L29297

 

TRASTUZUMAB (HERCEPTIN®)

 

11/11/2010

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Trastuzumab (Herceptin®)-J9355

• There are two methods of testing for HER2 tumor status in women with breast cancer:

o Immunohistochemistry (IHC).

o Fluorescence in situ hybridization (FISH).

• HER2 test results are interpreted as follows:

o HER2 positive status is IHC 3+ or FISH positive.

o 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:

o Counting additional cells in the tissue sample.

o Retesting with FISH.

o 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.

o The pathology laboratory where the HER2 testing is done should be accredited to perform such testing.

o 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

o 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

o 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

o 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:

o 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:

 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).

 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.

 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.

 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.

o 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.

 

CPT/HCPCS Codes

 

J9355 INJECTION, TRASTUZUMAB, 10 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

150.0 MALIGNANT NEOPLASM OF CERVICAL ESOPHAGUS

150.1 MALIGNANT NEOPLASM OF THORACIC ESOPHAGUS

150.2 MALIGNANT NEOPLASM OF ABDOMINAL ESOPHAGUS

150.3 MALIGNANT NEOPLASM OF UPPER THIRD OF ESOPHAGUS

150.4 MALIGNANT NEOPLASM OF MIDDLE THIRD OF ESOPHAGUS

150.5 MALIGNANT NEOPLASM OF LOWER THIRD OF ESOPHAGUS

150.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED PART OF ESOPHAGUS

150.9 MALIGNANT NEOPLASM OF ESOPHAGUS UNSPECIFIED SITE

151.0 MALIGNANT NEOPLASM OF CARDIA

174.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF FEMALE BREAST

174.1 MALIGNANT NEOPLASM OF CENTRAL PORTION OF FEMALE BREAST

174.2 MALIGNANT NEOPLASM OF UPPER-INNER QUADRANT OF FEMALE BREAST

174.3 MALIGNANT NEOPLASM OF LOWER-INNER QUADRANT OF FEMALE BREAST

174.4 MALIGNANT NEOPLASM OF UPPER-OUTER QUADRANT OF FEMALE BREAST

174.5 MALIGNANT NEOPLASM OF LOWER-OUTER QUADRANT OF FEMALE BREAST

174.6 MALIGNANT NEOPLASM OF AXILLARY TAIL OF FEMALE BREAST

174.8 MALIGNANT NEOPLASM OF OTHER SPECIFIED SITES OF FEMALE BREAST

174.9 MALIGNANT NEOPLASM OF BREAST (FEMALE) UNSPECIFIED SITE

175.0 MALIGNANT NEOPLASM OF NIPPLE AND AREOLA OF MALE BREAST

175.9 MALIGNANT NEOPLASM OF OTHER AND UNSPECIFIED SITES OF MALE BREAST

196.0 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF HEAD FACE AND NECK

196.1 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRATHORACIC LYMPH NODES

196.2 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRA-ABDOMINAL LYMPH NODES

196.3 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF AXILLA AND UPPER LIMB

196.5 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF INGUINAL REGION AND LOWER LIMB

196.6 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF INTRAPELVIC LYMPH NODES

196.8 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES OF MULTIPLE SITES

196.9 SECONDARY AND UNSPECIFIED MALIGNANT NEOPLASM OF LYMPH NODES SITE UNSPECIFIED

197.0 SECONDARY MALIGNANT NEOPLASM OF LUNG

197.1 SECONDARY MALIGNANT NEOPLASM OF MEDIASTINUM

197.2 SECONDARY MALIGNANT NEOPLASM OF PLEURA

197.3 SECONDARY MALIGNANT NEOPLASM OF OTHER RESPIRATORY ORGANS

197.4 SECONDARY MALIGNANT NEOPLASM OF SMALL INTESTINE INCLUDING DUODENUM

197.5 SECONDARY MALIGNANT NEOPLASM OF LARGE INTESTINE AND RECTUM

197.6 SECONDARY MALIGNANT NEOPLASM OF RETROPERITONEUM AND PERITONEUM

197.7 MALIGNANT NEOPLASM OF LIVER SECONDARY

197.8 SECONDARY MALIGNANT NEOPLASM OF OTHER DIGESTIVE ORGANS AND SPLEEN

198.0 SECONDARY MALIGNANT NEOPLASM OF KIDNEY

198.1 SECONDARY MALIGNANT NEOPLASM OF OTHER URINARY ORGANS

198.2 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

 

 

Documentation 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.

Utilization Guidelines

• Dosage and Administration:

o Do not administer trastuzumab (Herceptin®) as an intravenous push or bolus.

o Do not mix Herceptin with other drugs.

o Trastuzumab is supplied as a lyophilized, sterile powder nominally containing 440 mg trastuzumab per vial.

o See the FDA product label for specific recommended dosages of trastuzumab (Herceptin®) for adjuvant and metastatic breast cancer treatments.

 

Treatment Logic

• Trastuzumab is a monoclonal antibody, one of a group of drugs designed to attack specific cancer cells.

• Trastuzumab 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 treatment of HER2-negative breast cancers.

 

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/.

 

FCSO LCD29297, Trastuzumab (Herceptin®), 11/11/2010. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

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.

 

 

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CMS LCD TRASTUZUMAB (HERCEPTIN®)