BlueCross BlueShield of Tennessee Medical Policy Manual

Trastuzumab

NDC CODE(S)

50242-0132-XX Herceptin 150 MG SOLR (GENENTECH)

DESCRIPTION

Trastuzumab is a recombinant DNA-derived IgG1 kappa monoclonal antibody that selectively binds to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2.  Trastuzumab has been shown to inhibit the proliferation of human tumor cells that overexpress HER2.  Trastuzumab is also a mediator of antibody-dependent cellular cytotoxicity (ADCC).  Trastuzumab-mediated ADCC, a method of cancer cell destruction, is preferentially exerted on those cancer cells which overexpress HER2.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*HER2-positive overexpression criteria confirmed by ANY ONE of the following NCCN-defined methods:

  • Immunohistochemistry (IHC) assay 3+

  • In situ hybridization (ISH) assay average HER2 copy number ≥ 6.0 signals/cell

  • Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio ≥ 2.0

 

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Breast cancer

Gastric, Esophageal and Esophagogastric Junction Cancers

Loading dose: 8mg/kg x 1 for every 21 days dosing schedule

Maintenance dose: 6mg/kg every 21 days

OR

Loading dose: 4mg/kg x 1 for weekly (7 days) dosing schedule

Maintenance dose: 2mg/kg every 7 days

Leptomeningeal Metastases from Breast Cancer

Escalating doses up to 100 mg intrathecally weekly.

 - Dosing is highly variable and should be individualized.

Uterine Cancer

Loading dose: 8 mg/kg x 1 for every 21 days dosing schedule

Maintenance dose: 6 mg/kg every 21 days

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Lexi-Comp Online. (2019). AHFS Dl. Trastuzumab. Retrieved February 4, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, January). Trastuzumab. Retrieved February 4, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Clinical Practice Guidelines Version 3.2018®. Invasive breast cancer. Retrieved February 4, 2019 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Trastuzumab. Retrieved February 4, 2019 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration. (2018, November). Center for Drug Evaluation and Research. Herceptin® (trastuzumab). Retrieved February 4, 2019from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf.

ORIGINAL EFFECTIVE DATE: 12/1/2016

MOST RECENT REVIEW DATE:  5/31/2019

ID_MRx

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit (bu) = 10 mg

INDICATION

SCHEDULE

LOADING DOSE

MAINTENANCE

Breast cancer and Gastric/Esophageal/Gastro-esophageal junction Cancers

7 day dosing schedule

45 bu

30 bu

21 day dosing schedule

90 bu

75 bu

Uterine Cancer

21 day dosing schedule

90 bu

75 bu

CNS Cancer

7 day dosing schedule

N/A

15 bu