Eflapegrastim-xnst (Rolvedon™)
Requires 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
I. 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.
A. FDA-Approved Indication
Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
B. Compendial Uses
1. Stem cell transplantation-related indications
2. Prophylaxis for chemotherapy-induced febrile neutropenia in patients with solid tumors
3. Hematopoietic acute radiation syndrome
4. Hairy cell leukemia, neutropenic fever
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Primary Prophylaxis of Febrile Neutropenia
A. Documentation must be provided of the member’s diagnosis and chemotherapeutic regimen.
B. If chemotherapeutic regimen has an intermediate risk of febrile neutropenia (less than 20%) documentation must be provided outlining the member’s risk factors that confirm the member is at high risk for febrile neutropenia.
III. CRITERIA FOR INITIAL APPROVAL
A. 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 (1, 2, 3, and 4):
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 they receive radiation therapy
3. The requested medication will not be administered with weekly chemotherapy regimens.
4. One of the following criteria is met (i or ii):
i. The requested medication will be used for primary prophylaxis in members with a solid tumor or non-myeloid malignancies who have received, are currently receiving, or will be receiving any of the following:
a) Myelosuppressive anti-cancer therapy that is expected to result in 20% or higher incidence of febrile neutropenia (FN) (See Appendix A)
b) Myelosuppressive anti-cancer therapy that is expected to result in 10 – 19% risk of FN (See Appendix B) and who are considered to be at high risk of FN because of bone marrow compromise, co-morbidities, or other patient specific risk factors (See Appendix C).
c) Myelosuppressive anti-cancer therapy that is expected to result in less than 10% risk of FN and who have at least 2 patient-related risk factors (See Appendix C).
ii. 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 (a nadir or day of treatment count impacting the planned dose of chemotherapy) from a prior cycle of similar chemotherapy, with the same dose and scheduled planned for the current cycle (for which primary prophylaxis was not received)
B. Other indications
Authorization of 6 months may be granted for members with any of the following indications:
1. Stem cell transplantation-related indications
2. Hematopoietic Acute Radiation Syndrome
Treatment for radiation-induced myelosuppression following a radiological/nuclear incident
3. Hairy cell leukemia
Members with hairy cell leukemia with neutropenic fever following chemotherapy
IV. CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
V. APPENDIX
A. APPENDIX A: Selected Chemotherapy Regimens with an Incidence of Febrile Neutropenia of 20% or Higher*†
1. Acute Lymphoblastic Leukemia:
Select ALL regimens as directed by treatment protocol (see NCCN guidelines ALL)
2. Bladder Cancer:
i. Dose dense MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)
ii. CBDCa/Pac (carboplatin, paclitaxel)
3. Bone Cancer
i. VAI (vincristine, doxorubicin or dactinomycin, ifosfamide)
ii. VDC-IE (vincristine, doxorubicin or dactinomycin, and cyclophosphamide alternating with ifosfamide and etoposide)
iii. Cisplatin/doxorubicin
iv. VDC (cyclophosphamide, vincristine, doxorubicin or dactinomycin)
v. VIDE (vincristine, ifosfamide, doxorubicin or dactinomycin, etoposide)
4. Breast Cancer:
i. Docetaxel + trastuzumab
ii. Dose-dense AC (doxorubicin, cyclophosphamide) + paclitaxel (or dose dense paclitaxel)
iii. TAC (docetaxel, doxorubicin, cyclophosphamide)
iv. AT (doxorubicin, docetaxel)
v. Doc (docetaxel)
vi. TC (docetaxel, cyclophosphamide)
vii. TCH (docetaxel, carboplatin, trastuzumab)
5. Colorectal Cancer:
FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, irinotecan)
6. Esophageal and Gastric Cancers:
Docetaxel/cisplatin/fluorouracil
7. Head and Neck Squamous Cell Carcinoma
TPF (docetaxel, cisplatin, 5-fluorouracil)
8. Hodgkin Lymphoma:
i. Brentuximab vedotin + AVD (doxorubicin, vinblastine, dacarbazine)
ii. Escalated BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone)
9. Kidney Cancer:
Doxorubicin/gemcitabine
10. Non-Hodgkin's Lymphoma:
i. CHP (cyclophosphamide, doxorubicin, prednisone) + brentuximab vedotin
ii. Dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin)
iii. ICE (ifosfamide, carboplatin, etoposide)
iv. Dose-dense CHOP-14 (cyclophosphamide, doxorubicin, vincristine, prednisone) ± rituximab
v. MINE (mesna, ifosfamide, mitoxantrone, etoposide)
vi. DHAP (dexamethasone, cisplatin, cytarabine)
vii. ESHAP (etoposide, methylprednisolone, cisplatin, cytarabine (Ara-C))
viii. HyperCVAD ± rituximab (cyclophosphamide, vincristine, doxorubicin, dexamethasone ± rituximab)
ix. VAPEC-B (vincristine, doxorubicin, prednisolone, etoposide, cyclophosphamide, bleomycin)
11. Melanoma:
Dacarbazine-based combination with IL-2, interferon alpha (dacarbazine, cisplatin, vinblastine, IL-2, interferon alfa)
12. Multiple Myeloma:
i. VTD-PACE (dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide + bortezomib)
ii. DT-PACE (dexamethasone/thalidomide/cisplatin/doxorubicin/cyclophosphamide/etoposide)
13. Ovarian Cancer:
i. Topotecan
ii. Docetaxel
14. Soft Tissue Sarcoma:
i. MAID (mesna, doxorubicin, ifosfamide, dacarbazine)
ii. Doxorubicin
iii. Ifosfamide/doxorubicin
15. Small Cell Lung Cancer:
i. Top (topotecan)
ii. CAV (cyclophosphamide, doxorubicin, vincristine)
16. Testicular Cancer:
i. VelP (vinblastine, ifosfamide, cisplatin)
ii. VIP (etoposide, ifosfamide, cisplatin)
iii. TIP (paclitaxel, ifosfamide, cisplatin)
17. Gestational Trophoblastic Neoplasia:
i. EMA/CO (etoposide, methotrexate, dactinomycin/cyclophosphamide, vincristine)
ii. EMA/EP (etoposide, methotrexate, dactinomycin/etoposide, cisplatin)
iii. EP/EMA (etoposide, cisplatin/etoposide, methotrexate, dactinomycin)
iv. TP/TE (paclitaxel, cisplatin/paclitaxel, etoposide)
v. BEP (bleomycin, etoposide, cisplatin)
vi. VIP (etoposide, ifosfamide, cisplatin)
vii. ICE (ifosfamide, carboplatin, etoposide)
18. Wilms Tumor:
i. Regimen M (vincristine, dactinomycin, doxorubicin, cyclophosphamide, etoposide)
ii. Regimen I (vincristine, doxorubicin, cyclophosphamide, etoposide)
*Applies to chemotherapy regimens with or without monoclonal antibodies (e.g., trastuzumab, rituximab)
† This list is not comprehensive; there are other agents/regimens that have an intermediate/high risk for development of febrile neutropenia.
B. APPENDIX B: Selected Chemotherapy Regimens with an Incidence of Febrile Neutropenia of 10% to 19%*†
1. Occult Primary – Adenocarcinoma:
Gemcitabine/docetaxel
2. Breast Cancer:
i. Docetaxel
ii. CMF classic (cyclophosphamide, methotrexate, fluorouracil)
iii. CA (doxorubicin, cyclophosphamide) (60 mg/m2) (hospitalized)
iv. AC (doxorubicin, cyclophosphamide) + sequential docetaxel (taxane portion only)
v. AC + sequential docetaxel + trastuzumab
vi. A (doxorubicin) (75 mg/m2)
vii. AC (doxorubicin, cyclophosphamide)
viii. CapDoc (capecitabine, docetaxel)
ix. Paclitaxel every 21 days
3. Cervical Cancer:
i. Irinotecan
ii. Cisplatin/topotecan
iii. Paclitaxel/cisplatin
iv. Topotecan
4. Colorectal Cancer:
i. FL (fluorouracil, leucovorin)
ii. CPT-11 (irinotecan) (350 mg/m2 q 3 wk)
iii. FOLFOX (fluorouracil, leucovorin, oxaliplatin)
iv. FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, irinotecan)
5. Esophageal and Gastric Cancers:
i. Irinotecan/cisplatin
ii. Epirubicin/cisplatin/5-fluorouracil
iii. Epirubicin/cisplatin/capecitabine
6. Non-Hodgkin's Lymphomas:
i. EPOCH-IT chemotherapy
ii. GDP (gemcitabine, dexamethasone, cisplatin/carboplatin)
iii. GDP (gemcitabine, dexamethasone, cisplatin/carboplatin) + rituximab
iv. FMR (fludarabine, mitoxantrone, rituximab)
v. CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) including regimens with pegylated liposomal doxorubicin
vi. CHOP + rituximab (cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab) including regimens with pegylated liposomal doxorubicin
vii. Bendamustine
7. Non-Small Cell Lung Cancer:
i. Cisplatin/paclitaxel
ii. Cisplatin/vinorelbine
iii. Cisplatin/docetaxel
iv. Cisplatin/etoposide
v. Carboplatin/paclitaxel
vi. Docetaxel
8. Ovarian Cancer:
Carboplatin/docetaxel
9. Pancreatic Cancer:
FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, irinotecan)
10. Prostate Cancer:
Cabazitaxel
11. Small Cell Lung Cancer:
Etoposide/carboplatin
12. Testicular Cancer:
i. BEP (bleomycin, etoposide, cisplatin)
ii. Etoposide/cisplatin
13. Uterine Sarcoma:
Docetaxel
*Applies to chemotherapy regimens with or without monoclonal antibodies (e.g., trastuzumab, rituximab)
† This list is not comprehensive; there are other agents/regimens that have an intermediate/high risk for development of febrile neutropenia.
C. APPENDIX C: Patient Risk Factors*
1. Active infections, open wounds, or recent surgery
2. Age greater than or equal to 65 years
3. Bone marrow involvement by tumor producing cytopenias
4. Previous chemotherapy or radiation therapy
5. Poor nutritional status
6. Poor performance status
7. Previous episodes of FN
8. Other serious co-morbidities, including renal dysfunction, liver dysfunction, HIV infection, cardiovascular disease
9. Persistent neutropenia
*This list is not all-inclusive.
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
1. Rolvedon [package insert]. Irvine, CA: Spectrum Pharmaceuticals, Inc.; September 2022.
2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org Accessed June 20, 2023
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Growth Factors. Version 2.2023 https://www.nccn.org/professionals/physician_gls/pdf/growthfactors.pdf Accessed June 13, 2023.
4. Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of white blood cell growth factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33(28):3199-3212.
5. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Cell Transplantation. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf Accessed June 23, 2023.
6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hairy Cell Leukemia. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/hairy_cell.pdf Accessed June 19, 2023.
7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Gestational Trophoblastic Neoplasia. Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/gtn.pdf Accessed June 19, 2023.
8. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Wilms Tumor (Nephroblastoma). Version 1.2023. https://www.nccn.org/professionals/physician_gls/pdf/wilms_tumor.pdf Accessed June 19, 2023.
ORIGINAL EFFECTIVE DATE: 12/31/2022
MOST RECENT REVIEW DATE: 5/31/2024
ID_CHS
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