00006-5033-XX Ontruzant 150 MG (SAMSUNG BIOEPIS)
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.
Trastuzumab-dttb 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-dttb for the treatment of other conditions/diseases is considered investigational.
See also: Trastuzumab, Trastuzumab-pkrb, Trastuzumab-qyyp
Trastuzumab-dttb 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:
Invasive breast cancer that is HER2-over-expressing* if used as ANY ONE of the following:
Adjuvant therapy if ANY ONE of the following:
In combination with a taxane-based regimen (e.g., docetaxel, paclitaxel, etc.)
As a single agent following anthracycline-based therapy
Neoadjuvant therapy for breast preservation in combination with a taxane-based regimen (e.g., docetaxel, paclitaxel, etc.)
Treatment of recurrentor metastatic disease as ANY ONE of the following:
Single agent in individuals who have received one or more prior treatments for metastatic disease
First-line therapy in combination with paclitaxel
In combination with endocrine therapy with hormone receptor-positive or asymptomatic visceral disease if individual is ANY ONE of the following:
Pre-menopausal treated with ovarian ablation/suppression if prior endocrine therapy within 1 year OR no prior endocrine therapy within 1 year
Male receiving concomitant suppression of testicular steroidogenesis
Disease is hormone receptor-negative OR hormone receptor-positive refractory to endocrine therapy OR symptomatic visceral disease OR visceral crisis and used in combination with ANY ONE of the following:
Pertuzumab and a taxane as first-line therapy
Pertuzumab as second-line therapy in patients who were previously treated with trastuzumab without pertuzumab
Central nervous system cancer if ALL of the following:
Individual has leptomeningeal metastases from HER2-positive breast cancer
Treatment will be administered intrathecally
Gastric, esophageal or esophagogastric junction cancers that is HER2-overexpressing* if ALL of the following:
Disease is metastatic or locally advanced adenocarcinoma
Used in combination therapy with cisplatin and fluorouracil (5FU) or capecitabine for first-line therapy
Uterine cancer if ALL of the following:
Used in combination with carboplatin and paclitaxel
Used for advanced or recurrent uterine serous carcinoma
*HER2-positive overexpression criteria confirmed by ANY ONE of the following NCCN-defined methods:
Trastuzumab-dttb 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
Use for neoadjuvant and adjuvant breast cancer treatment is limited to a total of 52 weeks of therapy
DOSAGE & ADMINISTRATION
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.
Loading dose: 8 mg/kg x 1 for every 21 days dosing schedule
Maintenance dose: 6 mg/kg every 21 days
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed;
Use in the neo-adjuvant and adjuvant setting is limited to a total of 52 weeks of treatment
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).
Lexi-Comp Online. (2019, February). AHFS Dl. Trastuzumab. Retrieved March 28, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, March). Trastuzumab. Retrieved March 28, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Clinical Practice Guidelines Version 3.2018®. Invasive breast cancer. Retrieved March 28. 2019 from the National Comprehensive Cancer Network.
U.S. Food and Drug Administration. (2019, January). Center for Drug Evaluation and Research. Ontruzant® (trastuzumab-dttb) for injection, for intravenous use. Retrieved February 4, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761100s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 5/31/2019
MOST RECENT REVIEW DATE: 7/31/2019
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit (bu) = 10 mg