CurrentViva HealthPolicy IC-0449

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Subcutaneous

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This Viva Health reimbursement policy governs prior authorization, dosing, coverage criteria, and billing information for Herceptin Hylecta (subcutaneous trastuzumab with hyaluronidase) for adults with HER2-positive breast cancer and affects Viva Health members and providers seeking coverage for this drug.

Policy Summary

PayerViva Health

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Subcutaneous

Policy CodePolicy IC-0449

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

Key ActionObtain prior authorization: initial approval valid 6 months (renew every 6 months; adjuvant use may be renewed up to 52 weeks) and document contraindication/intolerance/failure to listed trastuzumab biosimilars.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

600 mg / 10,000single subcutaneous dose strength

60max units / 21 days

6 monthsinitial PA validity

6 monthsrenewal interval

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CurrentViva HealthPolicy IC-0449

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Subcutaneous

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Policy Summary

PayerViva Health

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Subcutaneous

Policy CodePolicy IC-0449

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

600 mg / 10,000single subcutaneous dose strength

60max units / 21 days

6 monthsinitial PA validity

6 monthsrenewal interval

52 weeksadjuvant max

Coverage and Indications

Coverage criteria for Herceptin Hylecta

Coverage (prior authorization validity) is provided when initial and universal criteria are met for the specified HER2‑positive breast cancer indications.

ALL of the following

ALL of the following
- Member is at least 18 years of age
- Documented contraindication, intolerance, or failure to Kanjinti, Ogivri, AND Ontruzant prior to consideration of Herceptin Hylecta
- Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment
- HER2-positive disease as determined by an FDA-approved or CLIA-compliant test
- Females of reproductive potential have a negative pregnancy test prior to initiating treatment and will use effective contraception during treatment and for 7 months after the last dose
- Therapy will not be substituted with or for ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan-nxki (Enhertu); will not be used in combination with intravenous chemotherapy agents; and will not be used in combination with intravenous trastuzumab products or pertuzumab/trastuzumab and hyaluronidase-zzxf (Phesgo)
ANY of the following
- ALL of the following
  - Used as adjuvant therapy
  - Used as a single agent following anthracycline-based therapy or as part of listed regimens per FDA labeling
  - Prior authorization validity for adjuvant breast cancer may be renewed up to a maximum of 52 weeks of treatment
- ALL of the following
  - Used for metastatic disease
  - ANY of the following
    Used as a single agent in members who have received one or more prior chemotherapy regimens for metastatic disease

Covered Indications (ICD-10)

Covered diagnoses for Herceptin Hylecta are specified by the following ICD-10 codes for malignant neoplasms of the breast and related history codes.

ALL of the following

ICD-10 list: See Appendix 1 — Covered Diagnosis Codes (C50.* series and Z85.3) as listed in coding: includes C50.011–C50.029, C50.111–C50.129, C50.211–C50.229, C50.311–C50.329, C50.411–C50.429, C50.511–C50.529, C50.611–C50.629, C50.811–C50.829, C50.911–C50.929, C50.A0–C50.A2, and Z85.3

Initial Therapy Requirements

Initial therapy criteria

Prior authorization for initial therapy will be provided when ALL of the following initial and universal criteria are met:

ALL of the following

Member is at least 18 years of age
Documented contraindication, intolerance, or failure to Kanjinti, Ogivri, AND Ontruzant prior to consideration of Herceptin Hylecta
ALL of the following
- Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment
- Member has HER2‑positive disease as determined by an FDA‑approved or CLIA‑compliant test

Renewal and Continuation Criteria

Renewal/continuation therapy criteria

Renewal of prior authorization may be granted when ALL of the following continuation criteria are met:

ALL of the following

Member continues to meet the universal and indication‑specific criteria identified for initial approval
Duration of authorization has not been exceeded (see length of authorization; initial and renewal periods are 180 days; adjuvant treatment may be renewed up to a maximum of 52 weeks)
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug (examples include cardiotoxicity, pulmonary toxicity, neutropenia, severe administration‑related reactions)

Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization length and renewal

Prior authorization is required. Initial prior authorization validity will be provided for 6 months (180 days). Prior authorization may be renewed every 6 months (180 days) thereafter; for adjuvant breast cancer, prior authorization may be renewed up to a maximum of 52 weeks of treatment.

Initial: 6 months (180 days)
Renewal: every 6 months (180 days)
Adjuvant breast cancer: renewals up to a maximum of 52 weeks

Prior Authorization

Document prerequisite therapy and universal initial criteria

Obtain and document that the member is ≥18 years old and has a documented contraindication, intolerance, or failure to the trastuzumab biosimilars Kanjinti, Ogivri, AND Ontruzant prior to consideration of Herceptin Hylecta; also ensure all universal criteria are met (including LVEF within normal limits, HER2-positive disease by FDA- or CLIA-compliant test, pregnancy testing/contraception, and not combining with excluded agents).

Billing, Codes and Quantity Limits

HCPCS / NDC — Herceptin Hylecta (covered)HCPCS | NDCCovered

J9356	Injection, trastuzumab, 10 mg and hyaluronidase-oysk; 1 billable unit = 10 mg
50242-0077-xx	Herceptin Hylecta 600 mg/10,000 units single-dose vial (NDC)

Covered Diagnosis Codes — ICD-10ICD-10Covered

C50.011	Malignant neoplasm of nipple and areola, right female breast
C50.012	Malignant neoplasm of nipple and areola, left female breast
C50.019	Malignant neoplasm of nipple and areola, unspecified female breast
C50.021	Malignant neoplasm of nipple and areola, right female breast
C50.022	Malignant neoplasm of nipple and areola, left female breast
C50.029	Malignant neoplasm of nipple and areola, unspecified female breast
C50.111	Malignant neoplasm of central portion of right female breast
C50.112	Malignant neoplasm of central portion of left female breast
C50.119	Malignant neoplasm of central portion of unspecified female breast
C50.121	Malignant neoplasm of central portion of right male breast

1–10 of 58

1/6

inv-05: Maximum units per 21 days — quantity limit

Maximum quantity limit60 billable units every 21 days

Billing unit definitionHCPCS unit: 1 billable unit = 10 mg (J9356 defines 10 mg per unit)

Time windowLimit applies per 21-day (three-week) dosing interval

inv-06: Medicare Part B Covered Diagnosis Codes — Medicare-specific covered diagnosis code note

Medicare Part B covered diagnosis codesN/A — no specific Medicare Part B covered diagnosis codes listed in this policy

Guidance sourceMedicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50

Prior Failures and Biosimilar Step Requirements

Step	Requirement	Notes
1	Documented trial and failure, intolerance, or contraindication to the trastuzumab biosimilars Kanjinti, Ogivri, AND Ontruzant is required prior to coverage of Herceptin Hylecta.	Prior authorization will only be considered when documentation shows trial and failure/intolerance/contraindication to all three listed biosimilars.

Billing Rule

Required trial/failure of specified trastuzumab biosimilars

Before Herceptin Hylecta will be considered, the member must have documented contraindication, intolerance, or failure to Kanjinti, Ogivri, AND Ontruzant.

Administration and Place of Service

Note

Route and setting for administration

Herceptin Hylecta must be administered by a health care professional subcutaneously in the thigh only; do not administer intravenously.

Key Definitions and Notes

inv-11: Route of administration

Route of administrationAdminister subcutaneously in the thigh by a health care professional only

Not for IV useDo not administer intravenously; formulation intended for subcutaneous use only

Dose and frequencyAdminister 600 mg trastuzumab + 10,000 units hyaluronidase subcutaneously every three weeks

inv-12: HER2-positive

IHC criterionImmunohistochemistry (IHC) assay 3+

Primary ISH criterionDual-probe ISH HER2/CEP17 ratio ≥ 2.0 AND average HER2 copy number ≥ 4.0 signals/cell

Combined IHC/ISH scenarios

Policy Summary

PayerViva Health

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) — Subcutaneous

Policy CodePolicy IC-0449

Change TypeNo material changes

Effective DateJun 2, 2026

Last ReviewJun 2, 2026

Next Review DateJun 2, 2026

SourceLink

On This Page

Used in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer per FDA labeling

Females of reproductive potential have a negative pregnancy test prior to initiating treatment and will use effective contraception during treatment and for 7 months after the last dose

Therapy will not be substituted with or for ado‑trastuzumab emtansine (Kadcyla) or fam‑trastuzumab deruxtecan‑nxki (Enhertu); will not be used in combination with intravenous chemotherapy agents; and will not be used in combination with intravenous trastuzumab products or pertuzumab/trastuzumab and hyaluronidase‑zzxf (Phesgo)

ANY of the following

ALL of the following
- Used as adjuvant therapy
- Used as a single agent following anthracycline‑based therapy or as part of listed regimens per FDA labeling
ALL of the following
- Used for metastatic disease
- ANY of the following
  - Used as a single agent in members who have received one or more prior chemotherapy regimens for metastatic disease
  - Used in combination with paclitaxel for first‑line treatment of HER2‑overexpressing metastatic breast cancer per FDA labeling

Left ventricular ejection fraction (LVEF) within the previous 3 months is within institutional normal limits and has not had an absolute decrease of ≥ 16% from pre‑treatment baseline; OR LVEF below institutional lower limits and has not had an absolute decrease of ≥ 10% from pre‑treatment baseline

Documented contraindication, intolerance, or failure to Kanjinti, Ogivri, AND Ontruzant

Confirm LVEF within normal limits and regular assessments (e.g., every 3 months)

Confirm HER2-positive per FDA- or CLIA-compliant test

Negative pregnancy test and effective contraception during treatment and for 7 months after last dose

Do not substitute for Kadcyla or Enhertu; do not combine with IV chemotherapy, IV trastuzumab products, or Phesgo

Prior Authorization

Renewal documentation and clinical criteria

For renewal, document that the member continues to meet the universal and indication‑specific criteria, that the duration of authorization has not been exceeded, and that there is disease response without unacceptable toxicity; include a recent LVEF (within the previous 3 months) showing values within institutional limits and not decreased beyond specified absolute drops from baseline.

Member continues to meet universal and indication‑specific criteria
Duration of authorization not exceeded (see Length of Authorization)
Disease response: stabilization or decrease in tumor size/spread
Absence of unacceptable toxicity (e.g., cardiotoxicity, pulmonary toxicity, neutropenia, severe administration reactions)
Recent LVEF within previous 3 months — within institutional normal limits and not decreased ≥16% from baseline, or if below institutional lower limit, not decreased ≥10% from baseline

Note

Appendix A — NQTL factor checklist must be considered

Include Appendix A NQTL Factor Checklist considerations in prior authorization decisions — the policy documents that indication, safety/efficacy, and drug cost were factors to consider for PA, while potential for misuse/abuse was not prioritized.

Factors considered: Indication (Consider for PA); Safety and efficacy (Consider for PA); Cost of drug (Consider for PA); Potential for misuse/abuse (PA not a priority)

Local/National determinationsNational Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may apply; check CMS coverage database

inv-18: Herceptin Hylecta (trastuzumab component, billed J9356)

Quantity limit (trastuzumab component billed J9356)60 billable units every 21 days (policy quantity limit)

HCPCS billing code and unitJ9356 — Injection, trastuzumab, 10 mg and hyaluronidase-oysk; 1 billable unit = 10 mg

Single-dose vial strength (NDC)Herceptin Hylecta 600 mg / 10,000 units single-dose vial (NDC 50242-0077-xx)

Acceptable when ISH and concurrent IHC meet specified combinations (e.g., ratio ≥2.0 with avg copy <4.0 and IHC 3+; ratio <2.0 with avg copy ≥6.0 and IHC 2+ or 3+; or ratio <2.0 with avg copy ≥4.0 and <6.0 with IHC 3+)

inv-13: Non-Quantitative Treatment Limitations (NQTLs)

DefinitionNon-quantitative treatment limitations (NQTLs) are methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan.

ExamplesMay include utilization review or prior authorization and other utilization management methods

ApplicationNQTLs applied comparably to MH/SUD and M/S medical benefit prescription drugs; factors considered are listed in Appendix A (indication, safety/efficacy, misuse/abuse potential, cost)

inv-14: Medicare/ CMS coverage guidance

Medicare Part B guidanceMedicare coverage for outpatient (Part B) drugs is governed by the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals

Potential NCD/LCD applicabilityNational Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs) may exist and must be followed where applicable

CMS search resourceSearch for NCD/LCD/LCA documents at the CMS Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/search.aspx