BlueCross BlueShield of Tennessee Medical Policy Manual
Cetuximab (Erbitux®)
MPORTANT 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
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Erbitux is indicated:
K-Ras Wild-type, EGFR-expressing Colorectal Cancer (CRC)
Erbitux is indicated for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) as determined by an FDA-approved test:
Limitations of Use:
Erbitux is not indicated for treatment of Ras-mutant colorectal cancer or when the results of the Ras mutation tests are unknown.
BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
Erbitux is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
COVERAGE CRITERIA
Colorectal Cancer
Authorization of 6 months may be granted for treatment of colorectal cancer, including appendiceal adenocarcinoma and anal adenocarcinoma, for unresectable/inoperable, advanced, or metastatic disease and the member has not previously experienced clinical failure on panitumumab when either of the following criteria are met:
Squamous Cell Carcinoma of the Head and Neck
Authorization of 6 months may be granted for treatment of squamous cell carcinoma of the head and neck when any of the following criteria is met:
Occult Primary Head and Neck Cancer
Authorization of 6 months may be granted as a single agent for treatment of occult primary head and neck cancer for chemoradiation.
Penile Cancer
Authorization of 6 months may be granted as a single agent for subsequent treatment of metastatic / recurrent penile cancer.
Squamous Cell Skin Cancer
Authorization of 6 months may be granted as a single agent or in combination with carboplatin and paclitaxel for treatment of squamous cell skin cancer in unresectable/inoperable/incompletely resected, locally advanced, regional, recurrent, or distant metastatic disease.
Non-Small Cell Lung Cancer (NSCLC)
Authorization of 6 months may be granted for subsequent treatment of recurrent, advanced or metastatic NSCLC when all of the following criteria are met:
CONTINUATION OF THERAPY
Authorization of 6 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 |
|
Erbitux (Cetuximab) |
Colorectal Cancer, including Appendiceal Adenocarcinoma and Anal Adenocarcinoma |
Route of Administration: Intravenous 500mg/m² every 2 weeks
Initial: 400mg/m² once Maintenance: 250mg/m² every week |
|
Erbitux Cetuximab) |
Non-Small Cell Lung Cancer (NSCLC) |
Route of Administration: Intravenous 500mg/m² every 2 weeks |
|
Erbitux (Cetuximab) |
Penile Cancer |
Route of Administration: Intravenous Initial: 400mg/m² once Maintenance: 250mg/m² every week |
|
Erbitux (Cetuximab) |
Squamous Cell Carcinoma of the Head and Neck |
Route of Administration: Intravenous 500mg/m² every 2 weeks
Initial: 400mg/m² once Maintenance: 250mg/m² every week |
|
Erbitux (Cetuximab) |
Squamous Cell Skin Cancer |
Route of Administration: Intravenous Initial: 400mg/m² once Maintenance: 250mg/m² every week |
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: 3/10/2005
MOST RECENT REVIEW DATE: 4/30/2025
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.
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