BlueCross BlueShield of Tennessee Medical Policy Manual

Pertuzumab

NDC CODE(S)

50242-0145-XX Perjeta 420 MG/14ML SOLN (GENENTECH)

DESCRIPTION

Pertuzumab is a recombinant monoclonal antibody.  It is an antineoplastic agent that targets the human epidermal growth factor receptor 2 protein known as HER2.  It blocks two major intracellular signaling pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K).  This results in cell growth arrest and apoptosis (cell destruction), inhibiting the proliferation of human tumor cells.  By combining pertuzumab with trastuzumab, tumor inhibition was significantly increased.  

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Breast Cancer

840mg x 1 dose, then 420mg every 21 days thereafter, until disease progression or unmanageable toxicity

For neo-adjuvant/adjuvant treatment, continued use for greater than 18 cycles ( every 3 weeks for 1 year) is not recommended

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed for metastatic or recurrent disease;

Coverage for neo-adjuvant/adjuvant use will be provided for twelve months and may NOT 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, February). AHFS DI. Pertuzumab. Retrieved February 25, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, March). Pertuzumab. Retrieved February 25, 2019 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Pertuzumab. Retrieved February 25, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. Perjeta® (pertuzumab) injection, for intravenous use. Retrieved February 25, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125409s123lbl.pdf. 

ORIGINAL EFFECTIVE DATE: 7/5/2012

MOST RECENT REVIEW DATE:  4/9/2019

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 = 1 mg

DIAGNOSIS

MAXIMUM UNITS

Breast Cancer

Loading Dose – 840 billable units x 1 dose

Maintenance Dose – 420 billable units every 21 days