BlueCross BlueShield of Tennessee Medical Policy Manual

Trastuzumab and Hyaluronidase-oysk

NDC CODE(S)

50242-0077-XX Herceptin Hylecta 600 MG - 10,000 MG UNT/5ML SOLN (GENENTECH, INC)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

*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

 

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Breast Cancer

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.

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).

SOURCES

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

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.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit;

DIAGNOSIS

MAXIMUM UNITS

Breast Cancer

 600 mg/10,000 units every 21 days