CurrentCareSourcePolicy N/A

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection coverage

Defines medical necessity and prior authorization criteria for Herceptin Hylecta for adult patients with HER2-positive breast cancer in adjuvant, recurrent, or metastatic settings and describes dosing, prescriber requirements, and non-covered situations.

Policy Summary

PayerCareSource

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection coverage

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests for Herceptin Hylecta and ensure prescribing is by or in consultation with an oncologist; requests for doses outside the documented dosing will be reviewed case-by-case by a clinician.

SourceLink

POLICY UPDATE CHANGES

Annual revision noted with no criteria changes.

600 mg / 10,000 unitsStandard Herceptin Hylecta dose

every 3 weeksDosing frequency

1 yearTypical authorization duration (adjuvant or metastatic)

>= 18Minimum patient age for approval

Medical Necessity Criteria for Herceptin Hylecta

Policy Summary

PayerCareSource

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection coverage

Policy CodePolicy N/A

Change TypeAnnual revision — no criteria changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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FDA-Approved Indication — Breast Cancer

Approve for the duration noted below if the patient meets ALL of the following criteria (A, B, C, and D):

ALL of the following

Patient is >= 18 years of age>= 18 years
ONE of the following disease settings
- Adjuvant treatment
  Approve for 1 year (total) if used for adjuvant treatment
- Recurrent or metastatic disease
  Approve for 1 year if for recurrent or metastatic disease
Patient has HER2-positive disease
HER2 overexpressing disease per standard diagnostic testing
Medication is prescribed by or in consultation with an oncologist
Specialist involvement required due to evaluation, monitoring, and management complexity

Dosing: 600 mg trastuzumab and 10,000 units hyaluronidase (Herceptin Hylecta) administered subcutaneously once every 3 weeks.

Dosing and Billing Codes

Medication dosing (documented dosing for approval)mixedCovered

Dose	600 mg trastuzumab and 10,000 units hyaluronidase (Herceptin Hylecta) administered subcutaneously once every 3 weeks

Key thresholds and dosing quick reference

Minimum age>= 18 years

Standard dose (per administration)600 mg trastuzumab + 10,000 units hyaluronidase (Herceptin Hylecta)

Dosing frequencyAdministered subcutaneously once every 3 weeks

Typical authorization durationApprove for 1 year (adjuvant or recurrent/metastatic settings)

Authorization and Prescribing Requirements

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for medical benefit coverage of Herceptin Hylecta; requests for doses outside the established dosing will be considered case-by-case by a clinician (Medical Director or Pharmacist).

Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Documentation Required

Specialist involvement required

Herceptin Hylecta must be prescribed by or in consultation with a physician who specializes in the condition treated (oncologist) due to the specialized evaluation, monitoring for adverse events, and long-term efficacy requirements.

Prescriber must be or consult an oncologist.
Required because of specialized skills for evaluation, diagnosis, and monitoring of patients treated with Herceptin Hylecta.

Clinical Context

Herceptin Hylecta is a subcutaneous formulation of trastuzumab with hyaluronidase indicated for adults with HER2-overexpressing (HER2-positive) breast cancer. The recommended dosing in this policy is 600 mg trastuzumab and 10,000 units hyaluronidase administered subcutaneously once every 3 weeks. Approval is limited to adults aged >= 18 years and to the disease settings listed (adjuvant, recurrent, or metastatic) with typical authorization durations noted in the criteria.

Per the NCCN Breast Cancer Guidelines, Herceptin Hylecta may be substituted for intravenous trastuzumab and used as a single agent or in combination with other systemic therapies; however, because the product has a different dose and dosage form it is specifically not substitutable for ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan (Enhertu). Use must be by or in consultation with an oncologist due to required evaluation, monitoring for adverse events, and long-term efficacy.

Defined Terms

Definitions

Her2-positiveBreast cancers that overexpress the human epidermal growth factor receptor 2 (HER2) as determined by standard testing (IHC/FISH) indicating eligibility for trastuzumab therapy.

Adjuvant treatmentTherapy given after primary treatment (e.g., surgery) to reduce risk of cancer recurrence.

Non-covered Situations

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Requests that fall outside the listed criteria will not be approved under this policy. The policy will be updated as new published data become available, and dosing or coverage criteria may be revised accordingly.

Policy Updates

2024-03-20clarifiedLatest

Annual revision noted with no criteria changes; document history lists annual reviews with the most recent on 03/20/2024.

Source Documents

Genentech. Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection — prescribing information; February 2019.

National Comprehensive Cancer Network (NCCN). The NCCN Breast Cancer Clinical Practice Guidelines in Oncology, version 2.2024; March 11, 2024.