adult dose per chemotherapy cycle13.2 mg subcutaneous once per chemotherapy cycle (maximum 13.2 mg/dose)

Coding

Referenced HCPCS/J codesHCPCS

J2506	Injection, pegfilgrastim, excludes biosimilar, 0.5 mg.
Q5111	Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5 mg.
Q5108	Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 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.
Q5130	Injection, pegfilgrastim-pbbk (Fylnetra), biosimilar, 0.5 mg.
J1449	Injection, eflapegrastim-xnst, 0.1 mg
J9361	Injection, efbemalenograstim alfa-vuxw, 0.5 mg

inv-14: Dose limits — pegfilgrastim 6 mg; eflapegrastim-xnst 13.2 mg; efbemalenograstim alfa-vuxw 20 mg

Pegfilgrastim dose limit6 mg per chemotherapy cycle (maximum 6 mg/dose)

Eflapegrastim‑xnst dose limit13.2 mg per chemotherapy cycle (maximum 13.2 mg/dose)

Efbemalenograstim alfa‑vuxw dose limit20 mg per chemotherapy cycle (maximum 20 mg/dose)

inv-15: Pediatric weight cutoff — < 45 kg for weight-based pediatric dosing and autoinjector not for use in pediatric patients < 45 kg

Pediatric weight cutoffWeight-based dosing applies for pediatric patients < 45 kg

Autoinjector limitationAutoinjector not for use in pediatric patients < 45 kg

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Coding Updates

Prior authorization is required for certain pegfilgrastim products and may be required or impacted by coding updates. Providers must obtain prior authorization when prescribing Fulphila, Udenyca, and other pegfilgrastim products as specified by the plan and submit claims using the most current HCPCS/J‑codes. Inclusion or exclusion of codes in this policy does not guarantee coverage; verify PA requirements and codes at time of submission.

Prior authorization may be required for Fulphila and Udenyca.
Policy updated to add HCPCS codes Q5127 (Stimufend), Q5130 (Fylnetra), J1449 (Rolvedon), J9361 (efbemalenograstim alfa-vuxw) and others — consult policy coding section.
Providers should reference up-to-date professional coding guidance prior to claim submission.

Step Therapy

Step Therapy Sequencing

Step therapy sequencing applies across initial and continued therapy: Fulphila and Udenyca are the preferred initial agents and must be used prior to other biosimilars or the reference product unless contraindicated or clinically significant adverse effects occur. State-specific exceptions (see Appendix E) may override step therapy in oncology settings.

Biosimilar Preferences and Redirections

Step Therapy

Fulphila (then Udenyca) preferred in sequencing

For sequencing requirements, members generally must use Fulphila followed by Udenyca before other pegfilgrastim products unless contraindicated or clinically significant adverse effects occur.

Step Therapy

Udenyca required with Fulphila in sequencing

Udenyca (all formulations) is required alongside Fulphila in the sequencing prior to other products unless contraindicated or clinically significant adverse effects occur.

Step Therapy

Trial of Fulphila then Udenyca required for many biosimilars

Many biosimilar pegfilgrastim requests require the member to have used Fulphila followed by Udenyca unless contraindicated or intolerable.

Site of Care and Formulations

Note

Product formulations and pediatric autoinjector limitation

Products are available as single‑dose prefilled syringes and some are co‑packaged with on‑body injectors or available as autoinjectors; the autoinjector is not for use in pediatric patients weighing <45 kg.

Prefilled syringe, on‑body injector co‑packaging, and autoinjector formulations are referenced
Autoinjector not for pediatric patients <45 kg

Note

Redirections and sequencing apply to all formulations

Policy references all formulations (prefilled syringe, autoinjector, on‑body injector) and notes that redirection and sequencing rules apply to all formulations where specified.

Background

Pegfilgrastim and its biosimilars are leukocyte growth factors indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy. Several listed products (for example, Neulasta, Fylnetra, Stimufend, Udenyca in specified formulations, and Ziextenzo) also have an indication to increase survival after acute high‑dose radiation exposure (hematopoietic subsyndrome of acute radiation syndrome).

Definitions

inv-30: Febrile neutropenia indication — Indicated to decrease incidence of infection as manifested by febrile neutropenia in patients receiving myelosuppressive chemo

Indication statementIndicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non‑myeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Applicable agentsPegfilgrastim (originator and biosimilars), eflapegrastim, efbemalenograstim

Clinical contextUsed as prophylaxis to reduce FN risk related to myelosuppressive chemotherapy regimens per guideline recommendations

inv-31: Neutropenia definition — ANC < 500 or ANC < 1,000 with predicted decline to ≤ 500 within 48 hours

Neutropenia definitionAbsolute neutrophil count (ANC) < 500 neutrophils/mcL or ANC < 1,000 neutrophils/mcL with predicted decline to ≤ 500 within 48 hours.

Quick Reference / Key Codes & Dosing

Referenced HCPCS/J codesHCPCS

J2506	Injection, pegfilgrastim, excludes biosimilar, 0.5 mg.
Q5111	Injection, pegfilgrastim-cbqv, biosimilar, (Udenyca), 0.5 mg.
Q5108	Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 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.
Q5130	Injection, pegfilgrastim-pbbk (Fylnetra), biosimilar, 0.5 mg.
J1449	Injection, eflapegrastim-xnst, 0.1 mg
J9361	Injection, efbemalenograstim alfa-vuxw, 0.5 mg

inv-14: Dose limits quick reference — pegfilgrastim 6 mg; eflapegrastim-xnst 13.2 mg; efbemalenograstim alfa-vuxw 20 mg

Pegfilgrastim dose limit (quick ref)6 mg per chemotherapy cycle (maximum 6 mg/dose)

Eflapegrastim‑xnst quick ref13.2 mg per chemotherapy cycle (maximum 13.2 mg/dose)

Efbemalenograstim alfa‑vuxw quick ref20 mg per chemotherapy cycle (maximum 20 mg/dose)

OpenPayer

Pegfilgrastim and Biosimilars (Neulasta, Fulphila, Udenyca, and others)

Coverage Criteria

Initial Therapy

Continued Therapy / Approval Duration

Step Therapy and Sequencing

Quantity Limits and Dosing

Coding

Provider Actions and Requirements

Biosimilar Preferences and Redirections

Site of Care and Formulations

Background

Definitions

Quick Reference / Key Codes & Dosing