Neighborhood Health Plan RI pegfilgrastim Coverage

Coverage and Medical Necessity Criteria

Prevention of neutropenia in cancer patients receiving myelosuppressive chemotherapy

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

Initial approval core requirements: (1) The requested medication will not be used in combination with other colony stimulating factors within any chemotherapy cycle; (2) The member will not receive chemotherapy at the same time as radiation therapy; (3) The requested medication will not be administered with weekly chemotherapy regimens; (4) One of the following (primary prophylaxis OR secondary prophylaxis) is met.

Primary prophylaxis options: i. Use for primary prophylaxis in members with solid tumor or non-myeloid malignancies who have received, are currently receiving, or will receive: a) myelosuppressive anti-cancer therapy expected to result in >=20% incidence of febrile neutropenia (See Appendix A); OR b) myelosuppressive anti-cancer therapy expected to result in 10-19% FN risk (See Appendix B) AND the member is considered high risk because of bone marrow compromise, comorbidities, or other patient-specific risk factors (See Appendix C); OR c) myelosuppressive therapy expected to result in <10% FN risk AND the member has at least 2 patient-related risk factors (See Appendix C).see Appendix A, B, C

Appendices list regimens and risk factors

Secondary prophylaxis: ii. Use 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 (for which primary prophylaxis was not received).

Other indications

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

Other covered 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, including neutropenic fever following chemotherapy.

All indications that are not specifically listed among the FDA-approved indications or recognized compendial uses are considered experimental/investigational and not medically necessary. The compendial uses explicitly include stem cell transplantation–related indications, prophylaxis for chemotherapy‑induced febrile neutropenia in patients with solid tumors, Hematopoietic Subsyndrome of Acute Radiation Syndrome, and hairy cell leukemia with neutropenic fever; uses outside those listed categories are not covered.

The appendices list selected chemotherapy regimens and related information to help classify febrile neutropenia (FN) risk but do not state explicit exclusions. The appendices include numerous regimen examples (see Appendix B: selected regimens with 10%–19% FN incidence and other regimen listings) and note that the lists are not comprehensive, meaning additional regimens with similar FN risk may exist but are not enumerated here.

Use of pegfilgrastim or its biosimilars for any indication beyond those specified in the FDA‑approved labeling or recognized compendial uses (as enumerated in this policy) is considered not medically necessary and is therefore excluded from coverage.

The appendix material provided contains regimen lists, notes, and references but does not include statements that label particular uses as explicitly 'not medically necessary' within these appendix chunks. The appendices instead provide illustrative regimen examples and a reminder that the lists are not comprehensive.

Listed Chemotherapy Regimens and FN Risk Classification

Regimen (Appendix A)	Cancer type / notes
Dose dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)
Bladder cancer
CBDCa/Pac (carboplatin, paclitaxel)
Bladder cancer
VAI (vincristine, doxorubicin or dactinomycin, ifosfamide)
Bone cancer
VDC-IE (vincristine, doxorubicin or dactinomycin, and cyclophosphamide alternating with ifosfamide and etoposide)
Bone cancer
Cisplatin/doxorubicin
Bone cancer
VDC (cyclophosphamide, vincristine, doxorubicin or dactinomycin)
Bone cancer
VIDE (vincristine, ifosfamide, doxorubicin or dactinomycin, etoposide)
Bone cancer
Docetaxel + trastuzumab
Breast cancer
Dose-dense AC (doxorubicin, cyclophosphamide) + paclitaxel (or dose dense paclitaxel)
Breast cancer
TAC (docetaxel, doxorubicin, cyclophosphamide)
Breast cancer
AT (doxorubicin, docetaxel)
Breast cancer
Doc (docetaxel)
Breast cancer
TC (docetaxel, cyclophosphamide)
Breast cancer
TCH (docetaxel, carboplatin, trastuzumab)
Breast cancer
FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, irinotecan)
Colorectal cancer
Docetaxel/cisplatin/fluorouracil
Esophageal and gastric cancers
TPF (docetaxel, cisplatin, 5-fluorouracil)
Head and neck squamous cell carcinoma
Brentuximab vedotin + AVD
Hodgkin lymphoma
Escalated BEACOPP
Hodgkin lymphoma
Doxorubicin/gemcitabine
Kidney cancer
CHP + brentuximab vedotin
Non-Hodgkin's lymphoma
Dose-adjusted EPOCH
Non-Hodgkin's lymphoma
ICE (ifosfamide, carboplatin, etoposide)
Non-Hodgkin's lymphoma
Dose-dense CHOP-14 ± rituximab
Non-Hodgkin's lymphoma
MINE (mesna, ifosfamide, mitoxantrone, etoposide)
Non-Hodgkin's lymphoma
DHAP (dexamethasone, cisplatin, cytarabine)
Non-Hodgkin's lymphoma
ESHAP (etoposide, methylprednisolone, cisplatin, cytarabine)
Non-Hodgkin's lymphoma
HyperCVAD ± rituximab
Non-Hodgkin's lymphoma
VAPEC-B
Non-Hodgkin's lymphoma
Dacarbazine-based combination with IL-2, interferon alpha
Melanoma
VTD-PACE (dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide + bortezomib)
Multiple myeloma
DT-PACE (dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide)
Multiple myeloma
Topotecan
Ovarian cancer
Docetaxel
Ovarian cancer
MAID (mesna, doxorubicin, ifosfamide, dacarbazine)
Soft tissue sarcoma
Doxorubicin
Soft tissue sarcoma
Ifosfamide/doxorubicin
Soft tissue sarcoma
Top (topotecan)
Small cell lung cancer
CAV (cyclophosphamide, doxorubicin, vincristine)
Small cell lung cancer
VelP (vinblastine, ifosfamide, cisplatin)
Testicular cancer
VIP (etoposide, ifosfamide, cisplatin)
Testicular cancer
TIP (paclitaxel, ifosfamide, cisplatin)
Testicular cancer
EMA/CO; EMA/EP
Gestational trophoblastic neoplasia
Regimen M; Regimen I
Wilms tumor

Regimen (Appendix B)	Cancer type / notes
Gemcitabine/docetaxel
Occult primary - adenocarcinoma
Docetaxel
Breast cancer; Non-small cell lung cancer (listed elsewhere)
CMF classic (cyclophosphamide, methotrexate, fluorouracil)
Breast cancer
CA (doxorubicin, cyclophosphamide) (60 mg/m2) (hospitalized)
Breast cancer
AC (doxorubicin, cyclophosphamide) + sequential docetaxel (taxane portion only)
Breast cancer
AC + sequential docetaxel + trastuzumab
Breast cancer
A (doxorubicin) (75 mg/m2)
Breast cancer
AC (doxorubicin, cyclophosphamide)
Breast cancer
CapDoc (capecitabine, docetaxel)
Breast cancer
Paclitaxel every 21 days
Breast cancer
Irinotecan
Cervical cancer; Esophageal/gastric cancers (related regimens listed)
Cisplatin/topotecan
Cervical cancer
Paclitaxel/cisplatin
Cervical cancer
Topotecan
Cervical cancer
FL (fluorouracil, leucovorin)
Colorectal cancer
CPT-11 (irinotecan) (350 mg/m2 q 3 wk)
Colorectal cancer
FOLFOX (fluorouracil, leucovorin, oxaliplatin)
Colorectal cancer
FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, irinotecan)
Colorectal; Pancreatic cancer (also listed)
Irinotecan/cisplatin
Esophageal and gastric cancers
Epirubicin/cisplatin/5-fluorouracil
Esophageal and gastric cancers
Epirubicin/cisplatin/capecitabine
Esophageal and gastric cancers
EPOCH-IT chemotherapy
Non-Hodgkin's lymphoma
GDP (gemcitabine, dexamethasone, cisplatin/carboplatin)
Non-Hodgkin's lymphoma
GDP + rituximab
Non-Hodgkin's lymphoma
FMR (fludarabine, mitoxantrone, rituximab)
Non-Hodgkin's lymphoma
CHOP (including pegylated liposomal doxorubicin)
Non-Hodgkin's lymphoma
CHOP + rituximab
Non-Hodgkin's lymphoma
Bendamustine
Non-Hodgkin's lymphoma
Cisplatin/paclitaxel
Non-small cell lung cancer
Cisplatin/vinorelbine
Non-small cell lung cancer
Cisplatin/docetaxel
Non-small cell lung cancer
Cisplatin/etoposide
Non-small cell lung cancer
Carboplatin/paclitaxel
Non-small cell lung cancer
Docetaxel
Non-small cell lung cancer; also listed for breast cancer
Carboplatin/docetaxel
Ovarian cancer; Non-small cell lung cancer
FOLFIRINOX
Pancreatic cancer; Colorectal cancer
Cabazitaxel
Prostate cancer
Etoposide/carboplatin
Small cell lung cancer
BEP (bleomycin, etoposide, cisplatin)
Testicular cancer
Etoposide/cisplatin
Testicular cancer
Docetaxel
Uterine sarcoma

Appendix entries are intended to assist in classifying chemotherapy regimens by febrile neutropenia risk but do not serve as an exhaustive or exclusive list for coverage decisions. They explicitly state that the lists are not comprehensive, and no explicit exclusions are provided within these appendix sections.

Document Identifiers, Risk Thresholds, and Coding References

Document/reference identifiersmixed

1931-A

Reference/document number printed on the Neulasta and biosimilars document

FN risk thresholds

High FN risk>=20%

Intermediate FN risk10-19%

Low FN risk<10%

Febrile neutropenia incidence range

Intermediate-risk incidence range10% - 19%

Examples of regimens in this rangeSee Appendix B for specific regimens such as Gemcitabine/docetaxel; Docetaxel; CMF; FOLFOX; FOLFIRINOX; CHOP +/- rituximab

Note on completeness

Prior Authorization, Documentation, and Provider Requirements

Note

Provider Actions Summary

Prior authorization is not explicitly specified within the appended regimen and reference appendices. However, when prior authorization is required by the payer, requests should include the clinical documentation described below. Note: use for indications not listed in FDA-approved indications or recognized compendia is considered experimental/investigational and will be denied as not medically necessary.

Appendices list regimens and risk factors but do not themselves define authorization or denial rules.
Experimental/Investigational exclusion: Any use outside FDA-approved indications or accepted compendial uses (see Compendial Use list) is considered experimental/investigational and not medically necessary.
No step therapy rules are defined in the appended text.
Required documentation for prophylaxis: member's diagnosis and the specific chemotherapeutic regimen must be provided. If the regimen has <20% FN risk, documentation must also demonstrate the member's individual high-risk factors (see Appendix C) or at least two patient-related risk factors for regimens with <10% FN risk.

Documentation Required

Documentation Requirements

Definitions and Risk Factor Lists

Primary prophylaxis — Febrile neutropenia prevention

DefinitionUse of pegfilgrastim to reduce the incidence of infection manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Indications includedPrimary prophylaxis for myelosuppressive chemotherapy meeting FN risk thresholds; secondary prophylaxis after prior FN or dose-limiting neutropenic event.

Authorization durationPrior authorization may be granted for up to 6 months when initial criteria are met.

Intermediate-risk chemotherapy regimens

DefinitionChemotherapy regimens associated with an incidence of febrile neutropenia of 10% to 19% (intermediate risk).

Representative regimens

First-line and Subsequent Use

first-line | subsequent

Line of therapy: Primary or secondary prophylaxis: Primary prophylaxis for patients starting or receiving myelosuppressive chemotherapy that meets the febrile neutropenia risk criteria (see primary prophylaxis options); Secondary prophylaxis for patients who experienced febrile neutropenia or a dose-limiting neutropenic event on a prior similar chemotherapy cycle without prior primary prophylaxis.

Clinical Background and Indications

Pegfilgrastim and pegfilgrastim biosimilars are indicated to decrease the incidence of infection manifested by febrile neutropenia in patients with non‑myeloid malignancies receiving myelosuppressive anti‑cancer drugs. The document also references stem cell transplantation–related indications and Hematopoietic Subsyndrome of Acute Radiation Syndrome as compendial uses. Appendix material lists specific chemotherapy regimens and notes that the regimen lists are not comprehensive, which informs but does not expand coverage beyond the FDA‑approved and compendial indications.

Policy Revision History and References

Note

References and package inserts cited (used for policy/revision sources)

References and package inserts listed in the References section are also used as source material for the policy and revision history.

Reference list includes multiple pegfilgrastim product package inserts and guideline sources (see References)

OpenPayer

Pegfilgrastim (Neulasta) and pegfilgrastim biosimilars coverage