CurrentEmblemHealthPolicy MG.MM.PH.61

Medical Policy: Colony Stimulating Factors: Fulphila ™ (pegfilgrastim-jmdb)

Defines medical necessity criteria, dosing, authorization length, preferred agents and step therapy requirements, applicable codes and diagnoses for Fulphila (pegfilgrastim-jmdb) across Commercial, Medicaid, and Medicare members for prevention/treatment of neutropenia and related indications.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Colony Stimulating Factors: Fulphila ™ (pegfilgrastim-jmdb)

Policy CodePolicy MG.MM.PH.61

Change TypeCriteria revision; step therapy; dosing update; authorization length extended

Effective DateMar 18, 2025

Next Review DateN/A

Key ActionTreating physician must submit clinical evidence demonstrating member meets criteria for treatment; without documentation EmblemHealth will not properly review preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

Updated risk factors (patient comorbidities) for febrile neutropenia and added criterion allowing use when expected febrile neutropenia incidence is <10% with two or more patient-related risk factors.

Updated dosing chart on 3/21/2024.

Extended coverage duration from 4 to 6 months (effective 1/1/2021).

Added Step therapy requiring trial of Neulasta AND Udenyca prior to Fulphila (noted 11/2/2020 and earlier updates).

6 monthsLength of Authorization

12Max billable units per dose period

Q5108

Coverage Summary

Defines medical necessity criteria, dosing, authorization length, preferred agents and step therapy requirements for Fulphila (pegfilgrastim-jmdb) across Commercial, Medicaid, and Medicare members. Coverage stance: covered_with_criteria. Effective date: 2025-03-18.

Policy-level key values

Length of Authorization6 months

Max billable units per dose period12 units

Primary HCPCS codeQ5108

Primary NDC67457-0833-06

G-CSF dosing intervalDo not dose more frequently than every 14 days

Acute radiation dosing6 mg subcutaneously weekly for 2 doses

Initial, Renewal, and Dosing Criteria

Initial Approval Criteria

Fulphila may be considered medically necessary if ONE of the following is met AND use is consistent with the medical necessity criteria that follows:

ANY of the following

Step therapy / established therapy / access / prolonged use / dose-dense regimens
- Step therapy: The patient has failed treatment with Neulasta AND Udenyca or they are contraindicated
  Commercial, Medicaid, AND Medicare members are subject to this step therapy
- Continuation of therapy: The patient is continuing previously established therapy with Fulphila for their current chemotherapy regimen
- Home health access:

Provider Actions & Billing

Prior Authorization

Submit clinical evidence for medical necessity

Treating physician must submit clinical evidence demonstrating member meets criteria for treatment; without documentation EmblemHealth will not properly review preauthorization or post-payment review.

Clinical evidence that member meets treatment criteria must be submitted to EmblemHealth or ConnectiCare
Failure to provide documentation will prevent proper preauthorization or post-payment review

Step Therapy

Step therapy requirement

Member must fail treatment with Neulasta AND Udenyca prior to Fulphila; applies to Commercial, Medicaid, AND Medicare members.

This step therapy requirement applies to Commercial, Medicaid, and Medicare members

Applicable Codes & Diagnoses

Applicable HCPCSHCPCSCovered

Q5108

Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5 mg

Applicable NDCsNDCCovered

67457-0833-06

Fulphila 6 mg prefilled syringe

Applicable ICD-10 Diagnoses (listed)ICD-10

D70.1	Agranulocytosis secondary to cancer chemotherapy
D70.9	Neutropenia, unspecified
T45.1X5A	Adverse effect of antineoplastic and immunosuppressive drugs initial encounter
T45.1X5D	Adverse effect of antineoplastic and immunosuppressive drugs subsequent encounter
T45.1X5S	Adverse effect of antineoplastic and immunosuppressive drugs sequela
Z41.8	Encounter for other procedures for purposes other than remedying health state
Z48.290	Encounter for aftercare following bone marrow transplant
Z51.11	Encounter for antineoplastic chemotherapy
Z51.12	Encounter for antineoplastic immunotherapy
Z51.89	Encounter for other specified aftercare

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Background, Evidence & Definitions

Fulphila is a pegylated filgrastim biosimilar colony stimulating factor that stimulates hematopoietic cell proliferation and activation. Policy criteria are based on clinical literature, regulatory status, and guidelines such as the NCCN Hematopoietic Growth Factors guideline. Neulasta and Udenyca are identified as the preferred agents, and a step therapy requires trial of Neulasta AND Udenyca prior to Fulphila for Commercial, Medicaid, and Medicare members unless contraindicated. Pegylated filgrastim is the G-CSF used in published trials for the listed dose-dense regimens.

Evidence source	Reference
Manufacturer package insert	Fulphila [package insert], Mylan GmbH, May 2019
Guideline reference	NCCN Hematopoietic Growth Factors Clinical Practice Guideline (expected febrile neutropenia incidence references)

Definitions:

- Febrile neutropenia: Temperature: a single temp ≥38.3 °C orally or ≥38.0 °C over 1 hour; AND neutropenia: <500 neutrophils/mcL or <1,000 neutrophils/mcL with predicted decline to ≤500 within 48 hours.

- Patient-related risk factors for febrile neutropenia include: Age >65 years receiving full dose intensity chemotherapy; prior exposure to chemotherapy or radiation therapy; persistent neutropenia (ANC ≤1000/mm3); bone marrow involvement by tumor; conditions increasing infection risk (e.g., HIV/AIDS with low CD4 counts); recent surgery/open wounds; poor performance status; renal dysfunction (creatinine clearance <50 mL/min); liver dysfunction (bilirubin >2.0 mg/dL); chronic immunosuppression post-transplant.

Revision History

11/2/2020step_therapy_addition

Added step therapy requiring trial of Neulasta AND Udenyca prior to Fulphila; noted effective 01/01/2021 and applied to Medicare, Commercial, and Medicaid members.

01/01/2021coverage_duration_extension

Extended coverage duration from 4 months to 6 months (Length of Authorization now 6 months).

03/21/2024dosing_chart_update

Updated dosing chart (annual review) — dosing/administration guidance for acute radiation exposure and other indications clarified.