50242-0060-XX Avastin 100 MG/4ML SOLN (GENENTECH)
50242-0061-XX Avastin 400 MG/16ML SOLN (GENENTECH)
Bevacizumab is a recombinant humanized monoclonal IgG1 antibody which binds to human vascular endothelial growth factor (VEGF). VEGF normally interacts with receptors (Flt-1 and KDR) on the surface of endothelial cells and leads to endothelial cell proliferation and new blood vessel formation. By binding to VEGF, bevacizumab halts interaction with these receptors, resulting in reduction of microvascular growth and inhibition of metastatic disease progression.
Note: This policy does not address the use of bevacizumab for the treatment of disorders of the eye. Preauthorization is not needed for Avastin when used in the treatment of eye disorders.
Bevacizumab for the treatment of the following neoplastic conditions is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
AIDS-Related Kaposi Sarcoma
Central nervous system cancer
Malignant Pleural Mesothelioma
Non-small cell lung cancer
Renal cell carcinoma
Soft tissue sarcoma
Bevacizumab for the treatment of other conditions/diseases is considered investigational:
See also: Human Epidermal Receptor Type 2 (HER 2) Testing
Bevacizumab is considered medically appropriate if ALL of the of the following:
Individual has no recent history of hemorrhage or hemoptysis (the presence of blood in sputum)
Individual has not had a surgical procedure within the preceding 28 days and any surgical wound has fully healed
Diagnosis of ANY ONE of the following:
AIDS-Related Kaposi Sarcoma if ALL of the following:
Subsequent systemic therapy given with antiretroviral therapy (ART)
Relapsed or refractory disease
Disease is advanced cutaneous, oral, visceral, or nodal
Breast cancer that is recurrent or metastatic for treatment in combination with paclitaxel and diagnosed as invasive HER2-negative disease that is ANY ONE of the following:
Hormone receptor negative
Hormone receptor positive and refractory to endocrine therapy
Experiencing symptomatic visceral disease or visceral crisis
Central Nervous System Cancer, Primary, further diagnosed as ANY ONE of the following:
Adult intracranial / spinal ependymoma excluding subependymoma as single agent treatment for disease progression
Anaplastic Glioma, recurrent, OR Glioblastoma (also known as glioblastoma multiforme), recurrent, as a single agent or in combination with ANY ONE of the following:
Cervical cancer that is persistent, recurrent or metastatic as first-line therapy or second-line therapy (if not previously used as first-line) with paclitaxel and cisplatin or topotecan
Colorectal cancer that is ANY ONE of the following:
Used as first- or second-line therapy in combination with a fluoropyrimidine (e.g., 5-fluorouracil/5-FU or capecitabine) or irinotecan-based regimen
With disease progression on a first-line bevacizumab-containing regimen, used in combination with an irinotecan and/or oxaliplatin-based regimen (if not used first-line)
Malignant Pleural Mesothelioma if ALL of the following:
Individual has unresectable or metastatic disease
Used in combination with pemetrexed and cisplatin followed by single-agent maintenance therapy
Neurofibromatosis diagnosed as type 2 (NF2) exhibiting ALL of the following:
Bilateral progressive vestibular schwannomas
Progressive hearing loss
Nonsquamous non-small cell lung cancer (NSCLC) that is recurrent, unresectable, locally advanced or metastatic used as ANY ONE of the following:
First-line chemotherapy regimen in combination with cisplatin- or carboplatin-based regimens
Used for recurrent or metastatic disease in combination with carboplatin and paclitaxel/pemetrexed OR cisplatin and pemetrexed for ANY ONE of the following
Used as first-line therapy for genomic tumor aberration (e.g., EGFR, ALK, ROS1, BRAF and PD-L1) negative or unknown OR BRAF V600E-mutation positive
Used as subsequent therapy for genomic tumor aberration (e.g., EGFR, BRAF V600E, ALK, ROS1, PD-L1) positive and prior targeted therapy (See Genomic Aberration Targeted Therapies Chart below)
Continuation maintenance therapy if ALL of the following :
Bevacizumab must have been included in first-line chemotherapy regimen
ECOG performance status of 0-2
Disease has not progressed (achieved tumor response or stable disease) after first-line chemotherapy
Used as single agent OR in combination with pemetrexed if bevacizumab was previously used with a first-line pemetrexed/platinum chemotherapy regimen
Ovarian cancer diagnosed as epithelial ovarian, fallopian tube or primary peritoneal cancer that is persistent or recurrent and bevacizumab has not been used previously used as ANY ONE of the following:
If platinum sensitive, use bevacizumab in combination with ANY ONE of the following followed by bevacizumab as a single agent:
Carboplatin and gemcitabine
Carboplatin and paclitaxel
If platinum resistant, use in combination with ANY ONE of the following:
Pegylated liposomal doxorubicin
Ovarian cancer diagnosed as malignant sex cord-stromal tumors as a single agent in clinical relapse for stage II-IV disease
Renal cell carcinoma (RCC) (kidney cancer) that is metastatic or relapsed and first-line therapy if ANY ONE of the following:
Predominantly clear cell histology in combination with interferon alpha-2b
Predominantly non-clear cell histology ONLY as a single agent
Used in combination with erlotinib or everolimus for advanced papillary RCC including hereditary leiomyomyomatosis and renal cell cancer (HLRCC)
Soft tissue sarcoma further diagnosed as ANY ONE of the following:
Angiosarcoma for treatment as a single agent
Solitary Fibrous Tumor/Hemangiopericytoma for treatment in combination with temozolomide
Uterine neoplasms further diagnosed as endometrial carcinoma as single-agent therapy for disease that has progressed on prior cytotoxic chemotherapy
Genomic Aberration Targeted Therapies (not all inclusive)
Bevacizumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Tumor response is evident with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the agent, e.g., gastrointestinal perforation, surgical/wound healing complications, hemorrhage, arterial and venous thromboembolic events (ATE & VTE), uncontrolled hypertension, posterior reversible encephalopathy syndrome (PRES), nephrotic syndrome, severe infusion reactions, congestive heart failure (CHF) etc.
Additional requirements for diagnoses of ANY ONE of the following:
Metastatic colorectal cancer (additional renewal opportunity) - disease has progressed on a first-line bevacizumab-containing regimen, used in combination with an irinotecan and/or oxaliplatin-based regimen (if not used first line)
Malignant Pleural Mesothelioma - must be used as a single agent as maintenance therapy
Non-Squamous Non-Small Cell Lung Cancer continuation maintenance therapy if ALL of the following:
Bevacizumab must have been included in first- line chemotherapy
Individual has ECOG performance status of 0-2
Used as a single agent or with pemetrexed if bevacizumab previously used with a first-line pemetrexed /platinum chemotherapy regimen
Ovarian cancer, platinum sensitive disease or recurrence, for ANY ONE of the following:
Used as a single agent for maintenance therapy
In combination with chemotherapy for completion of initial therapy, up to 10 cycles total
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Colorectal Cancer||5 to 10 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks|
|NSCLC & Cervical Cancer||15 mg/kg every 3 weeks until disease progression or unacceptable toxicity.|
|Glioblastoma & Renal Cell Carcinoma||10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.|
|Malignant Pleural Mesothelioma||15 mg/kg every 3 weeks in combination with chemotherapy for up to 6 cycles followed by single agent use, at the same dose/frequency, until disease progression or unacceptable toxicity.|
15 mg/kg every 3 weeks for up to 8 cycles when used with paclitaxel or up to 10 cycles when used with gemcitabine; followed by single-agent bevacizumab 15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity
|All Other Oncology Indications||
5-10 mg/kg every 2 weeks OR 7.5-15 mg/kg every 3 weeks
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Click here to view DOSAGE LIMITS
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.
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, the express terms of the health plan will govern.
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).
No controlled studies were found in the published literature that validate the use of bevacizumab for the treatment or prevention of other conditions or diseases.
Anandan, S. & Bilodeau, C. C. Acoustic neuroma. In Ferri, F. F.(Ed.), Ferri’s Clinical Advisor 2013 (1st ed. sec.1). Philadelphia, PA: Mosby, Elsevier.
Lexi-Comp Online. (2018). AHFS DI. Bevacizumab. Retrieved February 7, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, February). Bevacizumab. Retrieved February 7, 2018 from MICRODEX Healthcare Series.
Mink. J. W. (2011). Congenital, developmental, and neurocutaneous disorders. In Goldman, L. & Schafer, A. I. (Eds.), Goldman’s Cecil medicine (ch. 426). Philadelphia, PA: Saunders, Elsevier.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Bevacizumab. Retrieved February 7, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, December). Center for Drug Evaluation and Research. Avastin® (bevacizumab) solution for intravenous infusion. Retrieved February 7, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125085s319lbl.pdf.
ORIGINAL EFFECTIVE DATE: 2/1/2005
MOST RECENT REVIEW DATE: 5/8/2018
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.
Maximum billable units per dose and over time by indication as a Medical Benefit