50242-0077-XX Herceptin Hylecta 600 MG - 10,000 MG UNT/5ML SOLN (GENENTECH, INC)
Trastuzumab and hyaluronidase-oysk is a combination of trastuzumab and recombinant human hyaluronidase. Trastuzumab, a humanized IgG1 kappa monoclonal antibody, selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2.
Hyaluronidase is an endoglycosidase, a glycosylated single-chain protein produced by mammalian cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase has been shown to increase the absorption rate of the trastuzumab into the systemic circulation when administered subcutaneously.
Trastuzumab and hyaluronidase-oysk for the treatment of breast cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Trastuzumab and hyaluronidase-oysk for the treatment of other conditions/diseases is considered investigational.
Trastuzumab and hyaluronidase-oysk is considered medically appropriate if ALL of the following criteria are met:
Baseline left ventricular ejection fraction (LVEF) within normal limits
Individual is 18 years or older
Cancer is human epidermal growth factor receptor 2 (HER2)-overexpressing*
Will not be used in combination with trastuzumab or ado-trastuzumab emtansine
BCBST Requirement: Will not be used with intravenous chemotherapy agents or during intravenous chemotherapy sessions
Diagnosis of Breast Cancer used for ANY ONE of the following:
Adjuvant therapy in combination with a taxane-based regimen (e.g., docetaxel, paclitaxel, etc.) OR as a single agent following anthracycline-based therapy
Metastatic disease as ANY ONE of the following:
Single agent in Individual who have received one or more prior treatments for metastatic disease
First-line therapy in combination with paclitaxel
*HER2-positive overexpression criteria
(ANY ONE of the Following)
Immunohistochemistry (IHC) assay 3+
In situ hybridization (ISH) assay average HER2 copy number ≥ 6.0 signals/cell
Dual-probe in situ hybridization (ISH) assay HER2/CEP17 ratio ≥ 2.0
Trastuzumab and hyaluronidase-oysk is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, such as, cardiotoxicity (e.g., left ventricular dysfunction, cardiomyopathy, etc.), pulmonary toxicity (i.e., pneumonitis), neutropenia, infusion-related reactions, etc.;
LVEF has not had an absolute decrease of ≥ 16% from pre-treatment baseline and is within the institutional normal limits
LVEF has not had an absolute decrease of ≥ 10% from pre-treatment baseline and is below the institutional lower limits of normal
For the adjuvant treatment of breast cancer, the patient has not exceeded a maximum of 52 weeks of therapy
|INDICATION(S)||DOSAGE & ADMINISTRATION|
Administer 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) subcutaneously over approximately 2-5 minutes once every three weeks.Herceptin Hylecta should be administered by healthcare professional.
|Note: Do not substitute Herceptin Hylecta for or with ado-trastuzumab emtansine.|
LENGTH OF AUTHORIZATION
Coverage is provided for six months and may be renewed
Use in the 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).
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, March). Trastuzumab-Hyaluronidase-oysk. Retrieved April 4, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Trastuzumab and hyaluronidase-oysk. Retrieved April 5, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2019, February). Center for Drug Evaluation and Research. Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) injection, for subcutaneous use. Retrieved April 4, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761106Orig1s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 7/31/2019
MOST RECENT REVIEW DATE: 9/30/2019
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;