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.

REFER TO DECISION SUPPORT TREE

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 6 cycles is not recommended

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).

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

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2016). Pertuzumab for treatment of HER2-positive malignancies (5.01.20). Retrieved June 29, 2017 from BlueWeb.

Lexi-Comp Online. (2017, March). AHFS DI. Pertuzumab. Retrieved June 29, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, February). Pertuzumab. Retrieved June 29, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Pertuzumab. Retrieved November 16, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, March). Center for Drug Evaluation and Research. Perjeta® (pertuzumab). Retrieved June 29, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf.

ORIGINAL EFFECTIVE DATE:  7/5/2012

MOST RECENT REVIEW DATE:  9/12/2017

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

Pertuzumab (Perjeta ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Does the individual have a diagnosis of breast cancer and meet ALL of the following?

If yes, go to question #6

If no, go to question #3

  1. Does the individual have a diagnosis of early stage or locally advanced breast cancer for adjuvant treatment in combination with a trastuzumab-based regimen when pertuzumab was not used as part of the neoadjuvant therapy?

If yes, go to question #6

If no, go to question #4

  1. Does the individual have a diagnosis of breast cancer that is locally advanced, inflammatory or early stage for neoadjuvant treatment for breast preservation and treatment is in combination with a trastuzumab-based regimen?

If yes, go to question #6

If no, go to question #5

  1. Does the individual have a diagnosis of recurrent or metastatic disease if ANY ONE of the following?

If yes, go to question #6

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

  1. Is the request for 840 billable units x 1, then 420 billable units every 21 days for dosage of 840mg x 1 dose, then 420mg every 21 days thereafter in an authorization of 6 months with possible renewal until disease progression or unmanageable toxicity (for neo-adjuvant/adjuvant treatment, continued use for greater than 6 cycles is not recommended)?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

  1. Is the request for renewal for the treatment of adjuvant or neo-adjuvant therapy?

If yes, this does not meet medical necessity and/or medical appropriateness criteria

If no, go to question #8

  1. Does the individual continue to meet the initial approval criteria in questions 2, 5 & 6? 

If yes, go to question #9

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

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread with absence of unacceptable toxicity from the drug, e.g., cardiotoxicity (i.e. left ventricular dysfunction, cardiomyopathy); neutropenia; neurotoxicity; infusion-related and hypersensitivity reactions?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

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