BlueCross BlueShield of Tennessee Medical Policy Manual

Trastuzumab

NDC CODE(S)

Herceptin 440 MG SOLR 50242-0056-xx (GENENTECH)

 

Herceptin 440 MG SOLR 50242-0134-xx (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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications

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

Maintenance dose: 2mg/kg every 7 days

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

Maintenance dose: 6mg/kg every 21 days

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 

Human Epidermal Growth Factor Receptor 2 Protein, HER2 Overexpression Criteria

Any one of the following:

Karnofsky Performance Status

KPS 100 Normal; no complaints, no evidence of disease
KPS 90 Able to carry on normal activity; minor signs or symptoms of disease
KPS 80 Normal activity with effort; some signs or symptoms of disease
KPS 70 Cares for self; unable to carry on normal activity or do active work
KPS 60  Requires occasional assistance but is able to care for most personal needs
KPS 50 Requires considerable assistance and frequent medical care
KPS 40 Disabled; requires special care and assistance
KPS 30  Severely disabled; hospitalization is indicated, although death not imminent
KPS 20 Very sick; hospitalization necessary, active support treatment necessary
KPS 10 Moribund; fatal processes progressing rapidly

KPS 0  

Dead

For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of trastuzumab for the treatment of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2015). Trastuzumab (5.01.12). Retrieved June 30, 2016 from BlueWeb.

Lexi-Comp Online. (2016, March). AHFS Dl. Trastuzumab. Retrieved June 30, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, June). Trastuzumab. Retrieved June 30, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Trastuzumab. Retrieved June 30, 2016 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration. (2016, March). Center for Drug Evaluation and Research. Herceptin® (trastuzumab). Retrieved June 30, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103792s5330lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Trastuzumab (Herceptin®)

  1. Is this the initial request for trastuzumab for this individual?

If yes, go to question #2

If no, go to question #8

  1. Is there documentation of a baseline left ventricular ejection fraction (LVEF) for this individual?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of invasive breast cancer that is human epidermal growth factor receptor 2 (HER2) -positive disease requesting treatment for ANY ONE of the following?

If yes, go to question #6

If no, go to question #4

  1. Does the individual have a diagnosis of central nervous system cancer further diagnosed as leptomeningeal metastases from breast cancer if intracerebrospinal fluid (CSF) treatment is for ANY ONE of the following?

If yes, go to question #6

If no, go to question #5

  1. Does the individual have a diagnosis of gastric cancer, esophageal cancer or esophagogastric junction adenocarcinoma with ALL of the following?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Are the requested billable units for the loading dose 92 and the maintenance dose 69 billable units or less every 21 days (1 billable unit = 10 mg) for an authorization of six months?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the dosage schedule and amount requested for the individual ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 3 – 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the tumor show response to treatment with absence of toxicity or disabling adverse reaction?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there documentation that the left ventricular ejection fraction (LVEF) has decreased no more than 15% from baseline and is within normal limits?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 69 billable units or less (1 billable unit = 10 mg) every 21 days with maintenance dosing of 2mg/kg every 7 days or 6mg/kg every 21 days for an authorization of 6 months or less?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.