BlueCross BlueShield of Tennessee Medical Policy Manual
Bevacizumab Products (Avastin®; Mvasi® ; Zirabev™; Alymsys®; Vegzelma™; Avzivi®)
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
Metastatic Colorectal Cancer (mCRC)
First-Line Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Avastin, Alymsys, Avzivi, Mvasi, Vegzelma or Zirabev, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer.
Recurrent Glioblastoma (RGM)
Avastin, Alymsys, Avzivi, Mvasi, Vegzelma or Zirabev, is indicated for the treatment of recurrent glioblastoma in adults.
Metastatic Renal Cell Carcinoma (mRCC)
Avastin, Alymsys, Avzivi, Mvasi, Vegzelma or Zirabev, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma.
Persistent, Recurrent, or Metastatic Cervical Cancer
Avastin, Alymsys, Avzivi, Mvasi, Vegzelma or Zirabev, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Hepatocellular Carcinoma
Avastin, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
COVERAGE CRITERIA
Ophthalmic Disorders
Authorization of 6 months may be granted for treatment of the following retinal disorders:
Colorectal Cancer (CRC)
Authorization of 12 months may be granted for treatment of colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma.
Small Bowel Adenocarcinoma
Authorization of 12 months may be granted for treatment of small bowel adenocarcinoma.
Ampullary Adenocarcinoma
Authorization of 12 months may be granted for treatment of intestinal-type ampullary adenocarcinoma that is progressive, unresectable, or metastatic.
Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for treatment of recurrent, unresectable, advanced, or metastatic non-squamous NSCLC.
CNS Cancer
Authorization of 12 months may be granted for treatment of the following types of CNS cancer:
Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
Authorization of 12 months may be granted for treatment of epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and malignant sex cord stromal tumors.
Uterine Neoplasms/Endometrial Carcinoma
Authorization of 12 months may be granted for treatment of progressive, persistent, recurrent, or metastatic uterine neoplasms or endometrial carcinoma.
Cervical Cancer
Authorization of 12 months may be granted for treatment of persistent, recurrent, or metastatic cervical cancer.
Vaginal Cancer
Authorization of 12 months may be granted for treatment of recurrent or metastatic vaginal cancer.
Renal Cell Carcinoma
Authorization of 12 months may be granted for treatment of relapsed or stage IV renal cell carcinoma.
Soft Tissue Sarcoma
Authorization of 12 months may be granted for treatment of angiosarcoma, as single agent therapy.
Authorization of 12 months may be granted for treatment of solitary fibrous tumor or hemangiopericytoma, in combination with temozolomide.
Mesothelioma
Authorization of 12 months may be granted for treatment of pleural mesothelioma, peritoneal mesothelioma, pericardial mesothelioma, or tunica vaginalis testis mesothelioma when any of the following criteria are met:
Authorization of 12 months may be granted for treatment of peritoneal mesothelioma, pericardial mesothelioma, or tunica vaginalis testis mesothelioma when used in combination with atezolizumab as subsequent therapy.
Vulvar Carcinoma
Authorization of 12 months may be granted for treatment of advanced, recurrent, or metastatic vulvar carcinoma, including squamous cell carcinoma and adenocarcinoma.
Hepatocellular Carcinoma
Authorization of 12 months may be granted for treatment of unresectable or extrahepatic/ metastatic hepatocellular carcinoma, when the requested medication will be used as initial treatment in combination with atezolizumab.
Authorization of 12 months may be granted for adjuvant treatment of operable hepatocellular carcinoma, when the member is at a high risk of recurrence and the requested medication will be used in combination with atezolizumab.
CONTINUATION OF THERAPY
Ophthalmic Disorders
For ophthalmic disorders, authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when the member has demonstrated a positive clinical response to therapy (e.g., improvement or maintenance in best corrected visual acuity [BCVA] or visual field, or a reduction in the rate of vision decline or the risk of more severe vision loss).
All Other Indications
For all other indications, authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Ampullary Adenocarcinoma |
Route of Administration: Intravenous 5mg/kg every 2 weeks 7.5mg/kg every 3 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Colorectal Cancer, including Appendiceal Adenocarcinoma and Anal Adenocarcinoma |
Route of Administration: Intravenous 10mg/kg every 2 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Breast Cancer |
Route of Administration: Intravenous 10mg/kg every 2 weeks 15mg/kg every 3 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
CNS Cancer, including Glioblastoma |
Route of Administration: Intravenous 10mg/kg every 2 weeks 15mg/kg every 3 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd)
|
Cervical Cancer, Hepatocellular Carcinoma, Malignant Pleural Mesothelioma, Malignant Peritoneal Mesothelioma, Pericardial Mesothelioma, or Tunica Vaginalis Testis Mesothelioma, Non-Small Cell Lung Cancer, Soft Tissue Sarcoma: Angiosarcoma, Uterine Neoplasms -Endometrial Carcinoma, Vulvar Carcinoma |
Route of Administration: Intravenous 15mg/kg every 3 weeks |
Zirabev (Bevacizumab-bvzr) |
Cervical Cancer, Hepatocellular Carcinoma, Malignant Pleural Mesothelioma, Malignant Peritoneal Mesothelioma, Pericardial Mesothelioma, or Tunica Vaginalis Testis Mesothelioma, Non-Small Cell Lung Cancer |
Route of Administration: Intravenous 15mg/kg every 3 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Diabetic Macular Edema, Proliferative Diabetic Retinopathy, Neovascular Glaucoma (Adjunct) |
Route of Administration: Intravitreal ≥18 Year(s) 1.25mg in the affected eye(s) every 4 weeks |
Avastin (Bevacizumab)
|
Macular Edema following Retinal Vein Occlusion |
Route of Administration: Intravitreal ≥18 Year(s) 1.25mg in the affected eye(s) once and repeat at 1 to 3 month intervals |
Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Macular Edema following Retinal Vein Occlusion |
Route of Administration: Intravitreal ≥18 Year(s) 1.25mg in the affected eye(s) once and repeat at 1 to 3 month intervals |
|
Neovascular (wet) Age-Related Macular Degeneration (AMD), Choroidal Neovasculization |
Route of Administration: Intravitreal ≥18 Year(s) 1.25mg in the affected eye(s) every 4 weeks 2.5mg in the affected eye(s) every 4 weeks for 3 doses |
Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Neovascular (wet) Age-Related Macular Degeneration (AMD), Choroidal Neovasculization |
Route of Administration: Intravitreal ≥18 Years 1.25mg in the affected eye(s) every 4 weeks 2.5mg in the affected eye(s) every 4 weeks for 3 doses |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Ovarian, Fallopian, Primary Peritoneal Cancer |
Route of Administration: Intravenous 10mg/kg every 2 weeks 15mg/kg every 3 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Polypoidal Choroidal Vasculopathy |
Route of Administration: Intravitreal 2.5mg in the affected eye(s); frequency should not be more frequent than every 4 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Renal Cell Carcinoma |
Route of Administration: Intravenous 10mg/kg every 2 weeks
|
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Retinopathy of Prematurity |
Route of Administration: Intravitreal <18 Year(s) 0.625mg in the affected eye(s) for 1 dose |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) Zirabev (Bevacizumab-bvzr) |
Small Bowel Adenocarcinoma |
Route of Administration: Intravenous 5mg/kg every 2 weeks 7.5mg/kg every 3 weeks |
Avastin (Bevacizumab) Alymsys (Bevacizumab-maly) Mvasi (Bevacizumab-awwb) Vegzelma (Bevacizumab-adcd) |
Soft Tissue Sarcoma: Solitary Fibrous Tumor |
Route of Administration: Intravenous 5mg/kg every 2 weeks |
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: 2/1/2005
MOST RECENT REVIEW DATE: 7/31/2025
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.
This document has been classified as public information.