Currentmoda_health_plan_incPolicy N/A

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) (Subcutaneous) coverage criteria

Customize your policy alerts

Sign up for all moda_health_plan_inc policy alerts

Know when moda_health_plan_inc releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines prior authorization, dosing, authorization length, and medical necessity criteria for Herceptin Hylecta (subcutaneous) for adults with HER2-positive breast cancer for Moda Health Plan providers and reviewers.

Policy Summary

Payermoda_health_plan_inc

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) (Subcutaneous) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewAug 5, 2025

Next Review DateMay 1, 2026

Key ActionPrior authorization is required; initial validity 6 months (180 days) and renewals every 6 months, approvals only if patient is >=18 and meets listed criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60max HCPCS units /21 days

180 daysinitial PA validity

52 weeksmax adjuvant renewal

>=18min patient age

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

Currentmoda_health_plan_incPolicy N/A

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) (Subcutaneous) coverage criteria

Customize your policy alerts

Sign up for all moda_health_plan_inc policy alerts

Know when moda_health_plan_inc releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

Payermoda_health_plan_inc

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) (Subcutaneous) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewAug 5, 2025

Next Review DateMay 1, 2026

Key ActionPrior authorization is required; initial validity 6 months (180 days) and renewals every 6 months, approvals only if patient is >=18 and meets listed criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

60max HCPCS units /21 days

180 daysinitial PA validity

52 weeksmax adjuvant renewal

>=18min patient age

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial requirements: Member is >= 18 years of age; baseline left ventricular ejection fraction (LVEF) within institutional normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment; documented 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 last dose; therapy will not be substituted with ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan-nxki (Enhertu); therapy will not be used in combination with intravenous chemotherapy agents; therapy will not be used in combination with trastuzumab (or any of its biosimilar products) or pertuzumab/trastuzumab and hyaluronidase-zzxf (Phesgo).

Indication-specific (Breast Cancer): Either: (1) Adjuvant therapy: used as adjuvant therapy for members with ≥ T1 disease, node-positive disease, or inflammatory disease, and used as a single agent following anthracycline-based therapy; OR (2) Metastatic disease: used as a single agent in members who have received one or more prior chemotherapy regimens for metastatic disease.

Prior authorization validity will NOT encompass all FDA approved indications — only when above criteria are met.

Initial Therapy Criteria — Herceptin Hylecta

Initial coverage criteria for Herceptin Hylecta:

Age and baseline: Member is ≥ 18 years of age; baseline LVEF within institutional normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months).

HER2 confirmation: Documented HER2-positive disease as determined by an FDA-approved or CLIA-compliant test per accepted IHC/ISH criteria.

Clinical use setting: Adjuvant therapy meeting tumor/node criteria and single-agent use following anthracycline-based therapy OR metastatic single-agent use after one or more prior chemotherapy regimens.

Prior authorization validity will be provided only when these indication-specific criteria are met.

Exclusion: Herceptin Hylecta must not be administered in combination with intravenous trastuzumab products (including trastuzumab biosimilars) or with pertuzumab/trastuzumab and hyaluronidase-zzxf (Phesgo). This therapy also must not be substituted with or for ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan‑nxki (Enhertu), nor used in combination with intravenous chemotherapy agents.

Medicare coverage rules may differ from this policy. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) for Medicare Part B drugs may apply and must be followed where applicable. This document is intended to support non‑Medicare coverage determinations; providers should consult the CMS Coverage Database and applicable Medicare guidance when assessing Medicare members.

Prior authorization under this policy is limited to the specific adjuvant and metastatic indications and criteria described herein. Prior authorization validity will NOT encompass all FDA‑approved indications; uses outside the specified adjuvant/metastatic criteria (as detailed in the Initial Therapy section) are not authorized under this policy.

Initial Therapy Criteria

Initial Therapy Criteria — Herceptin Hylecta

Initial coverage criteria for Herceptin Hylecta:

Universal criteria: Left ventricular ejection fraction (LVEF) is within institutional normal limits prior to initiating therapy and will be assessed at regular intervals; 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 last dose; therapy must not be substituted with Kadcyla or Enhertu; therapy must not be used in combination with IV chemotherapy or with IV trastuzumab products or pertuzumab/trastuzumab with hyaluronidase (Phesgo).

Breast cancer indications: Either: (1) Adjuvant — used as adjuvant therapy for members with ≥ T1 disease, node-positive disease, or inflammatory disease, and used as single agent following anthracycline-based therapy; OR (2) Metastatic — used as single agent in members who have received one or more prior chemotherapy regimens for metastatic disease.

Initial/Adjuvant therapy — Adjuvant therapy guidance

Adjuvant therapy guidance:

Continuation / Renewal Criteria

Continuation Therapy / Renewal

Renewal provided when ALL of the following are met:

Renewal requirements: Member continues to meet the universal and indication-specific criteria identified for initial approval; duration of authorization has not been exceeded; disease response demonstrated as stabilization or decrease in tumor size or spread; absence of unacceptable toxicity (examples include cardiotoxicity, pulmonary toxicity, neutropenia, severe administration-related reactions); and LVEF within the previous 3 months meets institutional normal limits and has not decreased ≥16% from baseline, OR if below institutional lower limit has not decreased ≥10% from baseline.

Duration of therapy — Renewal/continuation rules

Renewal/continuation rules:

Duration rules: Adjuvant therapy: administer for 52 weeks or until disease recurrence; Metastatic breast cancer: administer until disease progression.

Continuation therapy — Duration guidance

Coding and Diagnosis

Covered HCPCS CodesHCPCSCovered

J9356

Injection, trastuzumab, 10 mg and hyaluronidase-oysk; 1 billable unit = 10 mg

NDC (product availability)NDC

50242-0077-xx

Herceptin Hylecta 600 mg/10,000 units (providing 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL) single-dose vials

Drug HCPCSHCPCS

HCPCS Code:

HCPCS code label shown in document (specific code value not present in this excerpt)

Covered ICD-10 Diagnosis CodesICD-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

HCPCS units per dose

Maximum HCPCS units per dose60 billable units every 21 days

Adjuvant therapy duration

Adjuvant therapy duration52 weeks (or until disease recurrence)

Quantity Limits

Herceptin Hylecta — per-dose billing

Per-dose billing quantity60 billable units per dose (1 billable unit = 10 mg; Herceptin Hylecta vial provides 600 mg trastuzumab / 10,000 units hyaluronidase)

HCPCS codeJ9356 - Injection, trastuzumab, 10 mg and hyaluronidase-oysk

NDC (product presentation)Herceptin Hylecta 600 mg/10,000 units single-dose vial: 50242-0077-xx

Provider Actions and Prior Authorization

Prior Authorization

Prior authorization required; initial 180 days, renewals every 180 days

Prior authorization is required for Herceptin Hylecta. Initial approvals are valid for 6 months (180 days); renewals may be issued every 6 months (180 days) thereafter. Adjuvant breast cancer treatment may be renewed up to a maximum of 52 weeks of treatment. Approvals are provided only if the patient is ≥18 years of age and meets the listed coverage criteria.

Initial PA validity: 6 months (180 days)
Renewals: every 6 months (180 days)
Adjuvant therapy renewal limit: up to 52 weeks
Patient must be ≥18 and meet coverage criteria

Prior Authorization

PA considered due to NQTL factors (indication, safety/efficacy, cost)

Prior authorization is considered based on non-quantitative treatment limitation (NQTL) factors including indication, safety and efficacy, and drug cost. These NQTL factors were evaluated and cited as reasons to apply PA to this drug.

Step Therapy / Substitution Rules

Requirement	Details
Therapy substitution restriction
Therapy must not be substituted with or for ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan‑nxki (Enhertu).

Prior authorization consideration	Notes
NQTL-based consideration
Prior authorization may be considered based on non‑quantitative treatment limitation (NQTL) factors including indication, safety/efficacy, and drug cost as listed in the NQTL checklist.

Site of Care and Administration

Billing Rule

Administer subcutaneously in the thigh by a health care professional; do not give IV

Administer Herceptin Hylecta only by a health care professional as subcutaneous injection in the thigh; do not administer intravenously.

Subcutaneous use only; administer in the thigh
Do not administer IV

Billing Rule

Medicare Part B site-of-care and billing rules may differ; verify applicable Medicare policies

Medicare Part B site‑of‑care and billing rules may differ for outpatient/Part B drugs; check applicable Medicare policies, NCDs/LCDs/LCAs and MAC jurisdiction rules when billing Medicare patients.

Medicare coverage and billing may be governed by NCD/LCD/LCA and CMS manuals
Verify applicable MAC jurisdiction and Medicare policies prior to billing

Definitions

HER2‑positive definition

IHC criterionImmunohistochemistry (IHC) assay 3+

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

Alternate combined ISH/IHC permutationsISH ratio ≥2.0 with average HER2 <4.0 signals/cell plus concurrent IHC 3+, OR ISH ratio <2.0 with average HER2 ≥6.0 signals/cell plus concurrent IHC 2+ or 3+, OR average HER2 4.0–<6.0 with concurrent IHC 3+

Adjuvant therapy

DefinitionAdjuvant therapy: systemic therapy given after primary treatment to reduce recurrence risk; here specified as 52 weeks or until recurrence

Typical settingUsed following surgery and, when indicated, as single agent after anthracycline-based therapy

Background

Herceptin Hylecta is a fixed‑dose subcutaneous formulation combining trastuzumab with hyaluronidase for administration every three weeks for HER2‑positive breast cancer. It is indicated for adjuvant and metastatic use consistent with FDA labeling, but prior authorization and medical necessity determinations follow the criteria in this policy (including age, documented HER2‑positive status, baseline LVEF within institutional normal limits, and other universal requirements).

Policy Summary

Payermoda_health_plan_inc

PolicyHerceptin Hylecta (trastuzumab and hyaluronidase-oysk) (Subcutaneous) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Last ReviewAug 5, 2025

Next Review DateMay 1, 2026

Key ActionPrior authorization is required; initial validity 6 months (180 days) and renewals every 6 months, approvals only if patient is >=18 and meets listed criteria.

SourceLink

On This Page

Adjuvant duration: Adjuvant therapy: administer for 52 weeks or until disease recurrence.52 weeks

Duration guidance for ongoing therapy:

Metastatic duration: For metastatic breast cancer: administer until disease progression.

NQTL factors considered: indication; safety and efficacy; cost

Step Therapy

Do not substitute or combine with specified HER2 agents or IV chemotherapy

Herceptin Hylecta must not be substituted with ado-trastuzumab emtansine (Kadcyla) or fam-trastuzumab deruxtecan‑nxki (Enhertu), and must not be used in combination with intravenous chemotherapy agents, IV trastuzumab (or biosimilars), or pertuzumab/trastuzumab with hyaluronidase (Phesgo).

Do not substitute with Kadcyla (ado‑trastuzumab emtansine) or Enhertu (fam‑trastuzumab deruxtecan‑nxki)
Do not combine with IV chemotherapy agents
Do not combine with IV trastuzumab products or pertuzumab/trastuzumab with hyaluronidase (Phesgo)

Documentation Required

Provide HER2 test results and baseline LVEF with regular reassessment

Documentation must include evidence of HER2‑positive status using the specified IHC or ISH criteria and a baseline left ventricular ejection fraction (LVEF) within institutional normal limits prior to initiating therapy; LVEF should be assessed at regular intervals during treatment.

HER2-positive confirmation per IHC 3+ or ISH criteria as specified
Baseline LVEF within institutional normal limits and regular interval assessments (e.g., every 3 months)

Documentation Required

Include a supported ICD-10 diagnosis (C50.xxx or Z85.3)

Submit documentation that supports a covered diagnosis code from the policy (malignant neoplasm of breast C50.xxx) or personal history of malignant neoplasm of breast (Z85.3) as applicable to the member's clinical indication.

Use an appropriate ICD-10 code from the covered list (C50.xxx) or Z85.3

Denial Risk

Missing required baseline assessments may lead to denial

Requests lacking universal baseline assessments may be denied. Examples include missing documentation of normal baseline LVEF, absent HER2‑positive status confirmed by an FDA‑approved or CLIA‑compliant test, or missing female reproductive precautions.

Normal baseline LVEF not documented
HER2-positive status not documented by FDA‑approved or CLIA‑compliant test
Missing negative pregnancy test or contraception plan for females of reproductive potential

Note

PA rationale includes indication, safety/efficacy, and cost (NQTL)

Prior authorization may be applied because of indication, safety/efficacy concerns, and drug cost as noted in the policy’s NQTL factor checklist; include rationale and supporting documentation when submitting PA requests.

NQTL checklist factors: indication; safety and efficacy; cost

Note

Reserved

Reserved.

Authorization noteDuration limited to 52 weeks per policy guidance

Metastatic therapy duration

Metastatic therapy durationFor metastatic breast cancer: administer until disease progression

Use contextUsed as single-agent in members who have received one or more prior chemotherapy regimens for metastatic disease

Guideline sourceDuration guidance referenced to NCCN guidelines (accessed May 2026)