Medical Policy

Effective Date:12/02/2009 Title:Erbitux (Cetuximab)
Revision Date:10/01/2013 Document:BI256:00
CPT Code(s):J9055
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Erbitux (cetuximab) requires preauthorization.

2)    Erbitux is an intravenous medication used to treat advanced head and neck or colon cancers.

3)    It has been shown that individuals with a certain gene mutation in colon cancers do not respond to Erbitux.

Medical Statement

1)    Erbitux (Cetuximab) is eligible for coverage if meeting the following criteria:

a)    Cancer of the head and neck.

b)    Non small cell lung cancer

i)       Metastatic or recurrent and

ii)     Epidermal Growth Factor Receptor (EGFR) positive.

c)     Colon Cancer

i)       Metastatic disease and

ii)     Documented presence of only the wild-type KRAS gene. See BI129 Tumor markers.

Codes Used In This BI:


J9055 - Cetuximab injection


1)    Erbitux is not eligible for benefits in members who have shown colon cancer progression after a course of therapy with Vectibix (panitumumab).

2)    Erbitux is considered experimental/investigational for other tumors.

  1. U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research. Erbitux (cetuximab) Information [website]. Rockville, MD: FDA; February 12, 2004.
  2. Coutinho AK, Rocha Lima CM. Metastatic colorectal cancer: Systemic treatment in the new millennium. Cancer Control. 2003;10(3):224-238.
  3. Gill S, Thomas RR, Goldberg RM. Review article: Colorectal cancer chemotherapy. Aliment Pharmacol Ther. 2003;18(7):683-692.
  4. Kim ES, Vokes EE, Kies MS. Cetuximab in cancers of the lung and head & neck. Semin Oncol. 2004;31(1 Suppl 1):61-67. 
  5. Khuri FR, Jain SR. Novel agents and incremental advances in the treatment of head and neck cancer. Semin Oncol. 2004;31(2 Suppl 4):3-10.
  6. Caponigro F, Ionna F, Comella G. New cytotoxic and molecular-targeted therapies of head and neck tumors. Curr Opin Oncol. 2004;16(3):225-230.
  7. Caponigro F. Rationale and clinical validation of epidermal growth factor receptor as a target in the treatment of head and neck cancer. Anticancer Drugs. 2004;15(4):311-320.
  8. Ciardiello F, De Vita F, Orditura M, Tortora G. The role of EGFR inhibitors in nonsmall cell lung cancer. Curr Opin Oncol. 2004;16(2):130-135.
  9. Bonner JA, Giralt J, Harari PM, et al, Cetuximab prolongs survival in patients with locoregionally advanced squamous cell carcinoma of head and neck: A phase III study of high dose radiation therapy with or without cetuximab [abstract]. J Clin Oncol, 2004;22(14S): 5507.
  10. Posner MR, Wirth LJ. Cetuximab and radiotherapy for head and neck cancer. N Engl J Med. 2006;354(6):634-636.
  11. Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006;354(6):567-578.
  12. Wild R, Fager K, Flefleh C, et al. Cetuximab preclinical antitumor activity (monotherapy and combination based) is not predicted by relative total or activated epidermal growth factor receptor tumor expression levels. Mol Cancer Ther. 2006;5(1):104-113.
  13. National Horizon Scanning Centre (NHSC). Cetuximab (Erbitux) for metastatic colorectal cancer: Horizon scanning technology briefing. Birmingham, UK: NHSC; 2006.
  14. National Horizon Scanning Centre (NHSC). Cetuximab (Erbitux) for non-small cell lung cancer: Horizon scanning technology briefing. Birmingham, UK: NHSC; 2006.
  15. Pichon Riviere A, Augustovski F, Alcaraz A, et al. Cetuximab for the management of advanced colorectal cancer. Report IRR No. 57. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2005.
  16. Hanna N, Lilenbaum R, Ansari R, et al. Phase II trial of cetuximab in patients with previously treated non-small-cell lung cancer. J Clin Oncol. 2006;24(33):5253-5258.
  17. Azim HA Jr, Ganti AK. Targeted therapy in advanced non-small cell lung cancer (NSCLC): Where do we stand? Cancer Treat Rev. 2006;32(8):630-636.
  18. Maione P, Gridelli C, Troiani T, Ciardiello F. Combining targeted therapies and drugs with multiple targets in the treatment of NSCLC. Oncologist. 2006;11(3):274-284.
  19. Van Cutsem E, Nowacki M, Lang I, et al.  Randomized phase III study of irinotecan and 5-FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): The CRYSTAL trial. 2007 ASCO Annual Meeting Proceedings Part I. J Clin Oncol. 2007;25(18S): LBA4000.
  20. Philip PA, Benedetti J, Fenoglio-Preiser C, et al.  Phase III study of gemcitabine [G] plus cetuximab [C] versus gemcitabine in patients [pts] with locally advanced or metastatic pancreatic adenocarcinoma [PC]: SWOG S0205 study. 2007 ASCO Annual Meeting Proceedings Part I. J Clin Oncol. 2007:25(18S): LBA4509.
  21. Tappenden P, Jones R, Paisley S, Carroll C. Systematic review and economic evaluation of bevacizumab and cetuximab for the treatment of metastatic colorectal cancer. Health Technol Assess. 2007;11(12):1-146.
  22. National Institute for Health and Clinical Excellence (NICE). Bevacizumab and cetuximab for the treatment of metastatic colorectal cancer. Technology Appraisal Guidance 118. London, UK: NICE; 2007.
  23. Pinto C, Di Fabio F, Siena S, et al. Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). Ann Oncol. 2007;18(3):510-517.
  24. Morgensztern D, Govindan R. Is there a role for cetuximab in non small cell lung cancer? Clin Cancer Res. 2007;13(15 Pt 2):s4602-s4605.
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  27. Safran H, Suntharalingam M, Dipetrillo T, et al. Cetuximab with concurrent chemoradiation for esophagogastric cancer: Assessment of toxicity. Int J Radiat Oncol Biol Phys. 2008;70(2):391-395.
  28. Rivera F, Vega-Villegas ME, López-Brea MF. Cetuximab, its clinical use and future perspectives. Anticancer Drugs. 2008;19(2):99-113.
  29. National Comprehensive Cancer Network (NCCN). Non-small cell lung cancer. NCCN Clinical Practice Guidelines in Oncology, v.2.2009. Fort Washington, PA: NCCN; 2009.
  30. National Comprehensive Cancer Network (NCCN). Colon Cancer. NCCN Clinical Practice Guidelines in Oncology, v.3.2009. Fort Washington, PA: NCCN; 2009
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.