BlueCross BlueShield of Tennessee Medical Policy Manual
Pegfilgrastim (Neulasta®); Pegfilgrastim-jmdb (Fulphila®); Pegfilgrastim--pbbk (Fylnetra®); Pegfilgrastim-apgf (Nyvepria™); Pegfilgrastim-fpgk (Stimufed®); Pegfilgrastim-cbqv (Udenyca®); Pegfilgrastim-bmez (Ziextenzo™)
Some agents on this policy may require step therapy See “Step Therapy Requirements for Provider Administered Specialty Medications” Document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Neulasta
Patients with Cancer Receiving Myelosuppressive Chemotherapy
Neulasta 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 with a clinically significant incidence of febrile neutropenia.
Hematopoietic Subsyndrome of Acute Radiation Syndrome
Neulasta is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
Fulphila
Patients with Cancer Receiving Myelosuppressive Chemotherapy
Fulphila 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 with a clinically significant incidence of febrile neutropenia
Udenyca
Patients with Cancer Receiving Myelosuppressive Chemotherapy
Udenyca 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 with a clinically significant incidence of febrile neutropenia.
Hematopoietic Subsyndrome of Acute Radiation Syndrome
Udenyca is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Ziextenzo
Patients with Cancer Receiving Myelosuppressive Chemotherapy
Ziextenzo 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 with a clinically significant incidence of febrile neutropenia.
Hematopoietic Subsyndrome of Acute Radiation Syndrome
Ziextenzo is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Nyvepria
Patients with Cancer Receiving Myelosuppressive Chemotherapy
Nyvepria 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 with a clinically significant incidence of febrile neutropenia.
Fylnetra
Patients with Cancer Receiving Myelosuppressive Chemotherapy
Fylnetra 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 with a clinically significant incidence of febrile neutropenia.
Stimufend
Patients with Cancer Receiving Myelosuppressive Chemotherapy
Stimufend 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 with a clinically significant incidence of febrile neutropenia.
Hematopoietic Subsyndrome of Acute Radiation Syndrome
Stimufend is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation.
Compendial Use
All other indications are considered experimental/investigational and not medically necessary.
DOCUMENTATION
Primary Prophylaxis of Febrile Neutropenia
COVERAGE CRITERIA
Prevention of Neutropenia in Cancer Patients Receiving Myelosuppressive Chemotherapy
Authorization of 6 months may be granted for prevention of febrile neutropenia when all of the following criteria are met:
OTHER INDICATIONS
Authorization of 6 months may be granted for members with any of the following indications:
CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
APPENDIX
APPENDIX A: Selected Chemotherapy Regimens with an Incidence of Febrile Neutropenia of 20% or Higher
This list is not comprehensive; there are other agents/regimens that have an intermediate/high risk for development of febrile neutropenia.
Acute Lymphoblastic Leukemia
Select ALL regimens as directed by treatment protocol (see NCCN guidelines ALL)
Bladder Cancer
Dose dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)
Bone Cancer
ifosfamide and etoposide)
Breast Cancer
Head and Neck Squamous Cell Carcinoma
TPF (docetaxel, cisplatin, 5-fluorouracil)
Hodgkin Lymphoma:
Kidney Cancer
Doxorubicin/gemcitabine
Non-Hodgkin's Lymphoma
Melanoma
Dacarbazine-based combination with IL-2, interferon alpha (dacarbazine, cisplatin, vinblastine, IL-2, interferon alfa)
Multiple Myeloma
Ovarian Cancer
Soft Tissue Sarcoma
Small Cell Lung Cancer
Topotecan
Testicular Cancer
Gestational Trophoblastic Neoplasia
Wilms Tumor
Applies to chemotherapy regimens with or without monoclonal antibodies (e.g., trastuzumab, rituximab)
APPENDIX B: Selected Chemotherapy Regimens with an Incidence of Febrile Neutropenia of 10% to 19%
This list is not comprehensive; there are other agents/regimens that have an intermediate/high risk for development of febrile neutropenia.
Occult Primary – Adenocarcinoma
Gemcitabine/docetaxel
Breast Cancer
Cervical Cancer
Colorectal Cancer
FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, irinotecan)
Esophageal and Gastric Cancers
Irinotecan/cisplatin
Non-Hodgkin's Lymphomas
Non-Small Cell Lung Cancer
Ovarian Cancer
Carboplatin/docetaxel
Pancreatic Cancer
FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, irinotecan)
Prostate Cancer
Cabazitaxel
Small Cell Lung Cancer
Etoposide/carboplatin
Testicular Cancer:
Uterine Sarcoma:
Docetaxel
Applies to chemotherapy regimens with or without monoclonal antibodies (e.g., trastuzumab, rituximab)
APPENDIX C: Patient Risk Factors
This list is not all-inclusive.
MEDICATION QUANTITY LIMITS
|
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
|
Neulasta (Pegfilgrastim) Udenyca (Pegfilgrastim-cbqv) |
Hematopoietic Subsyndrome of Acute Radiation Syndrome |
Route of Administration: Subcutaneous ≥18 Years 6mg every week for 2 doses
≤17 Years <10kg: 0.1mg/kg every week for 2 doses 10-20kg: 1.5mg every week for 2 doses 21-30kg: 2.5mg every week for 2 doses 31-44kg: 4mg every week for 2 doses ≥45kg: 6mg every week for 2 doses
|
|
Fulphila (Pegfilgrastim-jmdb) Fylnetra (Pegfilgrastim-pbbk) Nyvepria (Pegfilgrastim-apgf) Stimufend (Pegfilgrastim-fpgk) Ziextenzo (Pegfilgrastim-bmez) |
Hematopoietic Subsyndrome of Acute Radiation Syndrome |
Route of Administration: Subcutaneous ≥ 18 Years 6mg every week for 2 doses
<18 Years <10kg: 0.1mg/kg every week for 2 doses > 10kg to <21kg: 1.5mg every week for 2 doses > 21kg to < 31kg: 2.5mg every week for 2 doses > 31kg to <45kg: 4mg every week for 2 doses > 45kg: 6mg every week for 2 doses |
|
Ziextenzo (Pegfilgrastim-bmez) |
Prevention of Febrile Neutropenia |
Route of Administration: Subcutaneous ≤18 Years <10kg 0.1mg/kg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
10-20kg 1.5mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
21-30kg 2.5mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy 31-44kg 4mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
≥45kg 6mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
≥18 Years 6mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy |
|
Fulphila (Pegfilgrastim-jmdb) Fylnetra (Pegfilgrastim-pbbk) Nyvepria (Pegfilgrastim-apgf) Stimufed (Pegfilgrastim-fpgk) Udenyca (Pegfilgrastim-cbqv)
|
Prevention of Febrile Neutropenia |
Route of Administration: Subcutaneous ≤17 Years <10kg 0.1mg/kg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
10-20kg 1.5mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
21-30kg 2.5mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy 31-44kg 4mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
≥45kg 6mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy
≥18 Years 6mg once per chemotherapy cycle; do not administer between 14 days prior to and 24 hours after administration of chemotherapy |
|
Neulasta (Pegfilgrastim) Fulphila (Pegfilgrastim-jmdb) Fylnetra (Pegfilgrastim-pbbk) Nyvepria (Pegfilgrastim-apgf) Stimufed (Pegfilgrastim-fpgk) Udenyca (Pegfilgrastim-cbqv) Ziextenzo (Pegfilgrastim-bmez)
|
Stem Cell Transplantation-Related Indications |
Route of Administration: Subcutaneous 6mg once |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 4/2/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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