CurrentNeighborhood Health Plan of Rhode IslandPolicy 1931-A

Pegfilgrastim (Neulasta and biosimilars) — Prevention and Treatment of Febrile Neutropenia

Covers pegfilgrastim and biosimilars (brand and generic) for prevention of chemotherapy-induced febrile neutropenia, stem cell transplant uses, and acute radiation syndrome when approval criteria are met for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPegfilgrastim (Neulasta and biosimilars) — Prevention and Treatment of Febrile Neutropenia

Policy CodePolicy 1931-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionRequest prior authorization with documentation of diagnosis, chemotherapeutic regimen, and patient risk factors when applicable; up to 6 months authorization may be granted if criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical authorization duration

>20%high-risk FN threshold

10-20%intermediate FN range

16tumor/regimen groups listed

Coverage Criteria for Pegfilgrastim and Biosimilars

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Prevention of Neutropenia / Prophylaxis criteria

Authorization for prevention of febrile neutropenia may be granted when ALL of the following are met:

General limits: Requested medication will not be used in combination with other colony stimulating factors within any chemotherapy cycle; the member will not receive chemotherapy at the same time as radiation therapy; the requested medication will not be administered with weekly chemotherapy regimens.

authorization up to 6 months

Primary prophylaxis indications (one required): One of: myelosuppressive anti-cancer therapy expected to result in >20% incidence of febrile neutropenia (Appendix A); therapy expected to result in 10–20% FN (Appendix B) AND the patient is high risk because of bone marrow compromise, comorbidities, or other patient-specific risk factors (Appendix C); therapy expected to result in <10% FN and the patient has at least 2 patient-related risk factors (Appendix C).FN risk thresholds per Appendices A–C

See documentation requirements: diagnosis, regimen, and risk-factor documentation for intermediate/low-risk regimens

Secondary prophylaxis: Use for secondary prophylaxis in members who experienced a febrile neutropenic complication or a dose-limiting neutropenic event from a prior cycle of similar chemotherapy at the same dose and schedule when primary prophylaxis was not received.

Other authorized indications: Stem cell transplantation-related indications; Hematopoietic Subsyndrome of Acute Radiation Syndrome; treatment for radiation-induced myelosuppression following a radiological/nuclear incident; hairy cell leukemia with neutropenic fever following chemotherapy.

Authorization of 6 months may be granted for these indications.

Coverage criteria overview

Covered when meeting indication-specific authorization rules and regimen risk considerations

Authorization for other indications: Authorization of 6 months may be granted for members with listed indications such as stem cell transplantation-related indications; hematopoietic subsyndrome of acute radiation syndrome; treatment for radiation-induced myelosuppression after a radiological/nuclear incident; hairy cell leukemia with neutropenic fever following chemotherapy.

See Appendix references

Continuation of therapy: All members requesting authorization for continuation must meet all requirements in the coverage criteria.

Continuation requirement

High-risk chemotherapy regimens (Appendix A): Use of prophylactic pegfilgrastim is supported for patients receiving chemotherapy regimens with an incidence of febrile neutropenia >20% as listed in Appendix A (examples include regimens for ALL, dose-dense breast cancer regimens, various lymphoma regimens, bone cancer regimens, etc.).>20% incidence

Regimens with intermediate FN risk

Regimens identified as having an intermediate (10%–20%) incidence of febrile neutropenia include the following (organized by tumor type):

Wilms Tumor regimens: Regimen M (vincristine, dactinomycin, doxorubicin, cyclophosphamide, etoposide); Regimen I (vincristine, doxorubicin, cyclophosphamide, etoposide); Revised Regimen UH-1 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide); Revised Regimen UH-2 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, irinotecan).10%-20%

Applies to regimens with or without monoclonal antibodies.

Occult primary - adenocarcinoma: Gemcitabine/docetaxel.

Breast cancer: Docetaxel ± trastuzumab; AC + sequential docetaxel (taxane portion only); AC + sequential docetaxel + trastuzumab; Paclitaxel every 21 days ± trastuzumab; Sacituzumab govitecan-hziy; TC (docetaxel, cyclophosphamide).

All other indications not explicitly listed in the policy’s approved uses (beyond the FDA indication and compendial uses such as stem cell transplantation-related indications, prophylaxis for chemotherapy‑induced febrile neutropenia in patients with solid tumors, hematopoietic acute radiation syndrome, and hairy cell leukemia with neutropenic fever) are considered experimental/investigational and not medically necessary.

The appendices provided in this policy are not comprehensive. Other chemotherapy agents or regimens beyond those listed may also have an intermediate or high incidence of febrile neutropenia and therefore are not explicitly enumerated in these lists.

The regimens listed in Appendix B (and other appendices) do not represent an exhaustive catalogue. Clinicians and reviewers should recognize that additional agents or regimens may carry intermediate or high risk for development of febrile neutropenia even if they are not named in the document.

Any indication outside of the policy’s listed FDA-approved uses and accepted compendial indications (for example, uses other than those described for stem cell transplant settings, chemotherapy prophylaxis, acute radiation syndrome, or hairy cell leukemia neutropenic fever) is considered experimental/investigational and not medically necessary for coverage purposes.

Risk Thresholds and Definitions

Febrile neutropenia risk thresholds

High-risk threshold>20% incidence of febrile neutropenia (primary prophylaxis indicated)

Intermediate-risk threshold10%–20% incidence of febrile neutropenia (consider prophylaxis if patient is high-risk)

Low-risk with patient factors<10% incidence but patient has ≥2 risk factors from Appendix C (prophylaxis may be indicated)

Febrile neutropenia incidence threshold

Defined incidence range10% to 20% incidence of febrile neutropenia

Appendix referenceSee Appendix B for selected regimens with 10%–20% FN incidence

List completenessAppendix B is not comprehensive; other agents/regimens may also have intermediate/high risk

Neulasta indication

Indication (pegfilgrastim)Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant FN incidence.

Product examplesNeulasta and biosimilars (pegfilgrastim products) referenced in policy and compendia

SettingUsed for patients receiving myelosuppressive chemotherapy associated with clinically significant FN incidence

Radiation syndrome indication

Radiation syndrome indicationIndicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Use caseTreatment following a radiological/nuclear incident for radiation-induced myelosuppression

Authorization noteAuthorization of up to 6 months may be granted for this indication when criteria are met

High-risk regimens

DefinitionChemotherapy regimens with an incidence of febrile neutropenia greater than 20% are considered high-risk (see Appendix A).

Appendix referenceSee Appendix A for selected high-risk regimens

List completenessAppendix A is not comprehensive; other agents/regimens may also have high risk

Intermediate-risk regimens

DefinitionChemotherapy regimens with an incidence of febrile neutropenia of 10% to 20% are considered intermediate-risk (see Appendix B).

Appendix referenceSee Appendix B for selected intermediate-risk regimens

Clinical implicationProphylactic G-CSF may be considered based on regimen risk plus patient-specific factors

Intermediate-risk regimen (definition)

Approximate incidenceAssociated with an approximate 10%–20% incidence of febrile neutropenia

Clinical considerationUse regimen- and patient-specific risk assessment to determine need for prophylactic growth factor support

Appendix guidanceRegimens listed in Appendix B illustrate this intermediate-risk category

Patient risk factors for febrile neutropenia

Examples of patient risk factorsActive infection, open wounds, or recent surgery

Age and bone marrow involvementAge ≥65 years; bone marrow involvement by tumor producing cytopenias

Other key risk factorsPrevious chemotherapy or radiation; poor nutritional status; poor performance status; prior FN; serious comorbidities (renal/liver dysfunction, HIV, cardiovascular disease); persistent neutropenia

Prior Authorization, Documentation, and Continuation Rules

Prior Authorization

Prior authorization — 6 month approvals

Authorization of up to 6 months may be granted when all coverage criteria are met. Documentation must include the member's diagnosis and the chemotherapeutic regimen. If the chemotherapeutic regimen has a low or intermediate risk of febrile neutropenia (≤20%), documentation must also outline the member's risk factors that confirm the member is at high risk for febrile neutropenia.

Authorization duration: up to 6 months when criteria are met
Do not combine with other colony stimulating factors within any chemotherapy cycle
Not to be administered concurrently with radiation therapy
Not to be administered with weekly chemotherapy regimens

Prior Authorization

6-month authorization for selected indications

Authorization of 6 months may be granted for the listed other indications when all coverage criteria are met.

Stem cell transplantation-related indications
Hematopoietic Subsyndrome of Acute Radiation Syndrome
Treatment for radiation-induced myelosuppression following a radiological/nuclear incident
Hairy cell leukemia with neutropenic fever following chemotherapy

Prior Authorization

PA for growth factor support

Prior authorization considerations may apply when requesting prophylactic hematopoietic growth factors for patients receiving listed myelosuppressive chemotherapy regimens. Use Appendix B for regimens with intermediate (10%–20%) FN risk and Appendix A for regimens with >20% FN risk to determine eligibility for primary prophylaxis.

Regimens with >20% FN risk: primary prophylaxis indicated (see Appendix A)
Regimens with 10–20% FN risk: primary prophylaxis may be indicated if patient has high-risk features (see Appendix B and Appendix C)
Regimens with <10% FN risk: primary prophylaxis considered only with ≥2 patient-related risk factors (see Appendix C)

Denial Risk

Combination use and excluded administration scenarios

The requested medication must not be used in combination with other colony stimulating factors within any chemotherapy cycle. Requests that propose combination use with other CSFs, concurrent radiation therapy, or administration with weekly chemotherapy regimens are excluded from coverage.

Do not combine with other colony stimulating factors within any chemotherapy cycle
Not for use during concurrent radiation therapy
Not to be used with weekly chemotherapy regimens

Prior Authorization

Continuation — criteria required

Continuation of therapy (including for new members) requires meeting all requirements in the coverage criteria; authorization for continuation may be denied if criteria are not met.

All continuation requests must meet the same coverage criteria as initial approvals
Failure to meet requirements may result in denial of continuation

Documentation Required

Documentation requirement and required risk-factor documentation

Documentation must include the member's diagnosis and the chemotherapeutic regimen. Required risk-factor documentation must state the presence or absence of patient risk factors for febrile neutropenia (examples include active infection, age ≥65, bone marrow involvement by tumor, prior chemo/radiation, poor nutritional or performance status, prior FN episodes, renal/liver dysfunction, HIV, cardiovascular disease, persistent neutropenia). If regimen FN risk is ≤20%, documentation must explicitly justify high-risk status using these risk factors.

Document member diagnosis and specific chemotherapeutic regimen
If regimen FN risk ≤20% provide documentation of patient risk factors (see Appendix C)
List presence or absence of each relevant risk factor when applicable

Note

Provider action note

Provider note: Render operational prior authorization information as part of the request — include clinical rationale, prior FN events or dose-limiting neutropenic events if requesting secondary prophylaxis, and planned chemotherapy dosing/schedule to demonstrate equivalence to prior cycle when applicable.

For secondary prophylaxis, document prior FN complication or dose-limiting neutropenic event from a prior cycle of similar chemotherapy at the same dose and schedule
Include planned dosing and schedule to establish similarity to the prior cycle

Tumor-Type Specific Regimens and Indications

Regimen / Indication	Coverage stance	Notes
pegfilgrastim (Neulasta and biosimilars) — primary prophylaxis for chemotherapy regimens with >20% FN risk; selected intermediate- or low-risk regimens when patient has required risk factors; secondary prophylaxis after prior FN or dose-limiting neutropenic event; other authorized indications (stem cell transplantation-related, hematopoietic subsyndrome of acute radiation syndrome, treatment for radiation-induced myelosuppression, hairy cell leukemia with neutropenic fever)
General administration limits
Not to be used in combination with other colony-stimulating factors during any chemotherapy cycle; not administered concurrently with radiation therapy; not administered with weekly chemotherapy regimens. Authorization up to 6 months when criteria met.

Tumor type / Regimen	Coverage stance	Notes
Acute Lymphoblastic Leukemia — select ALL regimens as directed by treatment protocol (see NCCN guidelines ALL)

Refer to NCCN treatment protocols for regimen-specific use and FN risk assessment.

Tumor type / Regimen	Coverage stance	Notes
Breast cancer — Dose-dense AC followed by dose-dense paclitaxel
TAC (docetaxel, doxorubicin, cyclophosphamide)
TC (docetaxel, cyclophosphamide); TCH (docetaxel, carboplatin, trastuzumab)

Tumor type / Regimen	Coverage stance	Notes
Non-Hodgkin's lymphoma — CHP + brentuximab vedotin
DA-EPOCH ± rituximab; ICE ± rituximab; CHOP variants; MINE; DHAP; ESHAP; HyperCVAD ± rituximab
Pola-R-CHP (polatuzumab vedotin + rituximab + cyclophosphamide/doxorubicin/prednisone)

Tumor type / Regimen	Coverage stance	Notes
Hodgkin lymphoma — Brentuximab vedotin + AVD
Nivolumab + AVD
Escalated BEACOPP; BrECADD

Tumor type / Regimen	Coverage stance	Notes
Ovarian cancer — Topotecan ± bevacizumab

Tumor type / Regimen	Coverage stance	Notes
Small cell lung cancer — Topotecan

Tumor type / Regimen	Coverage stance	Notes
Multiple myeloma — VTD-PACE
DT-PACE

Tumor type / Regimen	Coverage stance	Notes
Bone cancer — VAIA (vincristine, doxorubicin, ifosfamide, dactinomycin)
VDC-IE; Cisplatin/doxorubicin; VDC; VIDE

Tumor type / Regimen	Coverage stance	Notes
Testicular cancer — VelP (vinblastine, ifosfamide, cisplatin)
VIP (etoposide, ifosfamide, cisplatin); TIP (paclitaxel, ifosfamide, cisplatin)

Tumor type / Regimen	Coverage stance	Notes
Gestational trophoblastic neoplasia — EMA/EP; EP/EMA; TP/TE; BEP; TIP; VIP; ICE

Tumor type / Regimen	Coverage stance	Notes
Wilms tumor — Regimen M; Regimen I; Revised Regimen UH-1; Revised Regimen UH-2

Tumor type / Regimen	Coverage stance	Notes
Bladder cancer — Dose-dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)

Tumor type / Regimen	Coverage stance	Notes
Kidney cancer — Doxorubicin/gemcitabine

Tumor type / Regimen	Coverage stance	Notes
Melanoma — Dacarbazine-based combination with IL-2, interferon alpha

Tumor type / Regimen	Coverage stance	Notes
Soft tissue sarcoma — MAID (mesna, doxorubicin, ifosfamide, dacarbazine)
Doxorubicin; Ifosfamide/doxorubicin

Regimen	Coverage stance	Notes
Wilms Tumor regimens (Regimen M; Regimen I; Revised UH-1; Revised UH-2) associated with intermediate FN risk
Applies when assessing need for prophylactic growth factor support; specific agent lists provided in document

Regimen(s)	Coverage stance	Notes
Breast cancer regimens listed with intermediate FN risk — Docetaxel ± trastuzumab
AC + sequential docetaxel (taxane portion only); Paclitaxel every 21 days ± trastuzumab; Sacituzumab govitecan-hziy; TC (docetaxel, cyclophosphamide)

Regimen	Coverage stance	Notes
FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, irinotecan) — listed for colorectal and pancreatic cancers as intermediate FN risk

Regimen(s)	Coverage stance	Notes
Non-Hodgkin's lymphoma intermediate-risk regimens — GDP ± rituximab; CHOP ± rituximab (including pegylated liposomal doxorubicin); Bendamustine

Definitions

Neulasta indication (definitions)

Indication summaryPegfilgrastim is indicated to decrease the incidence of infection manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Product namingNeulasta and biosimilars (pegfilgrastim) referenced in policy and compendia

Clinical settingUsed for primary and secondary prophylaxis of chemotherapy-induced febrile neutropenia per policy criteria

Radiation syndrome indication (definitions)

IndicationIncrease survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Authorized useIncluded among other authorized indications for which 6-month authorization may be granted when criteria are met

SourceNeulasta product labeling referenced in policy

High-risk regimens (definitions)

High-risk definitionRegimens with >20% incidence of febrile neutropenia (listed in Appendix A).

Appendix guidanceAppendix A contains selected examples but is not comprehensive

Coverage implicationPrimary prophylaxis with pegfilgrastim is supported for these regimens when criteria are met

Intermediate-risk regimens (definitions)

Intermediate-risk definitionRegimens with a 10%–20% incidence of febrile neutropenia (listed in Appendix B).

Appendix completenessAppendix B is not comprehensive; other regimens may also fall into this category

Clinical useConsider prophylactic G-CSF when regimen risk combined with patient risk factors justifies its use

Patient risk factors for FN (definitions)

Patient risk factors (summary)Clinical or demographic features that increase FN risk: active infection, age ≥65, bone marrow tumor involvement, prior chemo/radiation, poor nutrition, poor performance status, prior FN, serious comorbidities (renal/liver dysfunction, HIV, cardiovascular disease), persistent neutropenia.

Documentation requirementPresence or absence of these risk factors must be documented when regimen FN risk is ≤20%

List completenessAppendix C is not all-inclusive; other factors may increase FN risk

OpenPayer

Pegfilgrastim (Neulasta and biosimilars) — Prevention and Treatment of Febrile Neutropenia

Coverage Criteria for Pegfilgrastim and Biosimilars

Risk Thresholds and Definitions

Prior Authorization, Documentation, and Continuation Rules

Tumor-Type Specific Regimens and Indications

Therapy Line Considerations

Background and Indications

Definitions