L29097-LCD

Automated World Health

Local Coverage Determination (LCD) for Cetuximab (Erbitux®) (L29097)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29097

LCD Title

Cetuximab (Erbitux®)

Contractor's Determination Number J9055

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 07/06/2012 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See § 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 50

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1, Section 110.17

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Sections 10; 20; & 40 CMS Manual System, Pub. 100-08, Medicare Program Integrity, Chapter 13, Section 13.1.3

Social Security Act Section 1861(t)(2)(B)

Indications and Limitations of Coverage and/or Medical Necessity

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.

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. 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 reoccurance or metastasis in combination with vinorebine and cisplatin in patients with performance status 0-2 (ECOG Performance Status)

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

J9055 INJECTION, CETUXIMAB, 10 MG

ICD-9 Codes that Support Medical Necessity

140.0 - 149.9 opens in new window

153.0 - 153.9 opens in new window

154.0 - 154.8 opens in new window

160.0 - 160.9 opens in new window

161.0 - 161.9 opens in new window

162.0 - 162.9 opens in new window

MALIGNANT NEOPLASM OF UPPER LIP VERMILION BORDER - MALIGNANT NEOPLASM OF ILL-DEFINED SITES WITHIN THE LIP AND ORAL CAVITY

MALIGNANT NEOPLASM OF HEPATIC FLEXURE - MALIGNANT NEOPLASM OF COLON UNSPECIFIED SITE

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

MALIGNANT NEOPLASM OF NASAL CAVITIES - MALIGNANT NEOPLASM OF ACCESSORY SINUS UNSPECIFIED

MALIGNANT NEOPLASM OF GLOTTIS - MALIGNANT NEOPLASM OF LARYNX UNSPECIFIED

MALIGNANT NEOPLASM OF TRACHEA - 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

Diagnoses that Support Medical Necessity

See ICD-9 Codes that Support Medical Necessity

ICD-9 Codes that DO NOT Support Medical Necessity

All other diagnosis codes not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD.

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

All other diagnoses not listed as covered in the “ICD-9 Codes that Support Medical Necessity” section of this LCD. Back to Top

General Information

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

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they

may be subject to review for medical necessity.

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.

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. Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this

LCD was developed in cooperation with advisory groups, which include representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 03/01/2011

Revision History Number 4

Revision History Explanation Revision Number:4 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2012 Revised Effective Date:07/06/2012

LCR B2012-068

September 2012 Connection

Explanation of revision: Under the ‘Indications and Limitations Coverage and /or Medical Necessity’ section of the LCD, the new FDA label indications for Colorectal Cancer were added. In addition, the ‘Sources of Information and Basis for Decision’ section of the LCD was also updated. The effective date of this revision is for claims processed on or after 09/11/2012 for dates of service on or after 07/06/2012.

Revision Number:3

Start Date of Comment Period:N/A Start Date of Notice Period:02/01/2012 Revised Effective Date: 11/07/2011

LCR B2012-029

January 2012 Connection

Explanation of revision: Under the ‘Indications and Limitations Coverage and /or Medical Necessity’ section of the LCD the new FDA label indication for recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck was added. Under ‘ICD-9 Codes that Support Medical Necessity’ diagnosis codes 173.12, 173.22, 173.32, 173.42, were added. The ‘Sources of Information’ section of the LCD was also updated. The effective date of this revision is for dates of service on or after 11/07/2011 for claims processed on or after 01/26/2012.

Revision Number:2

Start Date of Comment Period:N/A

Start Date of Notice Period: 03/01/2011 Revised Effective Date: 02/21/2011

LCR B2011-038

February 2011 Update

Explanation of revision: “Under Indications and Limitations Coverage and /or Medical Necessity” section of the LCD, added new off label indication for Non-Small Cell Lung Cancer (NSCLC). In addition, the “Sources of Information and Basis for Decision” and “CMS National Coverage Policy” sections were updated. The effective date of this revision is based on the date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:12/01/2009 Revised Effective Date:07/22/2009

LCR B2009-107

November 2009 Update

Explanation of revision: Under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD, new FDA verbiage was added concerning colorectal cancer coverage. In addition, the “Sources of Information and Basis for Decision” section was updated. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29097) replaces LCD L25303 as the policy in notice. This document (L29097) is effective on 02/02/2009.

Reason for Change Typographical Correction