Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta™)
Requires Step Therapy See “Step Therapy Requirements for Provider Administered Specialty Medications” Document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Herceptin Hylecta is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer:
a. As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
b. As part of a treatment regimen with docetaxel and carboplatin
c. As a single agent following multi-modality anthracycline based therapy
2. Herceptin Hylecta is indicated in adults:
a. In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
b. As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
B. Compendial Uses
HER2-positive breast cancer: may be substituted for intravenous trastuzumab and used as a single agent or in combination with other systemic therapies
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of human epidermal growth factor receptor 2 (HER2) status is necessary to initiate the prior authorization review.
III. CRITERIA FOR INITIAL APPROVAL
Breast Cancer
1. Authorization of up to 12 months may be granted for adjuvant treatment of HER2-positive breast cancer.
2. Authorization of 12 months may be granted for treatment of HER2-positive breast cancer with no response to preoperative systemic therapy, recurrent, unresectable, advanced, or metastatic (including brain metastases) disease.
3. Authorization of up to 12 months may be granted for neoadjuvant treatment of HER2-positive breast cancer as part of a complete treatment regimen.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication outlined in section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen. Adjuvant and neoadjuvant treatment of breast cancer will be approved for a total of 12 months of therapy.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Herceptin Hylecta (Trastuzumab- Hyaluronidase-oysk) |
Breast Cancer |
Route of Administration: Subcutaneous 600/10,000mg-units every 3 weeks |
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.
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).
REFERENCES
1. Herceptin Hylecta [package insert]. South San Francisco, CA: Genentech, Inc.; February 2019.
2. The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed December 7, 2022.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 4.2022. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed December 7, 2022.
ORIGINAL EFFECTIVE DATE: 7/31/2019
MOST RECENT REVIEW DATE: 4/1/2024
ID_CHS
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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