L29178

 

FULVESTRANT (FASLODEX®)

 

01/25/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Fulvestrant (Faslodex®)-J9395.

 

Medicare will consider Fulvestrant (Faslodex ®) medically reasonable and necessary for the Food and Drug Administration (FDA) approved uses, as well as for the treatment of the following off-labeled indication:

• For the treatment of male breast cancer.

 

CPT/HCPCS Codes

 

 

J9395 INJECTION, FULVESTRANT, 25 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

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

 

 

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.

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, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

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

• For patients receiving Fulvestrant, the record must clearly indicate the medical need for the use of this drug.

o The record must validate that the patient is postmenopausal, has hormone receptor positive metastatic breast cancer and has disease progression following antiestrogen therapy.

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

 

Utilization Guidelines

 

• Dosage and Administration:

o Faslodex 500mg should be administered:

 Intramuscularly (IM) into the buttocks slowly.

 As two 5ml injections.

 One in each buttock.

 On days 1, 15, 29.

 Once monthly thereafter.

 

Treatment Logic

 

• Fulvestrant (Faslodex®) is an estrogen receptor antagonist that binds to the estrogen receptor in a competitive manner with affinity comparable to that of estradiol.

• Many breast cancers have estrogen receptors (ER) and the growth of these tumors can be stimulated by estrogen. Fulvestrant down regulates the ER protein in human breast cancer cells.

• Fulvestrant (Faslodex®) is indicated for the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

 

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 LCD 29178, Fulvestrant (Faslodex®), 01/25/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Fulvestrant (Faslodex®) package insert (2010) AstraZeneca Pharmaceuticals LP, Wilmington, DE

 

Fulvestrant (Faslodex®) package insert (2002) AstraZeneca Pharmaceuticals LP, Wilmington, DE. This document was utilized to determine the indications and limitations of coverage.

 

National Comprehensive Cancer Network (2007). Breast Cancer. Clinical Practice Guidelines in Oncology – V. 2.2007.

 

Thomson Micromedex (2006). 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, CDER web site updates, April 2007.

 

 

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.

 

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CMS LCD FULVESTRANT (FASLODEX®)