Cetuximab
DESCRIPTION
Cetuximab is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab binds to the EGFR on both normal and tumor cells and competitively inhibits the binding of epidermal growth factor and other ligands, such as transforming growth factor-alpha. Binding cetuximab to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production.
An example of a preparation of cetuximab is Erbitux®.
REFER TO DECISION SUPPORT TREE
POLICY
Cetuximab for the treatment of metastatic colorectal carcinoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cetuximab for the treatment of malignant tumors of the head and neck is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cetuximab for the treatment of other conditions or diseases is considered investigational.
MEDICAL APPROPRIATENESS
Cetuximab for the treatment of metastatic colorectal carcinoma is considered medically appropriate if any of the following criteria are met:
The agent is used in combination with irinotecan (e.g., Camptosar®) for individuals who are refractory to irinotecan based chemotherapy; or
As a single agent for individuals who are intolerant to irinotecan based chemotherapy; or
As a single agent for individuals who have failed both irinotecan based and oxaliplatin based regimens (e.g., Eloxatin®).
Cetuximab for the treatment of malignant tumors of the head and neck is considered medically appropriate if any of the following criteria are met:
The agent is used in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck; or
The agent is used as a single agent for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
There is insufficient evidence supporting the use of cetuximab for the treatment of other conditions/diseases.
SOURCES
Chemotherapy for esophageal, gastric and colorectal cancers. (2006, August). Treatment Guidelines from The Medical Letter, 4 (Issue 48), 55-60.
Complete Guide to Medicare Coverage Issues [Computer software]. (2007, July). Anticancer chemotherapy for colorectal cancer (NCD 110.17, p. 2-56 -2-57). St. Anthony Publishing.
Cunningham, D., Humblet, Y., Siena, S., Khayat, D., Bleiberg, H., Santoro, A., et al. (2004). Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. The New England Journal of Medicine, 351 (4), 337-345.
Jonker, D. J., O’Callaghan, C. J., Karapetis, C., Zalcberg, J. R., Tu, D., Au, H.J. et. al. (2007, November). Cetuximab for the treatment of colorectal cancer. The New England Journal of Medicine, 357 (20), 2040-2048.
Lexi-Comp Online. (2007). AHFS DI. Cetuximab. Retrieved October 25, 2007 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. DrugDex Drug Evaluations. (2007). Cetuximab. Retrieved October 25, 2007 from MICROMEDEX Healthcare Series.
Saltz, L. B., Meropol, N. J., Loehrer, P. J. Sr., Needle, M. N., Kopit, J., & Mayer, R. J. (2004). Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. Journal of Clinical Oncology, 22 (7), 1201-1208.
U. S. Food and Drug Administration. (2007, August). Center for Drug Evaluation and Research. Approval Letter. BL 125084/103. Retrieved October 25, 2007 from http://www.fda.gov/cder/foi/appletter/2007/125084s103ltl.pdf.
U. S. Food and Drug Administration. (2007, August). Center for Drug Evaluation and Research. Erbitux (cetuximab). Retrieved October 25, 2007 from http://www.fda.gov/cder/foi/label/2007/125084s103lbl.pdf.
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EFFECTIVE DATE |
12/14/2007 |
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ID_BT
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.
Pharmaceutical Decision Support Tree
Cetuximab (Erbitux®)
Does the individual have squamous cell carcinoma of the head and neck?
If yes, go to question #2
If no, go to question #4
Is the agent to be used in combination with radiation therapy for locally or regionally advanced squamous cell carcinoma?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Is the agent to be used as a single agent for recurrent or metastatic squamous cell carcinoma that has been refractory to platinum-based therapy?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have metastatic colorectal carcinoma?
If yes, go to question #5
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is cetuximab to be used in combination with irinotecan for individuals who are refractory to irinotecan based chemotherapy?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #6
Does the individual show evidence they are intolerant to irinotecan based chemotherapy?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #7
Does the individual show evidence they have failed both irinotecan based and oxaliplatin based regimens (e.g., Eloxatin®)?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.