L29097

 

CETUXIMAB (ERBITUX®)

 

07/06/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Cetuximab is FDA approved for injection for the following indications:

 

Colorectal Cancer

• K-Ras mutation-negative (wild-type), EGFR-expressing, metastatic colorectal cancer as determined by FDA-approved tests. Limitation of Use: Erbitux is not indicated for treatment of K-Ras mutation-positive colorectal cancer.

• Cetuximab is indicated for use in combination with FOLFIRI for first-line treatment (irinotecan, 5-fluorouracil, leucovorin) with K-ras mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use. FDA also approved the Therascreen KRAS RGQ PCR Kit (QIAGEN Manchester, Ltd) concurrent with this cetuximab approval.

• Used in combination with irinotecan, cetuximab is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy.

• Administered as a single agent, cetuximab is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma after failure of both irinotecan and oxaliplatin-based regimens or in patients who are intolerant to irinotecan-based chemotherapy.

• Medicare considers cetuximab (Erbitux) medically necessary for treatment of beneficiaries with metastatic colorectal cancer and considers analysis of K-ras (KRAS) mutation in codon 12 or 13 medically necessary for predicting non-response to cetuximab in the treatment of metastatic colorectal cancer.

o Use of Erbitux is NOT recommended for the treatment of colorectal cancer with these mutations.

 

Head and Neck Cancer

• Used in combination with radiation therapy, cetuximab is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck.

• As a single agent, cetuximab is indicted for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

• Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with 5-FU.

 

Medicare will consider the use of Erbitux (cetuximab) as medically reasonable and necessary for the FDA approved uses as well as the following off-labeled indication:

 

Non-small cell lung cancer (NSCLC)

• First line therapy for reoccurrence or metastasis in combination with vinorebine and cisplatin in patients with performance status 0-2 (ECOG Performance Status).

 

 

CPT/HCPCS Codes

 

J9055 INJECTION, CETUXIMAB, 10 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

 

140.0 MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER

140.1 MALIGNANT NEOPLASM OF LOWER LIP VERMILION BORDER

140.3 MALIGNANT NEOPLASM OF UPPER LIP INNER ASPECT

140.4 MALIGNANT NEOPLASM OF LOWER LIP INNER ASPECT

140.5 MALIGNANT NEOPLASM OF LIP UNSPECIFIED INNER ASPECT

140.6 MALIGNANT NEOPLASM OF COMMISSURE OF LIP

140.8 MALIGNANT NEOPLASM OF OTHER SITES OF LIP

140.9 MALIGNANT NEOPLASM OF LIP UNSPECIFIED VERMILION BORDER

141.0 MALIGNANT NEOPLASM OF BASE OF TONGUE

141.1 MALIGNANT NEOPLASM OF DORSAL SURFACE OF TONGUE

141.2 MALIGNANT NEOPLASM OF TIP AND LATERAL BORDER OF TONGUE

141.3 MALIGNANT NEOPLASM OF VENTRAL SURFACE OF TONGUE

141.4 MALIGNANT NEOPLASM OF ANTERIOR TWO-THIRDS OF TONGUE PART UNSPECIFIED

141.5 MALIGNANT NEOPLASM OF JUNCTIONAL ZONE OF TONGUE

141.6 MALIGNANT NEOPLASM OF LINGUAL TONSIL

141.8 MALIGNANT NEOPLASM OF OTHER SITES OF TONGUE

141.9 MALIGNANT NEOPLASM OF TONGUE UNSPECIFIED

142.0 MALIGNANT NEOPLASM OF PAROTID GLAND

142.1 MALIGNANT NEOPLASM OF SUBMANDIBULAR GLAND

142.2 MALIGNANT NEOPLASM OF SUBLINGUAL GLAND

142.8 MALIGNANT NEOPLASM OF OTHER MAJOR SALIVARY GLANDS

142.9 MALIGNANT NEOPLASM OF SALIVARY GLAND UNSPECIFIED

143.0 MALIGNANT NEOPLASM OF UPPER GUM

143.1 MALIGNANT NEOPLASM OF LOWER GUM

143.8 MALIGNANT NEOPLASM OF OTHER SITES OF GUM

143.9 MALIGNANT NEOPLASM OF GUM UNSPECIFIED

144.0 MALIGNANT NEOPLASM OF ANTERIOR PORTION OF FLOOR OF MOUTH

144.1 MALIGNANT NEOPLASM OF LATERAL PORTION OF FLOOR OF MOUTH

144.8 MALIGNANT NEOPLASM OF OTHER SITES OF FLOOR OF MOUTH

144.9 MALIGNANT NEOPLASM OF FLOOR OF MOUTH PART UNSPECIFIED

145.0 MALIGNANT NEOPLASM OF CHEEK MUCOSA

145.1 MALIGNANT NEOPLASM OF VESTIBULE OF MOUTH

145.2 MALIGNANT NEOPLASM OF HARD PALATE

145.3 MALIGNANT NEOPLASM OF SOFT PALATE

145.4 MALIGNANT NEOPLASM OF UVULA

145.5 MALIGNANT NEOPLASM OF PALATE UNSPECIFIED

145.6 MALIGNANT NEOPLASM OF RETROMOLAR AREA

145.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PARTS OF MOUTH

145.9 MALIGNANT NEOPLASM OF MOUTH UNSPECIFIED

146.0 MALIGNANT NEOPLASM OF TONSIL

146.1 MALIGNANT NEOPLASM OF TONSILLAR FOSSA

146.2 MALIGNANT NEOPLASM OF TONSILLAR PILLARS (ANTERIOR) (POSTERIOR)

146.3 MALIGNANT NEOPLASM OF VALLECULA EPIGLOTTICA

146.4 MALIGNANT NEOPLASM OF ANTERIOR ASPECT OF EPIGLOTTIS

146.5 MALIGNANT NEOPLASM OF JUNCTIONAL REGION OF OROPHARYNX

146.6 MALIGNANT NEOPLASM OF LATERAL WALL OF OROPHARYNX

146.7 MALIGNANT NEOPLASM OF POSTERIOR WALL OF OROPHARYNX

146.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF OROPHARYNX

146.9 MALIGNANT NEOPLASM OF OROPHARYNX UNSPECIFIED SITE

147.0 MALIGNANT NEOPLASM OF SUPERIOR WALL OF NASOPHARYNX

147.1 MALIGNANT NEOPLASM OF POSTERIOR WALL OF NASOPHARYNX

147.2 MALIGNANT NEOPLASM OF LATERAL WALL OF NASOPHARYNX

147.3 MALIGNANT NEOPLASM OF ANTERIOR WALL OF NASOPHARYNX

147.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF NASOPHARYNX

147.9 MALIGNANT NEOPLASM OF NASOPHARYNX UNSPECIFIED SITE

148.0 MALIGNANT NEOPLASM OF POSTCRICOID REGION OF HYPOPHARYNX

148.1 MALIGNANT NEOPLASM OF PYRIFORM SINUS

148.2 MALIGNANT NEOPLASM OF ARYEPIGLOTTIC FOLD HYPOPHARYNGEAL ASPECT

148.3 MALIGNANT NEOPLASM OF POSTERIOR HYPOPHARYNGEAL WALL

148.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF HYPOPHARYNX

148.9 MALIGNANT NEOPLASM OF HYPOPHARYNX UNSPECIFIED SITE

149.0 MALIGNANT NEOPLASM OF PHARYNX UNSPECIFIED

149.1 MALIGNANT NEOPLASM OF WALDEYER'S RING

149.8 MALIGNANT NEOPLASM OF OTHER SITES WITHIN THE LIP AND ORAL CAVITY

149.9 MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY

153.0 MALIGNANT NEOPLASM OF HEPATIC FLEXURE

153.1 MALIGNANT NEOPLASM OF TRANSVERSE COLON

153.2 MALIGNANT NEOPLASM OF DESCENDING COLON

153.3 MALIGNANT NEOPLASM OF SIGMOID COLON

153.4 MALIGNANT NEOPLASM OF CECUM

153.5 MALIGNANT NEOPLASM OF APPENDIX VERMIFORMIS

153.6 MALIGNANT NEOPLASM OF ASCENDING COLON

153.7 MALIGNANT NEOPLASM OF SPLENIC FLEXURE

153.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARGE INTESTINE

153.9 MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

154.0 MALIGNANT NEOPLASM OF RECTOSIGMOID JUNCTION

154.1 MALIGNANT NEOPLASM OF RECTUM

154.2 MALIGNANT NEOPLASM OF ANAL CANAL

154.3 MALIGNANT NEOPLASM OF ANUS UNSPECIFIED SITE

154.8 MALIGNANT NEOPLASM OF OTHER SITES OF RECTUM RECTOSIGMOID JUNCTION AND ANUS

160.0 MALIGNANT NEOPLASM OF NASAL CAVITIES

160.1 MALIGNANT NEOPLASM OF AUDITORY TUBE MIDDLE EAR AND MASTOID AIR CELLS

160.2 MALIGNANT NEOPLASM OF MAXILLARY SINUS

160.3 MALIGNANT NEOPLASM OF ETHMOIDAL SINUS

160.4 MALIGNANT NEOPLASM OF FRONTAL SINUS

160.5 MALIGNANT NEOPLASM OF SPHENOIDAL SINUS

160.8 MALIGNANT NEOPLASM OF OTHER ACCESSORY SINUSES

160.9 MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

161.0 MALIGNANT NEOPLASM OF GLOTTIS

161.1 MALIGNANT NEOPLASM OF SUPRAGLOTTIS

161.2 MALIGNANT NEOPLASM OF SUBGLOTTIS

161.3 MALIGNANT NEOPLASM OF LARYNGEAL CARTILAGES

161.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF LARYNX

161.9 MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

162.0 MALIGNANT NEOPLASM OF TRACHEA

162.2 MALIGNANT NEOPLASM OF MAIN BRONCHUS

162.3 MALIGNANT NEOPLASM OF UPPER LOBE BRONCHUS OR LUNG

162.4 MALIGNANT NEOPLASM OF MIDDLE LOBE BRONCHUS OR LUNG

162.5 MALIGNANT NEOPLASM OF LOWER LOBE BRONCHUS OR LUNG

162.8 MALIGNANT NEOPLASM OF OTHER PARTS OF BRONCHUS OR LUNG

162.9 MALIGNANT NEOPLASM OF BRONCHUS AND LUNG UNSPECIFIED

173.12 SQUAMOUS CELL CARCINOMA OF EYELID, INCLUDING CANTHUS

173.22 SQUAMOUS CELL CARCINOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

173.32 SQUAMOUS CELL CARCINOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

173.42 SQUAMOUS CELL CARCINOMA OF SCALP AND SKIN OF NECK

195.0 MALIGNANT NEOPLASM OF HEAD FACE AND NECK

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician/nonphysician practitioner must substantiate the medical necessity for the use of this drug by clearly indicating the condition for which this drug is being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

o This documentation is usually found in the history and physical or in the office/progress notes.

• If the provider of the service is other than the ordering/referring physician/nonphysician practitioner, that provider must maintain copies of the ordering/referring physician/nonphysician practitioner’s order for the chemotherapy drug.

o The provider must state the clinical indication/medical necessity for using the chemotherapy drug in the order.

• Documentation in the medical record must support cetuximab was given for an indication specified in this LCD.

• When a portion of the drug is discarded, the medical record must clearly show the amount administered and the amount wasted.

• Documentation must be made available to Medicare upon request.

 

Treatment Logic:

• Cetuximab (Erbitux®) is a recombinant, human/mouse chimeric monoclonal antibody that binds specifically to the extracellular domain of the human epidermal growth factor receptor (EGFR).

• Cetuximab is composed of the Fv regions of a murine and-EGFR antibody with human IgG1 heavy and kappa light chain constant regions and has an approximate molecular weight of 152 kDa.

• Cetuximab is produced in mammalian (murine myeloma) cell culture.

 

Sources of Information and Basis for Decision

 

Azzoli, G., Baker, S., Temin, S., Pao, W., T., Brahmer, J., et al. (2009) American society of clinical practice guideline update on chemotherapy for stage IV non-small cell lung cancer, Journal of Clinical Oncology, 27 (36) 6251-6266.]

 

Chung, K., Shia, J., Kemeny, N., Shah, M., Schwartz, G., Tse, A., et al. (2005). Cetuximab shows activity in colorectal cancer patients with tumors that do not express the Epidermal Growth Factor Receptor by immunohistochemistry. Journal of Clinical Oncology, 23 (9) 1-8.

 

Clinical Pharmacology (www.clinical pharmacology.com) Revision date 12/08/2009

 

Compendia-Based Drug Bulletin. (October 2007). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/

 

Cunningham, D., Humblet, Y., Siena, S., Khayat, D., Bleiberg, H., Santoro, A., et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. The New England Journal of Medicine, 351, 337-345.

 

Dei Tos, A., Ellis, I. (2005). Assessing epidermal growth factor receptor expression in tumours: What is the value of current test methods? European Journal of Cancer, 41, 1383-1392.

 

FCSO LCD   29097, Cetuximab (Erbitux®), 09/12/2012. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

LCDs or policies from other Medicare contractors and Private Insurers

 

Lenz, H. (2004). Activity of cetuximab in patients with colorectal cancer refractory to both irinotecan and oxaliplatin. American Society of Clinical Oncology (ASCO), 2004 Annual Meeting.

 

Lynch, T., Patel, T., Dreisbach, L., McCleod, M., Heim, W., Hermann, R., et al. (2010) Cetuximab and first line taxane/carboplatin chemotherapy in advanced Non-Small-Cell Lung Cancer: Results of the randomized multicenter phase III Trail BMS099, Journal of Clinical Oncology, 28 (6) 911-916

 

Meropol, N. (2005). Epidermal Growth Factor Receptor inhibitors in colorectal cancer: It’s time to get back on target. Journal of Clinical Oncology, 23 (9), 1791-1793.

 

National Comprehensive Cancer Network (2007). Colon Cancer. Clinical Practice Guidelines in Oncology – V.1.2007.

 

NCCN Guidelines in Non-small Cell Cancer 2010 (v.2010.www.ncn.org)

 

NCCN Drug Compendium (www.nccn.org)October 2011

 

NCCN Drug Compendium (www.nccn.org) August 2012

 

Saltz, L. (2005). Epidermal Growth Factor Receptor-negative colorectal cancer: Is there truly such an entity? Clinical Colorectal Cancer. 5 (2) S98-S100.

 

Scartozzi, M., Bearzi, I., Berardi, R., Mandolesi, A., Fabris, G., and Cascinu, S. (2005). Epidermal Growth Factor Receptor (EGFR) status in primary colorectal tumors does not correlate with EGFR expression in related metastatic sites: Implications for treatment with EGFR-targeted monoclonal antibodies. Journal of Clinical Oncology, 22 (23) 4772-4778.

 

Thomson Micormedex (2007). The United States Pharmacopeia Drug Information (USP DI) for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, November 2011.

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, August 20, 2012.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

© Automated Clinical Guidelines, LLC 2012-2013

 

CMS LCD CETUXIMAB (ERBITUX®)