CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Filgrastim products (Neupogen and biosimilars) for prevention and treatment of neutropenia/febrile neutropenia

Defines coverage and prior-authorization criteria for Neupogen and filgrastim biosimilars (Nivestym, Granix, Zarxio, Releuko) for FDA-approved and compendial indications including primary/secondary prophylaxis of febrile neutropenia, treatment of febrile neutropenia, stem cell mobilization, severe chronic neutropenia, myelodysplastic syndromes, hematopoietic syndrome of acute radiation syndrome, and other listed supportive care indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilgrastim products (Neupogen and biosimilars) for prevention and treatment of neutropenia/febrile neutropenia

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must submit prior authorization documentation including diagnosis and current/planned chemotherapeutic regimen and, for intermediate-risk regimens, documentation of patient-specific risk factors demonstrating high risk.

POLICY UPDATE CHANGES

No material clinical or coverage changes were made to this policy.

MultipleCovered Indications

6 monthsAuth duration (typical)

>=20% or 10-19%+risk factorsFN prophylaxis thresholds

Coverage summary

This policy defines coverage and prior-authorization criteria for filgrastim products (Neupogen) and biosimilars (Nivestym, Granix, Zarxio, Releuko) for FDA-approved and compendial indications. Covered indications include: primary and secondary prophylaxis of febrile neutropenia and treatment of febrile neutropenia in patients receiving myelosuppressive chemotherapy; reduction of duration of neutropenia in acute myeloid leukemia induction/consolidation and in patients undergoing bone marrow/stem cell transplantation; mobilization of peripheral blood progenitor cells for collection; management of severe chronic neutropenia (congenital, cyclic, idiopathic); treatment of neutropenia in myelodysplastic syndromes (MDS); hematopoietic syndrome of acute radiation syndrome; and other supportive care indications listed in compendia. Coverage stance: covered with criteria with typical authorization durations of up to 6 months when policy criteria are met.

Provider actions & prior authorization

Prior Authorization

Prior authorization required

Authorization of up to 6 months may be granted when criteria are met; providers must submit documentation of diagnosis and current/planned chemotherapeutic regimen and, for intermediate-risk regimens (10-19% FN), documentation of patient-specific risk factors demonstrating high risk.

Documentation Required

Documentation requirements

Documentation must be provided of the member's diagnosis and chemotherapeutic regimen; for intermediate-risk regimens provide patient risk factor documentation; for secondary prophylaxis provide documentation of prior FN or dose-limiting neutropenic event with same chemo dose/schedule.

Denial Risk

Exclusion for experimental indications

All other indications not listed (outside FDA-approved and compendial uses enumerated) are considered experimental/investigational and not medically necessary and may be denied.

Clinical evidence & references

Filgrastim (Neupogen) and filgrastim biosimilars are granulocyte colony-stimulating factors indicated to decrease the incidence of infection as manifested by febrile neutropenia in patients receiving myelosuppressive chemotherapy, to reduce the duration of neutropenia in acute myeloid leukemia induction/consolidation and in bone marrow transplant settings, to mobilize hematopoietic progenitor cells for collection, and for chronic severe neutropenias and radiation-exposure indications. The policy references FDA package inserts for Neupogen and biosimilars and authoritative guidance sources including the NCCN guidelines, ASCO guidance, and drug compendia.

References: Neupogen, Nivestym, Granix, Releuko, Zarxio package inserts; NCCN; ASCO 2015 guideline; DRUGDEX; Lexicomp.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFilgrastim products (Neupogen and biosimilars) for prevention and treatment of neutropenia/febrile neutropenia

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Filgrastim products (Neupogen and biosimilars) for prevention and treatment of neutropenia/febrile neutropenia

Coverage summary

Authorization for prevention or treatment of febrile neutropenia

Other covered indications (authorization of 6 months)

Continuation of therapy

Unproven / exclusions

Applicable codes (NDC products)

Provider actions & prior authorization

Clinical evidence & references

Definitions

Revision history

Neupogen	Filgrastim (brand) - FDA-approved indications listed
Nivestym	Filgrastim-aafi biosimilar
Granix	Tbo-filgrastim
Zarxio	Filgrastim-sndz biosimilar
Releuko	Filgrastim-ayow biosimilar