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Medical Policy: 05.01.19
Original Effective Date: June 2008
Reviewed:
Revised: October 2008
This policy applies to all products unless specific contract
limitations, exclusions or exceptions apply. Please refer to the member's coverage
manual for benefit availability. Managed care guidelines related to referral authorization,
and precertification of inpatient hospitalization, home health, home infusion and
hospice services apply.
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.
In February 2004, the United States Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for cetuximab for metastatic colorectal cancer; and, in March 2006, the FDA approved the BLA for cetuximab for squamous cell carcinoma of the head and neck.
Cetuximab is recommended in the National Comprehensive Cancer Network (NCCN) treatment guidelines for use in colorectal cancer as second-, third-, or fourth-line chemotherapy in combination with irinotecan for advanced or unresectable metastatic colon cancer, or as a single agent for patients who are intolerant to irinotecan. NCCN also recommends cetuximab for recurrent or unresectable head and neck cancers.
Policy:
Cetuximab may be considered medically necessary for the treatment of EGFR-expressing metastatic colorectal cancer for any of the following indications:
Effective January 1, 2009 KRAS mutation analysis will be required prior to treatment of EGFR-expressing metastatic colorectal cancer when cetuximab is used as a single agent in patients who are intolerant to irinotecan-based chemotherapy.
NOTE: Please see medical policy 02.04.20; KRAS Mutation Analysis in Metastatic 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 is considered investigational for all other indications including but not limited to:
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Procedure Codes and Billing
Guidelines:
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To report provider services, use appropriate CPT** codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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HCPCS code 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.
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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
Station 304
636 Grand Ave
Des Moines, Iowa 50309
*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.
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.
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