Highmark Commercial Medical Policy - Pennsylvania
Medical Policy: I-100-004
Topic: Cetuximab (Erbitux)
Section: Injections
Effective Date: May 28, 2018
Issue Date: May 28, 2018
Last Reviewed: January 2018

Cetuximab (Erbitux®) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab is composed of the Fv regions of a murine and-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa. Cetuximab is produced in mammalian (murine myeloma) cell culture.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member’s benefit plan.

Food and Drug Administration (FDA)

Cetuximab (Erbitux) may be considered medically necessary for the following conditions:

Head and Neck Cancer

Colorectal Cancer

K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by FDA-approved tests:

Procedure Codes
J9055


National Comprehensive Cancer Network (NCCN)

Cetuximab (Erbitux®) may be considered medically necessary for the following conditions:

Colon Cancer

Squamous Cell Skin Cancer

Head and Neck Cancers - Cancer of the Glottic Larynx

Head and Neck Cancers - Cancer of the Hypopharynx

Head and Neck Cancers - Cancer of the Lip

Head and Neck Cancers - Cancer of the Nasopharynx

Head and Neck Cancers - Cancer of the Oropharynx

Head and Neck Cancers - Cancer of the Supraglottic Larynx

Head and Neck Cancers - Ethmoid Sinus Tumors

Head and Neck Cancers - Maxillary Sinus Tumors

Head and Neck Cancers - Occult Primary

Head and Neck Cancers - Advanced, Recurrent, Persistent

Non-Melanoma Skin Cancers - Basal Cell and Squamous Cell Skin Cancers

Non-Small Cell Lung Cancer (NSCLC)

Penile Cancer

Rectal Cancer

The use of cetuximab (Erbitux) for all other indications is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of cetuximab (Erbitux) for any indications other than those listed in this medical policy. 

Procedure Codes
J9055


NOTE: Dosage recommendations per the FDA label.



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The use of Cetuximab (Erbitux) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances including, but not limited to the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

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Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer: If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.