Herceptin (Trastuzumab) is a recombinant DNA-derived humanized monoclonal antibody indicated only for the treatment of patients whose breast tumors have HER-2 protein overexpression. Herceptin works by halting the out-of-control growth prompted by an overabundance of the HER-2/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:

• Patients with metastatic breast cancer whose tumors overexpress the HER-2 protein and who have received one or more chemotherapy regimens for their metastatic disease; and
  
  
• Herceptin in combination with paclitaxel for patients with metastatic breast cancer whose tumors overexpress the HER-2 protein and who have not received chemotherapy for their metastatic disease.

These are the only FDA approved indications. 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.

PRN References

02/1999, Herceptin

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