63459-0305-XX Herzuma 420 mg/vial (Teva Pharmaceuticals USA)
Trastuzumab-pkrb is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-pkrb is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture.
Trastuzumab-pkrb is biosimilar to trastuzumab and is likewise a mediator of antibody-dependent cellular toxicity (ADCC). As with trastuzumab, its product-mediated ADCC is preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Trastuzumab-pkrb for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Central Nervous system cancers
Esophagogastric junction adenocarcinoma
Trastuzumab-pkrb for the treatment of other conditions/diseases is considered investigational.
Trastuzumab-pkrb is considered medically appropriate if ALL of the following:
Baseline left ventricular ejection fraction (LVEF) is within normal limits
Individual is 18 years of age or older
Cancer is human epidermal growth factor receptor 2 (HER2)-positive
Diagnosis of ANY ONE of the following:
Breast cancer, invasive, if ANY ONE of the following:
Preoperative systemic therapy for breast conservation
Adjuvant systemic therapy
Recurrent or metastatic disease
Central nervous system cancer if ALL of the following:
Individual has leptomeningeal metastases from HER2-positive breast cancer
Treatment will be administered intrathecally
Endometrial carcinoma if ALL of the following:
Disease is advanced or recurrent uterine serous carcinoma
Used in combination with carboplatin and paclitaxel
Gastric, esophageal or esophagogastric junction cancers if ALL of the following:
Disease is metastatic or locally advanced
Used in combination therapy with cisplatin and fluorouracil (5FU) for first-line therapy
Human Epidermal Growth Factor Receptor 2 Protein, HER2 Overexpression Criteria by ANY ONE of the following:
Immunohistochemistry (IHC) assay 3+
Fluorescence in situ hybridization (FISH) assay ≥2.0 (HER2/CEP17 ratio)
Average HER2 copy number ≥ 6 signals/cell
Trastuzumab-pkrb is considered medically appropriate if for renewal if All of the following:
Individual continues to meet ALL of the initial criteria
Tumor shows response with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, e.g., cardiotoxicity, such as left ventricular dysfunction or cardiomyopathy; pulmonary toxicity (e.g., pneumonitis); neutropenia; neurotoxicity; infusion-related and hypersensitivity reactions
Left ventricular ejection fraction (LVEF) has not had an absolute decrease of more than 15% from baseline and is within normal limits
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Breast cancer, Endometrial, 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
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.
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.
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).
BlueCross BlueShield Association. Medical Policy Reference Manual. (7:2017). Trastuzumab (5.01.12). Retrieved December 31, 2018 from BlueWeb.
Lexi-Comp Online. (2018). AHFS Dl. Trastuzumab. Retrieved December 31, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, December). Trastuzumab. Retrieved December 31, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Trastuzumab. Retrieved December 31, 2018 from the National Comprehensive Cancer Network.
U.S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. Herzuma® (trastuzumab-pkrb) for injection. Retrieved December 31, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761091s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 4/30/2019
MOST RECENT REVIEW DATE: 4/30/2019
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 (bu) = 10 mg