Viva Health trastuzumab Coverage & Prior Auth

Coverage Criteria for Trastuzumab and Biosimilars

Initial Approval - Universal Criteria

Covered when ALL of the following are met:

Universal prerequisites: Patient is at least 18 years of age; patient has documented contraindication, intolerance, or failure to Kanjinti, Ogivri, AND Ontruzant prior to consideration of another trastuzumab product; baseline left ventricular ejection fraction (LVEF) is within institutional normal limits with a plan for regular assessment (e.g., every 3 months) during treatment; HER2-positive disease confirmed 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); therapy will not be used in combination with trastuzumab and hyaluronidase or pertuzumab/trastuzumab hyaluronidase combinations.age >=18

Initial authorization requires prior biosimilar trial/failure per policy.

Breast Cancer - Indication-specific Criteria

Covered for breast cancer when ANY of the following indication-specific pathways are met in addition to universal criteria:

Adjuvant therapy: Used as adjuvant therapy for patients with ≥T1 disease, node‑positive disease, or inflammatory disease; may be given with a taxane‑based regimen (with pertuzumab for pT2‑3 and pN0 or pN+ only), without pertuzumab, with pertuzumab alone, or as single‑agent trastuzumab; may be given after completion of planned chemotherapy following surgery when patient has ≥ ypT0N0 or pCR by axillary staging.

May be renewed up to 52 weeks for neoadjuvant/preoperative and adjuvant settings per Section I.

Neoadjuvant/preoperative therapy: Used as neoadjuvant/preoperative therapy for patients with ≥T1c disease, node‑positive disease, or inflammatory disease; used in combination with a taxane‑based regimen with or without pertuzumab.

Recurrent/metastatic or inflammatory disease: Used for recurrent unresectable (local or regional) or metastatic disease or inflammatory breast cancer: may be used as single agent in patients who have received one or more prior chemotherapy regimens for metastatic disease, or in combination regimens (e.g., paclitaxel first‑line for metastatic disease; pertuzumab + taxane first‑line; capecitabine + tucatinib second‑line; endocrine combinations for HR+ disease with menopausal/ovarian suppression considerations; later‑line agents per policy sequencing including neratinib, fulvestrant, lapatinib, cytotoxic chemotherapy as indicated).

CNS Cancers

Covered for CNS metastases when ALL of the following are met:

Leptomeningeal metastases: Patient has leptomeningeal metastases from breast cancer AND trastuzumab will be administered intrathecally or intraventricularly AND used as primary treatment in patients with good‑risk status (KPS ≥60, no major neurologic deficits, minimal systemic disease and reasonable systemic treatment options) OR used as maintenance therapy in patients with negative CSF cytology or clinically stable patients with persistently positive CSF cytology.KPS >=60

Intrathecal/intraventricular administration is a specialized setting.

Brain metastases: Patient has brain metastases from breast cancer AND trastuzumab will be used in combination with one of the listed agents (pertuzumab; capecitabine and tucatinib for patients previously treated with ≥1 regimen) AND used in an appropriate treatment setting (initial for small asymptomatic limited metastases, recurrent limited, primary for small asymptomatic extensive, or recurrent extensive with stable systemic disease).

Gastric/Esophageal Cancer

Covered for gastric, esophageal, and gastroesophageal junction adenocarcinoma when ALL of the following are met:

Advanced gastric/esophageal adenocarcinoma: Patient has adenocarcinoma that is unresectable locally advanced, recurrent, or metastatic AND trastuzumab is used as first‑line therapy in combination with chemotherapy OR in combination with pembrolizumab plus fluoropyrimidine‑ and platinum‑based chemotherapy when indicated AND tumor expresses PD‑L1 (CPS ≥1) when pembrolizumab is part of the regimen.PD‑L1 CPS >=1 when pembrolizumab used

HER2 testing per gastric cancer‑specific thresholds (IHC 3+ or ISH/FISH/NGS amplification).

Colorectal and Appendiceal Neoplasms

Covered when ALL of the following are met for colorectal/appendiceal cancers:

HER2‑targeted colorectal/appendiceal disease: Patient has RAS and BRAF wild‑type disease AND trastuzumab is used in combination with agents such as pertuzumab, lapatinib, or tucatinib per listed regimens AND used as initial or subsequent therapy in the specified settings (including unresectable metastatic disease with prior FOLFOX or CapeOX within 12 months, or subsequent therapy for progression) provided the patient has not previously received HER2‑directed therapy where specified.RAS and BRAF wild‑type

NCCN recommends universal MMR/MSI testing in newly diagnosed patients; see testing notes.

Other Tumor Types

Covered for other tumor types when indication‑specific criteria and HER2 testing requirements are met:

Endometrial carcinoma (uterine serous/carcinosarcoma): Used in combination with carboplatin and paclitaxel followed by single‑agent maintenance for uterine serous carcinoma or carcinosarcoma in patients with stage III/IV disease OR recurrent disease who have not received prior trastuzumab; not used for specified locoregional recurrence scenarios.Stage III/IV or recurrent without prior trastuzumab

Head and neck (salivary gland) tumors: Patient has a salivary gland tumor and recurrent disease with distant metastases, unresectable locoregional recurrence with prior radiation, or unresectable second primary with prior radiation; trastuzumab may be used as single agent or in combination with docetaxel or pertuzumab.

Biliary tract cancers: Used as subsequent treatment for progression after systemic therapy for unresectable or metastatic disease AND used in combination with pertuzumab or tucatinib.

HER2 testing per biliary tract criteria (IHC 3+, ISH/NGS amplification or specified combinations).

Renewal Criteria

Covered when ALL of the following are met for renewal of prior authorization:

Renewal criteria: Patient continues to meet the universal and indication‑specific criteria (including concomitant therapy requirements and performance status); duration of authorization has not been exceeded; disease response demonstrated as stabilization of disease or decrease in tumor size or spread; absence of unacceptable toxicity (examples include cardiomyopathy/left ventricular dysfunction, pulmonary toxicity, severe or febrile neutropenia, severe infusion reactions); and a recent LVEF obtained within the previous 3 months that is within institutional normal limits and has not had an absolute decrease of ≥16% from pre‑treatment baseline OR, if baseline LVEF is below institutional lower limits, has not had an absolute decrease of ≥10% from pre‑treatment baseline.LVEF change thresholds: absolute decrease <16% if baseline normal OR <10% if baseline below institutional lower limit

Prior authorizations are renewable every 6 months; neoadjuvant/adjuvant breast cancer may be renewed up to 52 weeks.

Dosage/Administration Guidance

Dose and administration guidance by indication (examples captured):

Breast cancer (neoadjuvant/adjuvant): Loading dose: 4 mg/kg IV x1 for every 7‑day schedule with maintenance 2 mg/kg IV every 7 days OR loading 8 mg/kg IV x1 for every 21‑day schedule with maintenance 6 mg/kg IV every 21 days. Use for neoadjuvant/preoperative and adjuvant treatment limited to a total of 52 weeks.52 weeks limit for neoadjuvant/adjuvant

Recurrent/metastatic and inflammatory breast cancer: Loading 4 mg/kg IV x1 every 7 days with maintenance 2 mg/kg IV every 7 days OR loading 8 mg/kg IV x1 every 21 days with maintenance 6 mg/kg IV every 21 days. Treat until disease progression or intolerable toxicity.

Gastric/Esophageal/EGJ cancers: Loading 8 mg/kg IV x1 every 21 days with maintenance 6 mg/kg IV every 21 days OR loading 6 mg/kg IV x1 every 14 days with maintenance 4 mg/kg IV every 14 days. Treat until progression or intolerable toxicity.

Supporting materials

Supporting references and appendices:

References and appendix support: Clinical trial and guideline citations (JCO, Lancet, NCCN) support the clinical indications and dosing recommendations; Appendix 1 lists covered ICD‑10 diagnosis codes; Appendix A documents NQTL considerations applied to prior authorization decisions.

See References and Appendices for full citations and covered diagnosis code list.

Therapy substitution and combination exclusions: trastuzumab must not be substituted with ado-trastuzumab emtansine (Kadcyla) or fam‑trastuzumab deruxtecan‑nxki (Enhertu). In addition, the policy prohibits use in combination with trastuzumab/hyaluronidase formulations or pertuzumab/trastuzumab hyaluronidase combinations (e.g., Herceptin Hylecta or Phesgo) as part of the covered regimens.

Billing and vial‑use rules: Herceptin (trastuzumab) is packaged only as a single‑dose vial, so the JW modifier is allowed for that product. Several biosimilars (Ogivri, Kanjinti, Trazimera, Herzuma/Trastuzumab‑pkrb, Ontruzant, Hercessi) are available as both single‑dose and multi‑dose vials; approvals for these products are based on use of the multi‑dose vial (MDV) presentation and, therefore, the JW modifier is not allowed when the MDV is used.

Medicare applicability: This policy is intended for non‑Medicare coverage determinations. National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may apply for Medicare (Part B) beneficiaries, and local Medicare policies supersede this document where applicable. Providers should consult the CMS Medicare Coverage Database for jurisdiction‑specific NCDs/LCDs/LCAs when treating Medicare members.

Renewal denial conditions summary: Prior authorization renewal will be denied when the patient no longer meets the renewal requirements — specifically if the authorization duration has been exceeded, disease is not responding (no stabilization or tumor decrease), or unacceptable drug‑related toxicity is present. Cardiac monitoring and LVEF results obtained within the prior 3 months must also meet the policy thresholds or renewal may be denied.

Examples of situations considered not medically necessary for renewal include documented disease progression despite treatment; clinically significant or unacceptable toxicity such as cardiomyopathy/left ventricular dysfunction, pulmonary toxicity, severe or febrile neutropenia, or severe infusion‑related reactions; and declines in LVEF that exceed the policy thresholds (an absolute decrease of ≥16% from baseline if baseline was normal, or an absolute decrease of ≥10% from baseline if baseline LVEF is below the institutional lower limit).

Coding, HCPCS, and Diagnosis Codes

HCPCS Unit Limits (per product and indication)HCPCS

HCPCS units

Dose-specific billable unit maxima listed per product and indication (e.g., Ogivri/Kanjinti/Trazimera/Herzuma/Trastuzumab-pkrb/Ontruzant/Hercessi: Load 92 units x1; Maintenance 138 units every 42 days for gastric; Maintenance 207 units every 21 days for CNS; Maintenance 69 units every 21 days for breast/CRC/head & neck/other indications; Herceptin (150 mg SDV): Load 90 units x1; Maintenance 150 units every 42 days for gastric; Maintenance 225 units every 21 days for CNS; 90 units every 21 days for breast/CRC/head & neck; 75 units every 21 days for other indications).

Reference product HCPCSHCPCSCovered

J9355

Injection, trastuzumab, excludes biosimilar, 10 mg (Herceptin)

Biosimilar HCPCSHCPCSCovered

Q5114	Injection, trastuzumab-dkst, biosimilar (Ogivri), 10 mg
Q5117	Injection, trastuzumab-anns, biosimilar (Kanjinti), 10 mg
Q5116	Injection, trastuzumab-qyyp, biosimilar (Trazimera), 10 mg
Q5113	Injection, trastuzumab-pkrb, biosimilar (Herzuma), 10 mg
Q5112	Injection, trastuzumab-dttb, biosimilar (Ontruzant), 10 mg
Q5146	Injection, trastuzumab-strf, biosimilar (Hercessi), 10 mg

Covered ICD-10 Diagnosis CodesICD-10Covered

C06.9	Malignant neoplasm of mouth, unspecified
C07	Malignant neoplasm of parotid gland
C08.0	Malignant neoplasm of submandibular gland
C08.1	Malignant neoplasm of sublingual gland
C08.9	Malignant neoplasm of major salivary gland, unspecified
C15.3	Malignant neoplasm of upper third of esophagus
C15.4	Malignant neoplasm of middle third of esophagus
C15.5	Malignant neoplasm of the lower third of esophagus
C15.8	Malignant neoplasm of overlapping sites of esophagus
C15.9	Malignant neoplasm of esophagus, unspecified

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inv-19: HER2 assay thresholds — exact IHC/ISH/FISH/NGS thresholds per tumor type

Breast, CNS, Uterine, Head & NeckIHC 3+; OR dual-probe ISH HER2/CEP17 ratio ≥2.0 AND average HER2 copy number ≥4.0 signals/cell; OR specific ISH+concurrent IHC combinations (e.g., ratio ≥2.0 with avg copy <4 and IHC 3+; ratio <2.0 with avg copy ≥6 and IHC 2+ or 3+; ratio <2.0 with avg copy ≥4 and <6 and IHC 3+)

Biliary tract cancersIHC 3+; OR dual-probe ISH HER2/CEP17 ratio ≥2.0 AND average HER2 copy number ≥4.0 signals/cell; OR ISH with concurrent IHC combinations as specified; OR NGS panel showing HER2 amplification

Gastric/Esophageal/EGJ cancersIHC 3+; OR FISH/ISH with concurrent IHC meeting one of: HER2/CEP17 ratio ≥2.0 AND concurrent IHC 2+; OR average HER2 copy number ≥6.0 signals/cell AND concurrent IHC 2+; OR NGS panel showing HER2 amplification

Colorectal & Appendiceal cancersIHC 3+; OR FISH/ISH HER2/CEP17 ratio ≥2.0 AND concurrent IHC 2+; OR NGS panel showing HER2 amplification

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization validity

Initial prior authorizations are valid for 6 months. Renewals may be requested every 6 months thereafter unless a different duration is specified. For neoadjuvant/preoperative and adjuvant breast cancer treatment, prior authorization may be renewed up to a maximum of 52 weeks of treatment.

Initial prior authorization validity: 6 months
Renewal cadence: every 6 months unless specified otherwise
Neoadjuvant/adjuvant breast cancer: renewals allowed up to 52 weeks total

Prior Authorization

Prior authorization renewal requirements

Renewal of prior authorization requires documentation that the member continues to meet the universal and any indication-specific criteria, that the authorized duration has not been exceeded, and that the clinical benefit and safety profile remain acceptable.

Member continues to meet universal and relevant indication-specific criteria (see section III)
Duration of authorization has not been exceeded (see Section I)

Initial Therapy Criteria and Dosing

Initial Therapy Criteria

Initial therapy criteria by indication

General initial requirements: Patient is ≥18 years; documented contraindication, intolerance, or failure to Kanjinti, Ogivri, AND Ontruzant prior to consideration of another trastuzumab product; baseline LVEF within institutional normal limits with plan for interval monitoring; HER2‑positive disease confirmed by an FDA‑approved or CLIA‑compliant test; appropriate pregnancy testing and contraception as specified.age >=18

Initial authorizations provided for 6 months.

Indication‑specific initial requirements: Refer to indication‑specific criteria groups (Breast Cancer; CNS Cancers; Gastric/Esophageal Cancer; Colorectal and Appendiceal Neoplasms; Other Tumor Types) for detailed initial coverage conditions.

Initial Therapy Dosing

Initial dosing guidance by indication

Continuation and Renewal Criteria

Continuation/Renewal Therapy

Renewal criteria and authorization duration

Renewal requirements and duration: Prior authorization may be renewed every 6 months provided the patient continues to meet universal and indication‑specific criteria; duration of authorization has not been exceeded (see Section I for limits, including neoadjuvant/adjuvant breast cancer up to 52 weeks); disease response documented as stabilization or tumor decrease; absence of unacceptable toxicity; and required LVEF monitoring within the prior 3 months meeting specified change thresholds.Renewal interval = every 6 months; neoadjuvant/adjuvant up to 52 weeks

Initial authorization provided for 6 months.

Continuation/Renewal

Continuation (renewal) requires ongoing response and acceptable toxicity profile.

Continuation requirements: Patient continues to meet universal and indication‑specific criteria; authorization duration not exceeded; documented disease response (stabilization or tumor decrease); absence of unacceptable toxicity; and LVEF within institutional normal limits without exceeding absolute decrease thresholds, with LVEF obtained within the previous 3 months.

Step Therapy Requirements

Step	Requirement
1	Must have documented contraindication, intolerance, or treatment failure to Kanjinti (trastuzumab-anns), Ogivri (trastuzumab-dkst), AND Ontruzant (trastuzumab-dttb) prior to consideration of another trastuzumab product.

Step	Continuation / Renewal Requirement
1	Continuation/renewal requires the patient continue to meet universal and indication‑specific criteria, duration of authorization not exceeded, evidence of disease response (stabilization or tumor decrease), absence of unacceptable toxicity, and LVEF obtained within the previous 3 months meeting specified change thresholds.

Step therapy presence	Note / PA considerations
No explicit steps provided	Document does not include additional stepwise sequences beyond the prerequisite biosimilar trial; Appendix A (NQTL checklist) notes prior authorization may be considered based on indication, safety/efficacy, and drug cost.

Quantity Limits and Unit Conversions

inv-46: Herceptin (150 mg SDV) — loading and maintenance unit guidance by indication

Loading dose (Herceptin 150 mg SDV) — all indicationsLoad: 90 billable units x 1 dose (1 BU = 10 mg, per J9355)

Maintenance — Gastric/Esophageal/EGJMaintenance: 150 billable units every 42 days

Maintenance — CNS (intrathecal/intraventricular context referenced separately)Maintenance: 225 billable units every 21 days

Maintenance — Breast/Colorectal/Head & NeckMaintenance: 90 billable units every 21 days

Maintenance — All other indicationsLoad: 90 units x1; Maintenance: 75 billable units every 21 days

inv-47: Ogivri, Kanjinti, Trazimera, Herzuma/Trastuzumab-pkrb, Ontruzant, Hercessi (420 mg MDV) — loading and maintenance unit guidance by indication

Site of Care and Administration Settings

Note

Site of care and intrathecal use for leptomeningeal disease

Site-of-care depends on indication: intravenous administration is per usual infusion settings (infusion center, hospital outpatient, office, or home as applicable). For leptomeningeal metastases from breast cancer, intrathecal or intraventricular administration is permitted.

IV administration for non‑CNS indications in infusion center, hospital outpatient, office, or home (as applicable).
Intrathecal/intraventricular administration permitted for leptomeningeal metastases.

Note

Specialized intrathecal/intraventricular setting for leptomeningeal metastases

Intrathecal or intraventricular trastuzumab administration for leptomeningeal disease is identified as a specialized setting and is allowable when the patient meets leptomeningeal metastases criteria.

Biosimilar Use and Billing Guidance

Billing Rule

Biosimilar prerequisite trial summary

The policy requires trial or documented intolerance/contraindication to the listed biosimilars (Kanjinti, Ogivri, Ontruzant) before consideration of other trastuzumab products.

Billing Rule

Herceptin HCPCS and MDV/JW modifier guidance

Herceptin is reported with HCPCS J9355; note that Ogivri, Kanjinti and some biosimilars are available as MDV/SDV configurations and approvals for MDV products are based on MDV availability—JW modifier guidance differs by vial type.

Herceptin HCPCS = J9355.
MDV vs SDV availability noted for biosimilars; JW modifier allowed for Herceptin SDV.

Billing Rule

Herceptin/biosimilar HCPCS vial configuration note (Q5117)

HCPCS entries note Q5117 (Kanjinti) with available vial configurations; the policy lists vial size and MDV/SDV information for billing and availability.

Background

Background — trastuzumab clinical summary: Trastuzumab is a HER2‑directed monoclonal antibody used to treat multiple HER2‑expressing malignancies, including breast cancer (adjuvant, neoadjuvant, metastatic, and inflammatory settings), gastric/gastroesophageal adenocarcinoma, colorectal and appendiceal HER2‑amplified tumors, biliary tract and selected head and neck salivary gland tumors, uterine serous carcinoma/carcinosarcoma, and CNS leptomeningeal or brain metastases from breast cancer. Because trastuzumab carries a risk of cardiotoxicity, baseline and regular LVEF assessment (e.g., every ~3 months) is required, and HER2 positivity must be documented by an FDA‑approved or CLIA‑compliant assay prior to therapy.

Definitions and Guideline References

inv-35: HER2-positive — defined per indication using IHC/ISH/FISH/NGS criteria

Definition — HER2-positive by IHCIHC assay 3+ qualifies as HER2-positive for multiple tumor types

Definition — HER2-positive by ISH/FISHDual-probe ISH/FISH criteria: HER2/CEP17 ratio ≥2.0 (with additional average copy number requirements per tumor type) qualify as HER2-positive

Definition — HER2-positive by IHC+ISH combinationsSpecified ISH ratio/copy number with concurrent IHC (examples: ratio ≥2.0 with avg copy <4 and IHC 3+; ratio <2.0 with avg copy ≥6 and IHC 2+ or 3+; ratio <2.0 with avg copy ≥4 and <6 and IHC 3+)

Definition — HER2-positive by NGSNext-generation sequencing (NGS) panel demonstrating HER2 amplification is accepted for tumor types where listed (e.g., biliary, gastric, colorectal)

inv-36: Leptomeningeal metastases — definition and note on intrathecal/intraventricular use

Revision History

2025-12-02policy_reviewLatest

Policy last reviewed on 2025-12-02 per document metadata; no material clinical policy statement changes noted in brief but review date is recorded.

2025-07reference_update

NCCN guideline references for intrathecal trastuzumab and other templates were accessed/updated in July 2025 as cited in references (NCCN access July 2025).

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Trastuzumab (Herceptin and biosimilars) — Coverage Criteria

Coverage Criteria for Trastuzumab and Biosimilars

Coding, HCPCS, and Diagnosis Codes

Provider Actions, Prior Authorization, and Documentation

Initial Therapy Criteria and Dosing

Continuation and Renewal Criteria

Step Therapy Requirements

Quantity Limits and Unit Conversions

Site of Care and Administration Settings

Biosimilar Use and Billing Guidance

Background

Definitions and Guideline References

Revision History