Mountain State Medical Policy Bulletin
Section: Injections
Number: I-21
Topic: Trastuzumab (Herceptin®)
Effective Date: May 1, 2006
Issued Date: September 10, 2007
Date Last Reviewed: 03/2007

General Policy Guidelines

Indications and Limitations of Coverage

Trastuzumab (Herceptin®) is a recombinant DNA-derived humanized monoclonal antibody indicated only for the treatment of patients whose breast tumors have HER2 protein overexpression. Herceptin works by halting the out-of-control growth prompted by an overabundance of the HER2/neugene.

Coverage for herceptin is determined according to individual or group customer benefits. Herceptin is eligible for patients with breast cancer (174.0-174.9, 175.0-175.9) who meet the following criteria:

  • As a single agent in patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

  • In combination with other chemotherapeutic agents for patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease.

  • As an adjuvant in combination with other chemotherapeutic agents for patients with early-stage breast cancer who overexpress the HER2 protein.

Other indications are currently being studied in the clinical trial setting with no long-term outcomes available. All other indications are considered experimental/investigational, and therefore, not covered. A participating, preferred, or network provider can bill the member for the denied service.

Herceptin is administered by intravenous infusion at an initial loading dose of 4 mg/kg over 90 minutes. If prior infusions are well tolerated, subsequent weekly doses of 2 mg/kg herceptin may be administered over 30-60 minutes. Each vial provides approximately 3 weekly doses. A weekly dose may be administered for the duration of the patient's life. Herceptin may be administered in an outpatient setting.

Candidates for treatment with herceptin should undergo thorough baseline cardiac assessment including a history and physical exam and one or more of the following: EKG, echocardiogram, and MUGA scan. Extreme caution should be exercised in treating patients with preexisting cardiac dysfunction. Patients receiving herceptin should undergo frequent monitoring for deteriorating cardiac function. Discontinuation of herceptin therapy should be strongly considered in patients who develop clinically significant congestive heart failure.

NOTE:
See Medical Policy Bulletin G-16 for additional information on Chemotherapy for Malignant Disease.

NOTE:
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Procedure Codes

J9355     

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. The use of the FDA approved drug trastuzumab for conditions other than those listed as eligible on this policy is considered eligible when determined medically necessary based on the patient’s condition.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

Trastuzumab, USPDI-Vol. I, Edition 24, 2004 Microdex, Inc.

Trastuzumab After Adjuvant Chemotherapy in HER2-Positive Breast Cancer, The New England Journal of Medicine, Vol. 353, No. 16, 10/2005

Trastuzumab Plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer, The New England Journal of Medicine, Vol. 353, No. 16, 10/2005

Trastuzumab in the Treatment of Breast Cancer, The New England Journal of Medicine, Vol. 353, No. 16, 10/2005

Herceptin Combined with Chemotherapy Improves Disease Survival for Patients with Early-Stage Breast Cancer, National Cancer Institute (NCI), NCI News, 04/2005

Trastuzumab (Herceptin®) Effective in Early Breast Cancer, National Cancer Institute (NCI), NCI News, 10/2005

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Glossary




This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.