Medical Policy: 05.01.14
Original Effective Date: September 2006
Reviewed: August 2015
Revised: August 2015
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
The intent of the Avastin® (bevacizumab) drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies. Bevacizumab is a recombinant humanized IgG1 monoclonal antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF), which plays a significant role in tumor angiogenesis, a process necessary for tumor growth and metastasis. Bevacizumab is administered intravenously.
Bevacizumab is approved by the Food and Drug Administration (FDA) for the following indications:
In combination with intravenous 5-fluorouracil (5-FU)-based chemotherapy for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.
In combination with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment of patients with metastatic carcinoma of the colon or rectum who have progressed on a first-line Avastin®-containing regimen.
In combination with carboplatin and paclitaxel for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.
As single agent treatment for patients with glioblastoma with progressive disease following prior therapy.
In combination with interferon alfa for treatment of patients with metastatic renal cell carcinoma
In combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for the treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who received no more than two chemotherapy regimens
In combination with paclitaxel, doxorubicin liposomal, or topotecan for treatment of platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who received no more than 2 prior chemotherapy regimens
Prior approval is required. Submit a prior approval/treatment request now .
I. Bevacizumab is considered medically necessary for any of the following indications:
- Advanced or metastatic colorectal cancer
- Anaplastic gliomas
- Cervical cancer
- Endometrial cancer
- Malignant Pleural Mesothelioma
- Metastatic renal cell cancer
- Non-squamous non-small cell lung (NSCLC) cancer
- Progressive or recurrent adult intracranial ependymoma
- Solitary fibrous tumors
II. Bevacizumab is considered medically necessary for the treatment of breast cancer in combination with paclitaxel when ONE of the following criteria are met:
- Patient has recurrent or metastatic disease human epidermal growth factor receptor 2 (HER2)- negative disease with symptomatic visceral disease or visceral crisis; OR
- Patient has recurrent or metastatic HER2-negative disease that is either hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory
III. Bevacizumab is considered medically necessary for the treatment of ovarian cancer when ONE of the following criteria are met:
Patient has an ovarian stromal tumor (stage II-IV granulose cell tumor) for which bevacizumab is being used following clinical relapse; OR
Patient has platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in which bevacizumab has not been previously received, and is being used in combination with liposomal doxorubicin, paclitaxel, or topotecan; OR
Patient has persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, in which brevacizumab has not been previously received, and is being used as a single agent
Approval will be for lifetime for patients who meet any of the afore-mentioned medical necessity criteria.
IV. Bevacizumab is considered not medically necessary for patients who do not meet the criteria set forth above.
Please refer to the following document for information regarding coverage of this drug for ophthalmologic conditions: 09.03.12 Vascular Endothelial Growth Factor (VEGF) Inhibitors for Ophthalmic Use
The Avastin (bevacizumab) drug policy recognizes the FDA approved and NCCN compendia supported uses (2A recommendation or better) of bevacizumab as medically necesary.
In February 2008, the FDA announced the accelerated approval for Avastin (bevacizumab) in combination with paclitaxel for the treatment of metastatic HER2-negative breast cancer who haven't yet received chemotherapy for metastatic breast cancer. In November 2011, the FDA revolked the breast cancer indication from Avastin due to the lack of clinical benefit compared to the serious safety risks.
The 2015 National Comprehensive Cancer Network (NCCN) practice guideline lists the off-label use of bevacizumab in combination with paclitaxel as a treatment for recurrent or mestastatic HER2-negative breast cancer as a 2A recommendation. This recommendations is based on randomized clinical trials in metastatic breast cancer that document that the addition of bevacizumab to some first- or second-line chemotherapy agents modestly improves time to progression and response rates but does not improve overall survival. The time-to-progression impact may vary among cytoxic agents and appears greatest with bevacizumab in combination with weekly paclitaxel.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- J9035 injection, bevacizumab, 10 mg
- Avastin®. [package insert]. South San Francisco, CA: Genentech, Inc; March 2013November 2014.
- The NCCN Drugs and Biologics Compendium. 2015 National Comprehensive Cancer Network. (NCCN Compendium™). Avastin (bevacizumab). Available at: http://www.nccn.org./professionals/drug_compendium/matrixgenerator/matrix.aspx?aid=1. Accessed March July 1812, 2015.
- National Comprehensive Cancer Netowrk. NCCN glinical practice guidelines in oncology: breast cancer. Version 2.2015. http://nccn,org/professionals/physician_gls/pdf/breast.pdf. Accessed July 28, 2015.
- National Comprehensive Cancer Netowrk. NCCN glinical practice guidelines in oncology: ovarian cancer. Version 1.2015. http://nccn,org/professionals/physician_gls/pdf/breast.pdf. Accessed July 28, 2015.
- U.S. Food and Drug Administration; “FDA begins process to remove breast cancer indication from Avastin label”. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm237172.html
Date Reason Action
October 2010 Annual review Policy revised
October 2011 Annual review Policy renewed
October 2012 Annual review Policy revised
January 2013 Interim review Policy revised
August 2013 Annual review Policy revised
August 2014 Annual review Policy revised
May 2015 Interim review Policy revised
August 2015 Annual review Policy revised
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.