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Avastin® (bevacizumab) for Non-Ophthalmologic Conditions*

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 05.01.14 
Original Effective Date: September 2006 
Reviewed: August 2015 
Revised: August 2015 


Benefit Application
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.


Description: 

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

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Prior Approval: 

 

Prior approval is required. Submit a prior approval/treatment request now .


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Policy: 

I. Bevacizumab is considered medically necessary for any of the following indications:

  • Advanced or metastatic colorectal cancer
  • Anaplastic gliomas
  • Angiosarcoma
  • Cervical cancer
  • Endometrial cancer
  • Glioblastoma
  • Hemangiopericytoma
  • 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

 

 

CLIINICAL RATIONALE

 

The Avastin (bevacizumab) drug policy recognizes the FDA approved and NCCN compendia supported uses (2A recommendation or better) of bevacizumab as medically necesary.

 

Breast Cancer

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.





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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

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Selected References: 

  1. Avastin®. [package insert]. South San Francisco, CA: Genentech, Inc; March 2013November 2014.
  2. 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.
  3. 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.
  4. 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.
  5. 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 

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Policy History: 

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


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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.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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