L29297-LCD

Automated World Health

Local Coverage Determination (LCD) for Trastuzumab (Herceptin®) (L29297)

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 L29297

LCD Title

Trastuzumab (Herceptin®)

Contractor's Determination Number J9355

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 11/11/2010 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, Chapter 15, Section 50

CMS Manual System, Pub. 100-04, Medicare Claims Processing Manual, Chapter 17, Section 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 Trastuzumab (Herceptin®)-J9355

Trastuzumab is a monoclonal antibody, one of a group of drugs designed to attack specific cancer cells. Trastuzumab’s targets are cancer cells that overexpress an oncogene called HER2 or HER2/neu, which occurs in high numbers in about 25 to 30 percent of breast cancers. According to the National Comprehensive Cancer Network (NCCN), breast cancers can be categorized as being HER2 positive or HER2 negative. HER2-positive breast cancer is faster growing and considered more aggressive. Studies indicate that the drug trastuzumab (Herceptin) is effective in treatment of HER2-positive early stage breast cancer and HER2-positive metastatic breast cancer. Trastuzumab is not effective in the treatmentof HER2-negative breast cancers.

There are two methods of testing for HER2 tumor status in women with breast cancer: immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). HER2 test results are interpreted as follows:

• HER2 positive status is IHC 3+ or FISH positive

• HER2 negative status is IHC 0, 1+ or FISH negative

• A borderline IHC result of 2+ should be followed by performing a FISH test.

• A borderline FISH result of an average HER2 gene/chromosome 17 ratio of 1.8 to 2.2 (or an average of greater than 4 to less than 6 HER2 gene copies/cell) should be followed by one of the following:

• Counting additional cells in the tissue sample

• Retesting with FISH

• Performing an IHC test

Results from both tests are used in the clinical setting, and the results of the tests influence treatment choices for women with breast cancer. The pathology laboratory where the HER2 testing is done should be accredited to perform such testing. It should have quality control procedures in place to ensure that the test is done correctly, and a quality assurance plan to validate (i.e., determine the accuracy of) the HER2 test results.

Trastuzumab (Herceptin®) is FDA approved for the following indications:

Adjuvant Breast Cancer

Herceptin is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer:

• As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel

• With docetaxel and carboplatin

• As a single agent following multi-modality anthracycline based therapy

Metastatic Breast Cancer Herceptin is indicated:

• In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer

• As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastic disease

Metastatic Gastric Cancer

Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Medicare will consider trastuzumab medically necessary when provided for its FDA approved uses, as well as for the treatment of any of the following off-labeled indications:

For metastatic and non-metastatic breast cancer, trastuzumab may be considered medically reasonable and necessary when incorporated into the adjuvant therapy in the following recommended uses by the NCCN Drugs and Biologics Compendium:

1. Preoperative chemotherapy in combination with paclitaxel followed by FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen with trastuzumab for patients with human epidermal growth factor receptor 2

(HER2)-positive stage IIA, IIB, or T3, N1, M0 disease who desire breast preservation and fulfill criteria for breast- conserving surgery except for tumor size or for patients with locally advanced disease (stage IIIA, IIIB, or IIIC)

2. Adjuvant chemotherapy for human epidermal growth factor receptor 2 (HER2)-positive, stage I, IIA, IIB, or T3,

N1, M0 disease (ductal, lobular, mixed, or metaplastic histologies) that is node-positive, node-negative with tumor 0.5 cm or greater in hormone receptor-negative patients, or node-negative with tumor 0.6 to 1 cm, grade 2 or 3, or with unfavorable features or tumor greater than 1 cm in hormone receptor-positive patients, or for patients with locally advanced disease (stages IIIA, IIIB, or IIIC)

• concurrently with paclitaxel following AC (doxorubicin and cyclophosphamide) regimen as preferred regimen

• in TCH (docetaxel, carboplatin, and trastuzumab) regimen as preferred regimen

• in combination with docetaxel followed by FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen

• following chemotherapy

• in combination with docetaxel following AC regimen

3. Used in combination with aromatase inhibition for the treatment of recurrent or stage IV estrogen receptor- positive, human epidermal growth factor receptor 2 (HER2)-positive disease in postmenopausal women* who have received no prior endocrine therapy within one year

*Men with breast cancer should be treated similarly to postmenopausal women, except that use of an aromatase inhibitor is ineffective without concomitant suppression of testicular steroidogenesis

4. Preferred regimen for patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer that is hormone receptor-negative or hormone receptor-positive and endocrine refractory and not characterized by bone or soft tissue involvement only or asymptomatic visceral disease as:

• first-line chemotherapy in combination with docetaxel, vinorelbine, or capecitabine or with paclitaxel with or without carboplatin

• treatment for trastuzumab-exposed HER2-positive disease in combination with lapatinib without cytotoxic therapy, with docetaxel, vinorelbine, or capecitabine, or with paclitaxel with or without carboplatin

The timing of therapy combination with other agents or regimen, dosage, and duration of therapy should be based on NCCN guidelines and the package insert.

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

J9355 INJECTION, TRASTUZUMAB, 10 MG

ICD-9 Codes that Support Medical Necessity

150.0 - 150.9 opens in new window

MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS - MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

151.0 MALIGNANT NEOPLASM OF CARDIA

174.0 - 174.9 opens in new window 175.0 - 175.9 opens in new window

196.0 - 196.9 opens in new window

197.0 - 197.8 opens in new window

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST - MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST - MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF HEAD FACE AND NECK - SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES SITE UNSPECIFIED

SECONDARY MALIGNANT NEOPLASM OF LUNG - SECONDARY MALIGNANT NEOPLASM OF OTHER DIGESTIVE ORGANS AND SPLEEN

198.1 SECONDARY MALIGNANT NEOPLASM OF KIDNEY

198.2 SECONDARY MALIGNANT NEOPLASM OF OTHER URINARY ORGANS

198.3 SECONDARY MALIGNANT NEOPLASM OF SKIN

198.4 SECONDARY MALIGNANT NEOPLASM OF OTHER PARTS OF NERVOUS SYSTEM

198.5 SECONDARY MALIGNANT NEOPLASM OF BONE AND BONE MARROW

198.6 SECONDARY MALIGNANT NEOPLASM OF OVARY

198.7 SECONDARY MALIGNANT NEOPLASM OF ADRENAL GLAND

198.82 SECONDARY MALIGNANT NEOPLASM OF GENITAL ORGANS

198.89 SECONDARY MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES

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 must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are 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, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug. The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

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.

Dosage and Admininstration

Do not administer trastuzumab (Herceptin®) as an intravenous push or bolus. Do not mix Herceptin with other drugs. Trastuzumab is supplied as a lyophilized, sterile powder nominally containing 440 mg trastuzumab per vial. See the FDA product label for specific recommended dosages of trastuzumab (Herceptin®) for adjuvant and

metastatic breast cancer treatments.

Sources of Information and Basis for Decision

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

National Comprehensive Cancer Network (2007). Invasive Breast Cancer. Clinical Practice Guidelines in Oncology

– V.2.2007.

Thomson Micromedex (2007). USP DI Drug Information 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, Drugs@FDA, October 2010.

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 includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/01/2010

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:12/01/2010 Revised Effective Date 11/11/2010

LCR B2010-076

November 2010 Update

Explanation of revision: Under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD, new FDA indications were added for metastatic gastric or gastroesophageal junction adenocarcinoma. Under the “ICD-9 Codes that Support Medical Necessity” section, ICD-9-CM code range 150.0-150.9, and ICD-9- CM code 151.0 were added. In addition, the “CMS National Coverage Policy,” and “Sources of Information and Basis for Decision” sections were updated. The effective date of this LCD revision is for claims processed on or after 11/11/2010 for dates of service on or after 10/20/2010.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:12/01/2010 Revised Effective Date 10/26/2010

LCR B2010-073

November 2010 Update

Explanation of revision: Under the “Indications and Limitations of Coverage and/or Medical Necessity” section of the LCD, verbiage was updated/revised to include categories and testing for HER2 tumors, and to add current off- label indications for breast cancer as outlined in the NCCN compendium. 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 (L29297) replaces LCD L25079 as the policy in notice. This document (L29297) is effective on 02/02/2009.

Reason for Change