Neighborhood Health Plan RI pegfilgrastim Coverage

Coverage Criteria for Pegfilgrastim and Biosimilars

Prevention of Neutropenia in Cancer Patients Receiving Myelosuppressive Chemotherapy

Authorization for prevention of febrile neutropenia (up to 6 months) when ALL of the following are met:

General criteria: The 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 they receive radiation therapy; the requested medication will not be administered with weekly chemotherapy regimens.

Primary prophylaxis criteria: The requested medication will be used for primary prophylaxis in members with a solid tumor or non-myeloid malignancy who have received, are currently receiving, or will be receiving myelosuppressive anti-cancer therapy that is expected to result in greater than 20% incidence of febrile neutropenia (See Appendix A) OR expected to result in 10–20% risk of FN (See Appendix B) and who are considered to be at high risk of FN because of bone marrow compromise, comorbidities, or other patient-specific risk factors (See Appendix C) OR expected to result in less than 10% risk of FN and who have at least 2 patient-related risk factors (See Appendix C).

References to Appendices A-C for regimen and risk factor lists.

Secondary prophylaxis criteria: The requested medication will be used for secondary prophylaxis in members with solid tumors or non-myeloid malignancies who experienced a febrile neutropenic complication or a dose-limiting neutropenic event from a prior cycle of similar chemotherapy, with the same dose and schedule planned for the current cycle (and primary prophylaxis was not received).

Other Indications

Other covered indications (authorization of 6 months may be granted):

Other 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.

Continuation Therapy

Continuation of Therapy

Continuation authorization requirement: All members (including new members) requesting authorization for continuation of therapy must meet all requirements in the coverage criteria.

applies to continuation requests

Regimens by Febrile Neutropenia Risk

Regimen risk groupings

High-risk regimens: Chemotherapy regimens listed in Appendix A are associated with an incidence of febrile neutropenia greater than 20%.>20%

This list is not comprehensive; there are other agents/regimens with similar risk.

Intermediate-risk regimens: Chemotherapy regimens listed in Appendix B are associated with an incidence of febrile neutropenia of 10% to 20%.10-20%

This list is not comprehensive; there are other agents/regimens with similar risk.

Prophylactic pegfilgrastim for intermediate-risk regimens with patient risk factors

Covered when ALL of the following context elements are consistent with policy guidance

Regimen risk: Patient is receiving a chemotherapy regimen listed in Appendix B identified as having an incidence of febrile neutropenia of 10% to 20% (examples include FOLFIRINOX; CHOP or GDP for non-Hodgkin's lymphoma; cisplatin/paclitaxel and other non-small cell lung regimens; docetaxel-containing breast regimens; cabazitaxel; BEP; etoposide/carboplatin; gemcitabine/docetaxel; docetaxel for uterine sarcoma).10-20% FN incidence

Appendix B provides regimen examples; list is not comprehensive.

Patient risk factors: Presence of one or more patient risk factors from Appendix C that increase FN risk (examples: active infection, open wounds or recent surgery; age ≥65 years; bone marrow involvement by tumor producing cytopenias; previous chemotherapy or radiation therapy; poor nutritional status; poor performance status; previous episodes of FN; other serious comorbidities such as renal or liver dysfunction, HIV, cardiovascular disease; persistent neutropenia).one or more risk factors

Appendix C list is not all-inclusive.

All indications not explicitly listed as FDA-approved or compendial uses (for example: 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.

No additional exclusion text provided for this placeholder. Refer to the policy's compendial use list and coverage criteria for permitted indications and to Appendix A–C for regimen and patient risk factor guidance when assessing requests.

Chemotherapy regimens that are not listed in Appendix B (intermediate risk) or Appendix A (high risk), and members who do not have additional patient-level risk factors from Appendix C, are implicitly excluded from routine primary prophylaxis. Appendix B is not comprehensive; absence from the lists indicates prophylaxis is not supported unless other coverage criteria or compendial indications apply.

Uses that are not described in the policy's compendial indications or the listed covered indication sections are considered not medically necessary. Providers should document that the requested use matches an FDA‑approved or compendial indication to support coverage.

No additional exclusion text provided for this placeholder. Evaluate requests using the policy's specified regimen risk groupings, patient risk factors in Appendix C, and compendial indications.

The policy excludes routine use of pegfilgrastim for chemotherapy regimens that lack documentation of being intermediate or high febrile neutropenia (FN) risk or for patients without documented patient-level risk factors. Specifically, routine prophylaxis is not supported for regimens not identified in Appendix A (>20% FN risk) or Appendix B (10–20% FN risk) unless one or more Appendix C patient risk factors are documented.

Risk Thresholds and Coding Notes

FN risk thresholds

High FN risk thresholdGreater than 20% incidence of febrile neutropenia (primary prophylaxis indicated)

Intermediate FN risk thresholdApproximately 10%–20% incidence of febrile neutropenia (prophylaxis considered when patient has high-risk factors)

Low FN risk + patient factorsLess than 10% FN risk — prophylaxis may be considered if member has at least 2 patient-related risk factors

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization and continuation

Authorization may be granted for up to 6 months when the specified coverage criteria are met. Continuation requests for all members (including new members) must meet all coverage criteria; failure to document that requirements are met may result in denial.

Authorization duration: up to 6 months
Continuation requests: must satisfy all coverage criteria

Prior Authorization

Continuation therapy requires authorization

Continuation of therapy for all members requires prior authorization and must satisfy the coverage criteria outlined in the policy. Providers requesting continuation must document that the member continues to meet the original coverage criteria.

Continuation applies to new members as well
Document ongoing fulfillment of criteria for continuation

Chemotherapy Regimens and Indications

Regimen group	Regimens / Examples	Coverage stance
Selected chemotherapy regimens with incidence of FN >20% (Appendix A — list not comprehensive)
See Appendix A for examples of regimens associated with an incidence of febrile neutropenia greater than 20%.
Primary prophylaxis when regimen FN risk >20% (see Appendix A)

Cancer type	Regimen / Instruction	Coverage stance
Acute Lymphoblastic Leukemia
Select ALL regimens as directed by treatment protocol (see NCCN guidelines ALL)
Informational — follow NCCN ALL guidance

Cancer type	Regimen	Coverage stance
Bladder Cancer
Dose dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)
Informational

Cancer type	Regimens	Coverage stance
Bone Cancer
VAIA; VDC-IE; Cisplatin/doxorubicin; VDC; VIDE
Informational

Cancer type	Regimens	Coverage stance
Breast Cancer
Dose-dense AC followed by dose-dense paclitaxel; TAC; TC; TCH
Informational

Cancer type	Regimen	Coverage stance
Head and Neck Squamous Cell Carcinoma
TPF (docetaxel, cisplatin, 5-fluorouracil)
Informational

Cancer type	Regimens	Coverage stance
Hodgkin Lymphoma
Brentuximab vedotin + AVD; Nivolumab + AVD; Escalated BEACOPP; BrECADD
Informational

Cancer type	Regimens	Coverage stance
Non-Hodgkin's Lymphoma
CHP + brentuximab; Dose-adjusted EPOCH ± rituximab; ICE ± rituximab; Dose-dense CHOP-14 ± rituximab; CHOP; MINE ± rituximab; DHAP ± rituximab; ESHAP ± rituximab; HyperCVAD ± rituximab; Pola-R-CHP
Informational

Cancer type	Regimen	Coverage stance
Melanoma
Dacarbazine-based combination with IL-2, interferon alpha
Informational

Cancer type	Regimens	Coverage stance
Multiple Myeloma
VTD-PACE; DT-PACE
Informational

Cancer type	Regimens	Coverage stance
Ovarian Cancer
Topotecan ± bevacizumab; Docetaxel; Carboplatin/docetaxel
Informational

Cancer type	Regimens	Coverage stance
Soft Tissue Sarcoma
MAID; Doxorubicin; Ifosfamide/doxorubicin
Informational

Cancer type	Regimen	Coverage stance
Small Cell Lung Cancer
Topotecan
Informational

Cancer type	Regimens	Coverage stance
Testicular Cancer
VelP; VIP; TIP
Informational

Cancer type	Regimens	Coverage stance
Gestational Trophoblastic Neoplasia
EMA/EP; EP/EMA; TP/TE; BEP; TIP; VIP; ICE
Informational

Cancer type	Regimens	Coverage stance
Wilms Tumor
Regimen M; Regimen I; Revised Regimen UH-1; Revised Regimen UH-2 (applies to regimens with or without monoclonal antibodies)
Informational

Cancer type	Regimen	Coverage stance
Occult Primary - Adenocarcinoma
Gemcitabine/docetaxel
Informational

Category	Regimen (components)	Coverage stance
Chemotherapy regimens with intermediate FN risk
FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, irinotecan)
Covered when criteria for intermediate-risk regimens are met (see policy)

Cancer type / Group	Regimens	Coverage stance
Non-Hodgkin's Lymphoma (intermediate FN risk)
CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) and GDP (gemcitabine, dexamethasone, cisplatin/carboplatin), with or without rituximab
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimens	Coverage stance
Breast cancer (intermediate FN risk)
Docetaxel ± trastuzumab; AC + sequential docetaxel ± trastuzumab; Paclitaxel every 21 days ± trastuzumab; Sacituzumab govitecan-hziy; TC (docetaxel, cyclophosphamide)
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimens	Coverage stance
Non-small cell lung cancer (intermediate FN risk)
Cisplatin/paclitaxel; Cisplatin/vinorelbine; Cisplatin/docetaxel; Cisplatin/etoposide; Carboplatin/paclitaxel; Docetaxel
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimen	Coverage stance
Prostate cancer (intermediate FN risk)
Cabazitaxel
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimens	Coverage stance
Testicular cancer (intermediate FN risk)
BEP (bleomycin, etoposide, cisplatin); Etoposide/cisplatin
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimen	Coverage stance
Small cell lung cancer (intermediate FN risk)
Etoposide/carboplatin
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimen	Coverage stance
Esophageal/gastric cancer (intermediate FN risk)
Irinotecan/cisplatin
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimens	Coverage stance
Cervical cancer (intermediate FN risk)
Irinotecan; Cisplatin/topotecan; Paclitaxel/cisplatin ± bevacizumab; Topotecan
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimen	Coverage stance
Occult primary adenocarcinoma (intermediate FN risk)
Gemcitabine/docetaxel
Covered when patient has additional risk factors per Appendix C

Cancer type	Regimen	Coverage stance
Uterine sarcoma (intermediate FN risk)
Docetaxel
Covered when patient has additional risk factors per Appendix C

Key Definitions and Appendices

Febrile neutropenia (FN)

DefinitionClinical condition of infection risk manifested by fever in the setting of neutropenia associated with myelosuppressive anti-cancer therapy.

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

Associated settingsOccurs in patients receiving myelosuppressive chemotherapy and may warrant primary or secondary prophylaxis per regimen and patient risk factors.

Selected chemotherapy regimens with incidence of febrile neutropenia

Appendix ALists selected chemotherapy regimens associated with >20% incidence of febrile neutropenia (list is not comprehensive).

Appendix B

Line of Therapy Notes

informational

informational: Used with myelosuppressive therapy expected to cause specified FN risk levels as per Appendices; primary prophylaxis applies to patients receiving or planned to receive such therapy.

This is informational guidance on line of therapy.

Background on Pegfilgrastim and Indications

Pegfilgrastim (Neulasta) and the listed pegfilgrastim biosimilars are indicated to decrease the incidence of infection manifested by febrile neutropenia (FN) in patients with non‑myeloid malignancies receiving myelosuppressive anti‑cancer therapy, and compendial uses (e.g., stem cell transplantation) are included where criteria are met. Appendix B lists regimens with an estimated FN incidence of 10%–20% and Appendix C lists patient risk factors (for example, age >= 65 years, active infection, bone marrow involvement, prior FN, poor performance or nutritional status, significant comorbidities, or persistent neutropenia) that influence prophylaxis decisions.

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Pegfilgrastim (Neulasta) and Pegfilgrastim Biosimilars - Coverage Criteria