Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta)
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Defines coverage, prior authorization, quantity limits, and treatment duration for Herceptin Hylecta (subcutaneous trastuzumab with hyaluronidase) for BCBS Tennessee members with HER2-positive breast cancer and specified compendial uses.
No material clinical or coverage changes in this revision.
Coverage Criteria
Covered Indications
Covered when ALL of the following are met
See FDA‑Approved Indications and Compendial Uses sections
Continuation of Therapy
Covered for continuation when ALL of the following are met
Authorization of up to 12 months may be granted for continued treatment
All indications not explicitly listed as covered in this policy — that is, uses outside FDA-approved indications and listed compendial uses — are considered experimental/investigational and are not medically necessary.
Uses of Herceptin Hylecta that are not supported by FDA labeling or recognized compendia are not medically necessary and will not be authorized.
Initial Therapy Authorization
Initial Therapy Authorization
Authorization durations for initial therapy by setting
See clinical setting-specific indications in FDA‑Approved Indications and policy rationale
Continuation / Reauthorization
Continuation/Reauthorization
Reauthorization rules for members already on therapy
Applies to members already receiving therapy who meet continuation criteria
Coding and Quantity
| 600/10,000 mg-units every 3 weeks | Maximum dosing regimen for subcutaneous administration as listed in Medication Quantity Limits |
Provider Actions and Requirements
Prior Authorization Required
Prior authorization is required. Providers must follow the Step Therapy requirements for provider-administered specialty medications as referenced.
- See external guide: Step Therapy Requirements for Provider Administered Specialty Medications
Step Therapy Requirement
Step Therapy applies as specified in the external 'Step Therapy Requirements for Provider Administered Specialty Medications' guide. Providers should consult the referenced document for step edits and eligible agents prior to submission.
Required Documentation
Submission of HER2 status (human epidermal growth factor receptor 2) is required to initiate prior authorization review.
- Required: HER2 status (test report or pathology note)
Experimental/Investigational Exclusions
All indications other than HER2-positive breast cancer and compendial uses listed are considered experimental/investigational and are not medically necessary.
- Covered/appropriate use: HER2-positive breast cancer (may be substituted for IV trastuzumab)
- Not medically necessary: All other indications
Step Therapy
| Requirement | Details |
|---|---|
| Step Therapy requirement | Step Therapy is required per BCBS TN 'Step Therapy Requirements for Provider Administered Specialty Medications' document (see: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf) |
Quantity Limits
Site of Care
Infusion center — follow provider-administered Step Therapy rules
Provider-administered specialty medication policies, including Step Therapy requirements, apply to infusion center settings; follow the BCBS TN Step Therapy guide for site-specific requirements.
- Site-of-care rules and Step Therapy requirements from the BCBS TN guide must be followed for infusion center administration.
Definitions
Background
Herceptin Hylecta (subcutaneous trastuzumab with hyaluronidase) is indicated for treatment of HER2-positive breast cancer including situations where it may be substituted for intravenous trastuzumab and used as a single agent or in combination with other systemic therapies. Documentation of HER2 status is required per policy to support prior authorization review.
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