50242-0145-XX Perjeta 420 MG/14ML SOLN (GENENTECH)
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.
Pertuzumab for the treatment of Breast Cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pertuzumab for the treatment of other conditions/diseases is considered investigational.
Pertuzumab is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Baseline Left Ventricular Ejection Fraction (LVEF) within normal limits
Human epidermal growth factor receptor 2-positive (HER2-positive) disease per ANY ONE of the following over expression criteria:
Immunohistochemistry (IHC) assay 3+
Fluorescence in situ hybridization (FISH) assay ≥2.0 (HER2/CEP17 ratio)
AverageHER2 copy number ≥ 6 signals/cell
Diagnosis of breast cancer with treatment of ANY ONE of the following:
Used as adjuvant treatment if ALL of the following:
Disease is early stage or locally advanced at high risk of recurrence
Used in combination with a trastuzumab-based regimen
Used as neoadjuvant treatment for breast preservation if ALL of the following:
Disease is locally advanced, inflammatory or early stage
Used in combination with a trastuzumab-based regimen
Used for recurrent or metastatic disease if ANY ONE of the following:
Used as first-line therapy in combination with trastuzumab and paclitaxel or docetaxel
Used as second-line therapy in combination with trastuzumab, having previously received trastuzumab but not previously received pertuzumab
Pertuzumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, e.g., cardiotoxicity (i.e. left ventricular dysfunction, cardiomyopathy); neutropenia; neurotoxicity; infusion-related and hypersensitivity reactions, including anaphylaxis.
Left ventricular ejection fraction (LVEF) is >45% OR LVEF is ≥40% and absolute decrease is <10% from baseline (results must be less than 3 months old)
Use for Breast Cancer Adjuvant or Neo-adjuvant treatment is limited to one year of treatment (18 cycles total) and therapy cannot be renewed
DOSAGE & ADMINISTRATION
840mg x 1 dose, then 420mg every 21 days thereafter, until disease progression or unmanageable toxicityFor 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
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.
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.
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).
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
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 1 mg