Currentculinary health fundPolicy N/A

Herceptin Hylecta (trastuzumab and hyaluronidase) subcutaneous injection — Coverage Criteria

Policy governs prior authorization and medical benefit coverage criteria for Herceptin Hylecta for adult patients with HER2-positive breast cancer, including adjuvant and metastatic uses, for members of Culinary Health Fund.

Policy Summary

Payerculinary health fund

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase) subcutaneous injection — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateMar 4, 2026

Key ActionObtain prior authorization and document oncologist prescribing or consultation; approve when the patient meets the recommended authorization criteria and dosing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18min age

600 mg/10,000 unitsdose per admin

q3winterval

1 yearmax approval duration

Coverage Criteria for Herceptin Hylecta

Policy Summary

Payerculinary health fund

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase) subcutaneous injection — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateMar 4, 2026

Key ActionObtain prior authorization and document oncologist prescribing or consultation; approve when the patient meets the recommended authorization criteria and dosing.

SourceLink

On This Page

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Main criteria: A) Patient is ≥ 18 years of age;

Minimum age requirement per FDA-approved indication.

Main criteria: B) Patient has HER2-positive disease (as documented in the medical record).

Main criteria

i or ii: i. Adjuvant setting: approve for up to 1 year (total).
Used as part of adjuvant regimens described in product labeling (see regimens).
i or ii: ii. Recurrent or metastatic disease: approve for 1 year.
Includes first-line metastatic combination with paclitaxel or single-agent use after prior chemotherapy regimens as per FDA labeling.

Main criteria: D) Medication is prescribed by or in consultation with an oncologist.

Dosing and administration: Dosing: 600 mg trastuzumab + 10,000 units hyaluronidase (Herceptin Hylecta) administered subcutaneously once every three weeks (q3w).

Requests for doses outside this regimen will be considered case-by-case by a clinician.

Regimen scenario	Authorization notes
Doxorubicin + cyclophosphamide followed by paclitaxel or docetaxel (Herceptin Hylecta used as part of this multi-agent adjuvant regimen)	Approve for adjuvant use for up to 1 year total when patient meets all policy criteria (adult with HER2‑positive disease; prescribed by or in consultation with an oncologist).
Docetaxel + carboplatin with Herceptin Hylecta as part of the adjuvant regimen	Approve for adjuvant use for up to 1 year total when patient meets all policy criteria (adult with HER2‑positive disease; prescribed by or in consultation with an oncologist).
Single‑agent Herceptin Hylecta following multi‑modality anthracycline‑based therapy (post‑anthracycline single‑agent use)	Approve for adjuvant single‑agent use for up to 1 year total when patient meets all policy criteria (adult with HER2‑positive disease; prescribed by or in consultation with an oncologist).

Metastatic scenario	Authorization notes
Combination with paclitaxel for first‑line metastatic treatment	Approve for first‑line metastatic use when patient meets policy criteria (adult with HER2‑positive disease; prescribed by or in consultation with an oncologist).
Single‑agent Herceptin Hylecta for patients who have received one or more prior chemotherapy regimens for metastatic disease	Approve for single‑agent metastatic use when patient meets policy criteria (adult with HER2‑positive disease; prescribed by or in consultation with an oncologist).

Line of Therapy Specifications

first-line | adjuvant | later-line

Lines mentioned: Adjuvant (as part of multi-agent regimens or single-agent following anthracycline-based therapy), first-line metastatic (in combination with paclitaxel), and subsequent-line metastatic single-agent use are supported per FDA indications and NCCN guidance.

Adjuvant examples: with doxorubicin + cyclophosphamide + paclitaxel/docetaxel; with docetaxel + carboplatin; or single-agent after anthracycline-based therapy. Metastatic examples: in combination with paclitaxel for first-line metastatic treatment, or as single agent after prior chemotherapy regimens.

Biomarker and Diagnostic Requirements

HER2 — documentation requirement

RequirementHER2-positive disease must be documented in the medical record for coverage.

Supporting criterionHER2 positivity is listed as a required criterion in the FDA‑approved indication for breast cancer coverage (policy requires patient has human epidermal growth factor receptor 2 (HER2)-positive disease).

Documentation expectationDocumentation should clearly indicate HER2‑positive status (e.g., pathology or test report) in the medical record to meet the biomarker requirement.

HER2-positive disease — definition

DefinitionHER2-positive disease: breast tumors overexpressing human epidermal growth factor receptor 2 (HER2), qualifying patients for trastuzumab-based therapy.

Policy thresholdHER2-positive is required for all covered breast cancer indications in this policy (adjuvant and metastatic).

Clinical implicationHER2 positivity enables use of Herceptin Hylecta as single agent or in combination per FDA‑approved regimens and NCCN guidance.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of Herceptin Hylecta. Approval is recommended only for patients who meet the policy's Recommended Authorization Criteria and documented dosing. Extended approvals are allowed if the patient continues to meet criteria. Requests for doses outside the established dosing will be reviewed case-by-case by a clinician (Medical Director or Pharmacist).

Prior authorization recommended for medical benefit coverage
Approvals granted only for patients meeting policy criteria and dosing
Extended approvals permitted when criteria continue to be met
Off-label or non‑standard dosing requests reviewed case‑by‑case by clinician

Note

Substitution / Non‑Substitution Guidance

Herceptin Hylecta may be substituted for intravenous trastuzumab formulations (per NCCN guidance) but note the different dose and subcutaneous dosage form. Herceptin Hylecta explicitly cannot be substituted for ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan-nxki (Enhertu).

May substitute for trastuzumab intravenous products when clinically appropriate
Do NOT substitute for ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan-nxki (Enhertu)

Documentation Required

Prescriber and Dosing Documentation

Because of the specialized evaluation and monitoring required, Herceptin Hylecta must be prescribed by or in consultation with an oncologist. Documentation must include the prescribing oncology provider or documented oncology consult. For off‑label, non‑standard, or dosing outside the policy's established regimen, include supporting clinical rationale and relevant records; these requests will be reviewed by a clinician and may be denied if documentation is insufficient or criteria are not met.

Prescriber requirement: oncologist or documented oncology consultation
For off‑label or non‑standard dosing include clinical rationale and supporting records
Requests for non‑standard dosing reviewed by Medical Director or Pharmacist

Denial Risk

Denial Trigger

Requests that do not meet the Recommended Authorization Criteria or established dosing are not recommended for approval and are at high risk of denial.

Denial risk for requests outside the policy's criteria or lacking required documentation
Coverage not recommended for circumstances not listed in the Recommended Authorization Criteria

Covered Regimens and Combinations

Adjuvant regimen	Coverage notes
Doxorubicin + cyclophosphamide followed by paclitaxel or docetaxel (Herceptin Hylecta as part of regimen)	Covered for adjuvant treatment; approve up to 1 year total when all policy criteria are met (adult with HER2‑positive disease; oncologist involvement required).
Docetaxel + carboplatin with Herceptin Hylecta	Covered for adjuvant treatment; approve up to 1 year total when all policy criteria are met (adult with HER2‑positive disease; oncologist involvement required).
Single‑agent Herceptin Hylecta following multi‑modality anthracycline‑based therapy	Covered as single‑agent adjuvant therapy after anthracycline‑based therapy; approve up to 1 year total when all policy criteria are met (adult with HER2‑positive disease; oncologist involvement required).

Metastatic regimen	Line‑of‑therapy context / Coverage notes
Herceptin Hylecta in combination with paclitaxel	Covered as first‑line treatment for metastatic HER2‑positive breast cancer when policy criteria are met (adult patient; oncologist involvement required).
Single‑agent Herceptin Hylecta after prior chemotherapy regimens	Covered for treatment of metastatic disease in patients who have received one or more prior chemotherapy regimens when policy criteria are met (adult patient; oncologist involvement required).

Background

Herceptin Hylecta is a subcutaneous formulation combining trastuzumab with hyaluronidase administered as a fixed-dose injection (600 mg trastuzumab + 10,000 units hyaluronidase per dose, given every three weeks) for the treatment of adult patients with HER2-positive breast cancer. It is indicated for both adjuvant and metastatic settings and, per guideline guidance, may be used as an alternative to intravenous trastuzumab though it differs in formulation and dosing and is not interchangeable with antibody–drug conjugates such as ado‑trastuzumab emtansine (Kadcyla) or fam‑trastuzumab deruxtecan (Enhertu).

Coding and Billing Notes

Covered HCPCS/NDC/CPT CodesmixedCovered

(no specific HCPCS/CPT/NDC codes listed)

Policy defines medical necessity and dosing for Herceptin Hylecta but does not list specific billing codes in the document.

Neutral / Policy Dosing Details (not billing codes)mixed

Dose	600 mg trastuzumab + 10,000 units hyaluronidase (600 mg/10,000 units) administered subcutaneously once every three weeks.
Age	Patient must be ≥ 18 years of age for coverage.
Maximum duration	Approve up to 1 year for adjuvant use; approve 1 year for recurrent or metastatic disease.

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