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Medical Policy: 05.01.19
Original Effective Date: June 2008
Reviewed: April 2011
Revised: April 2011
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:
Cetuximab, manufactured by ImClone Systems Incorporated and distributed by Bristol-Myers Squibb Company under the trade name Erbitux®, is in the class of signal transduction inhibitors. It is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR). Cetuximab targets the protein EGFR on the surface of cancer cells and interferes with their growth. 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.
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Prior Approval:
Prior approval is recommended. Submit a prior approval/treatment request now. ( 74KB)
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Policy:
Cetuximab may be considered medically necessary for the treatment of EGFR-expressing metastatic colorectal cancer for the following indications:
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In combination with irinotecan for patients who are refractory to irinotecan-based chemotherapy; OR
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As a single agent in patients who are intolerant to irinotecan-based chemotherapy; AND
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KRAS mutation analysis has demonstrated the tumor expresses the wild-type KRAS gene.
NOTE: KRAS mutation analysis is required prior to treatment of EGFR-expressing metastatic colorectal cancer whether cetuximab is used as in combination therapy or as a single agent. Please see medical policy 02.04.20; KRAS Mutation Analysis in Metastic Colorectal Cancer.
Cetuximab may be considered medically necessary for the treatment of squamous cell carcinoma of the head and neck for any of the following indications:
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Used in combination with radiation therapy for locally or regionally advanced disease
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Used as a single agent for recurrent or metastatic disease in which platinum-based therapy has failed
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Used as a single agent or in combination with cisplatin or carboplatin with or without fluorouracil and with or without radiation therapy for the following
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Unresectable locoregional recurrence or second primary in patients who have received prior radiation therapy
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Resectable locoregional recurrence in patients who have not received prior radiation therapy
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Distant metastases
Cetuximab may be considered medically necessary for the treatment of non-small cell lung cancer for the following indications:
- First-line therapy for recurrence or metastasis in combination with vinorelbine and cisplatin in patients with performance status 0-2
- Single-agent continuation maintenance therapy if given first line with chemotherapy for recurrence or metastasis in patients with performance status 0-2 who achieve tumor response or stable disease following first-line chemotherapy
Cetuximab is considered investigational for all other indications including but not limited to:
Cetuximab is considered investigational when used in persons who have previously been treated with panitumumab.
Cetuximab is considered investigational when used in the adjuvant setting for stage II or III colon cancer.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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HCPCS J9055 Injection, cetuximab, 10 mg
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Selected References:
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Jonker DJ, O’Callaghan CJ, Karapetis C et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007 Nov 15; 357(20):2040-8.
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Saltz LB, Lenz HJ, Kindler HL et al. Randomized phase II trial of cetuximab, bevacizumab, and irinotecan compared to cetuximab and bevacizumab alone in irinotecan-refractory colorectal cancer: the BOND-2 study. J Clin Oncol 2007 Oct 10; 25(29):4557-61.
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Jean GW, Shah SR. Epidermal growth factor receptor monoclonal antibodies for the treatment of metastatic colorectal cancer. Pharmacotherapy. 2008 Jun; 28(6):742-54.
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Baselga J, Trigo JM, Bourhis J et al. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol 2005Aug 20;23(24):5568-77.
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Burtness B, Goldwasser MA, Flood W et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol 2005 Dec 1;23(34):8646-8654.
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Vermorken JB, Mesia R, Rivera F et al. Platinum-Based Chemotherapy plus Cetuximab in Head and Neck Cancer. N Engl J Med 2008;359:1116-27.
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De Roock W, Piessevaux H, De Schutter J et al. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol. 2008 Mar;19(3):508-15. [E-pub 2007 Nov 12].
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Lievre A, Bachet JB, Boige V et al. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol 2008 Jan 20;26(3):374-9.
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Karapetis CS, Khambata-Ford S, Jonker DJ et al. K-ras Mutations and Benefit from Cetuximab in Advanced Colorectal Cancer. N Engl J Med 2008 Oct 23;359 (17):1757-65.
- Hecht JR, Mitchell E, Chidiac T et al. A randomized phase IIIB trial of chemotherapy, bevacizumab, and panitumumab comared with chemotherapy and bevacizumab alone for metastatic colorectal cancer. J Clin Oncol. 2009; 27:672-80.
- Pirker R, Pereira JR, Szczesna A et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 2009;373:1525-31.
- Chen P, Wang L, Liu B et al. EGFR_targeted therapies combined with chemotherapy for treating advanced non-small-cell lung cancer: a meta-analysis. Eur J Clin Pharmacol (2011);67:235-43.
- Azzoli CG, Baker Jr S, Temin S et al. American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer. J Clin Oncol 2009 Dec 20;27(36):6251-66.
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Policy History:
Date Reason Action
April 2011 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 © 2010 American Medical Association. All Rights Reserved.
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