Herceptin/Biosimilars, Trastuzumab-Hyaluronidase (coverage criteria)
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Defines medical necessity and prior authorization criteria for trastuzumab, its biosimilars, and trastuzumab-hyaluronidase (Herceptin Hylecta) for Arizona Complete Health Medicaid lines of business (AzCH-CCP and Care1st). Applies to providers prescribing these agents for oncology indications.
Policy updated to make biosimilars preferred and Herceptin non-preferred, with no grandfathering.
Added qualifiers of 'advanced' and 'recurrent' for gastric, esophageal, or EGJ adenocarcinoma and added additional supported off-label indications per NCCN.
Specified dose rounding vial recommendations for trastuzumab dosing ranges.
Herceptin will be non-preferred and listed biosimilars will be preferred (effective 9/1).
Added gallbladder cancer and cholangiocarcinoma as NCCN-supported off-label indications.
Coverage Criteria
Initial Therapy — Breast Cancer
Initial Approval — Breast Cancer (must meet ALL):
Prescribed regimen must be FDA-approved or recommended by NCCN
Initial Therapy — Gastric/Esophageal/EGJ Cancer
Initial Approval — Gastric, Esophageal, and EGJ Cancer (must meet ALL):
Prescribed regimen must be FDA-approved or recommended by NCCN
Initial Therapy — Endometrial Carcinoma (off-label)
Initial Approval — Endometrial Carcinoma (off-label, must meet ALL):
Off-label — prescriber must submit supporting evidence
Initial Therapy — Colorectal Cancer (off-label)
Initial Approval — Colorectal Cancer (off-label, must meet ALL):
Off-label — prescriber must submit supporting evidence
Initial Therapy — Salivary Gland Tumor (off-label)
Initial Approval — Salivary Gland Tumor (off-label, must meet ALL):
Off-label — prescriber must submit supporting evidence
Initial Therapy — Gallbladder/Cholangiocarcinoma (off-label)
Initial Approval — Gallbladder Cancer or Cholangiocarcinoma (off-label, must meet ALL):
Off-label — prescriber must submit supporting evidence
Initial Therapy — Other Indications
Initial Approval — Other diagnoses/indications (must meet ALL):
Off-label requests require reference to off-label policy
Continued Therapy
Continued Approval (All indications in Section I — must meet ALL):
Prescribed regimen must be FDA-approved or recommended by NCCN; approval duration for continued therapy: 12 months (or duration of request/6 months depending on section)
Indication-specific dosing/coverage
Covered when dosing and indication align with FDA- or NCCN-supported regimens
Chunk support: 24,26
Chunk support: 26,27
Chunk support: 28
Preference and supported indications (partial)
Summary from available text
Effective 9/1 policy update
2Q 2023 annual review
Non‑FDA approved indications that are not specifically addressed within this policy are not authorized for coverage unless the prescriber provides sufficient documentation of efficacy and safety consistent with the off‑label use policy AZ.CP.PMN.53 or the member's evidence of coverage documents.
Requests for treatment of diagnoses or indications that are not FDA‑approved and are not listed in this policy must be supported by clinical evidence in accordance with the off‑label use policy AZ.CP.PMN.53. Providers must submit supporting literature or guideline documentation with the prior authorization request when relying on off‑label use.
Grandfathering does not apply to this policy. Effective 9/1 the listed trastuzumab biosimilars are designated as preferred and Herceptin (trastuzumab) will be non‑preferred; members may not retain prior Herceptin coverage under grandfathering provisions.
Use of trastuzumab for indications not listed in this policy and lacking sufficient off‑label evidence per AZ.CP.PMN.53 may be considered not medically necessary and may be denied.
Contraindications: none reported in the policy appendices. Boxed warnings applicable to trastuzumab and listed biosimilars include cardiomyopathy, infusion reactions, embryo‑fetal toxicity, and pulmonary toxicity. The subcutaneous formulation (Herceptin Hylecta) carries boxed warnings for cardiomyopathy, embryo‑fetal toxicity, and pulmonary toxicity.
Coding and Dosing Reference
| AZ.CP.PHAR.228 | Policy reference number (internal policy identifier) |
| J9355 | Injection, trastuzumab, 10 mg |
| J9356 | Injection, trastuzumab, 10 mg and hyaluronidase-oysk |
| Q5112 | Injection, trastuzumab-dttb, biosimilar, (Ontruzant), 10 mg |
| Q5113 | Injection, trastuzumab-pkrb, biosimilar, (Herzuma), 10 mg |
| Q5114 | Injection, trastuzumab-dkst, biosimilar, (Ogivri), 10 mg |
| Q5116 | Injection, trastuzumab-qyyp, biosimilar, (Trazimera), 10 mg |
| Q5117 | Injection, trastuzumab-anns, biosimilar, (Kanjinti), 10 mg |
Provider Actions and Authorization
Prior Authorization Required
Prior authorization is required for initial and continued use of Herceptin and biosimilars for all indications in this policy. Providers must obtain PA before dispensing/administering the requested agent; approval durations are typically 6 months for initial requests and up to 12 months for continuation requests as specified under Initial and Continued Approval criteria. The policy assists coverage decisions; coverage remains subject to the member's evidence of coverage and other plan terms.
- Prior authorization required for initial and continuation requests
- Typical approval duration: 6 months for initial therapy; continuation approvals may be up to 12 months (see policy sections I and II)
Documentation Required for Prior Authorization and Off‑Label Use
Providers must submit supporting clinical documentation with the PA request (office chart notes, lab results, pathology, diagnostic testing, treatment history, and any peer‑reviewed evidence when requesting off‑label use). Failure to provide adequate documentation may result in denial. For non‑FDA (off‑label) indications, coverage requires documentation consistent with the Health Plan's off‑label policy (AZ.CP.PMN.53 for Arizona Medicaid) or other evidence of efficacy and safety.
- Examples of required documentation: office notes, labs, pathology, diagnostic test results, and treatment history
- Off‑label requests must include supporting practice‑guideline or peer‑reviewed literature; reference AZ.CP.PMN.53 for Arizona Medicaid
Biosimilar Preference and Step‑Therapy Note
This policy does not impose explicit step‑therapy (step) rules beyond the biosimilar‑first preference for trastuzumab products. When requesting the originator product (Herceptin) or a specific branded product (e.g., Herceptin Hylecta or Ontruzant), providers must document why biosimilars (listed in the policy) cannot be used—such as contraindications or clinically significant adverse effects. Grandfathering does not apply to Herceptin; requests for non‑preferred originator product may be denied if biosimilar alternatives are appropriate.
- No separate step‑therapy algorithm is specified in this policy
- Biosimilars are designated preferred effective 9/1; Herceptin is non‑preferred and grandfathering does not apply
- If requesting Herceptin/Ontruzant, member must have trialed ALL listed biosimilars unless contraindicated or not tolerated
Clinical Judgment and Coverage Conditions
Providers are expected to exercise professional medical judgment. Coverage decisions require that the prescribed regimen be FDA‑approved or recommended by NCCN; for supported off‑label uses, the prescriber must submit evidence. Coverage is subject to all plan terms, conditions, exclusions, and limitations.
- Prescribed regimen must be FDA‑approved or recommended by NCCN when applicable
- For NCCN‑supported off‑label indications, submit supporting evidence with the PA request
- Coverage decisions are subject to member benefit documents and plan exclusions
Background
Trastuzumab is a monoclonal antibody that targets the HER2 (human epidermal growth factor receptor 2) receptor and is indicated for HER2‑overexpressing malignancies. The policy covers IV trastuzumab and multiple approved biosimilars as well as the subcutaneous combination formulation trastuzumab‑hyaluronidase (Herceptin Hylecta). Indications include adjuvant and metastatic HER2‑positive breast cancer and metastatic HER2‑positive gastric/EGJ adenocarcinoma per FDA labeling; select NCCN‑supported off‑label indications (for example, gallbladder cancer and cholangiocarcinoma) are also recognized when supported by appropriate documentation. Note that biosimilars are preferred under the formulary and prior authorization requirements apply.
Definitions
Initial Therapy Criteria
Initial therapy — diagnosis-specific initial therapy requirements
Initial therapy requirements vary by diagnosis; must meet indication-specific criteria including oncologist involvement, age ≥ 18, combination regimens where specified, biosimilar-first usage when requesting Herceptin/Ontruzant, prior authorization, and dose limits or literature support for off-label use.
Prescribed regimen must be FDA-approved or recommended by NCCN; off-label uses require supporting evidence.
Initial therapy dosing — dosing depends on indication and product
Initial dosing depends on indication and product
Chunks 24,26
Chunk 26
Continuation / Maintenance Criteria
Continued Therapy
Continued therapy requirements
Continuation therapy dosing — maintenance/continuation dosing rules per indication
Maintenance/continuation dosing rules per indication
chunk 24
chunks 26,27
Step Therapy / Product Selection
| Requirement | Details / When Applies |
|---|---|
| Biosimilar-first requirement when requesting Herceptin or Ontruzant | |
| If the request is for Herceptin (originator) or Ontruzant, the member must have used ALL listed biosimilars (Herzuma, Kanjinti, Ogivri, Trazimera) unless clinically significant adverse effects occurred or all are contraindicated; applies to initial and continued therapy and must be documented in the prior authorization request. |
| Coverage label | Policy detail |
|---|---|
| Herceptin | |
| Effective 9/1 the listed trastuzumab biosimilars are preferred and Herceptin is non-preferred; formulary preference may result in Herceptin being processed as non-preferred or denied if biosimilars are available and clinically appropriate. Grandfathering does not apply. |
| Step therapy / preference | Implication / Notes |
|---|---|
| No explicit sequential step-therapy defined | |
| Although no stepwise sequence is specified, the payer’s product-selection preference for biosimilars functions operationally as a formulary step: biosimilars should be used when available and appropriate, and requests for non-preferred products (Herceptin) are subject to non‑preferred processing and lack of grandfathering. |
Quantity Limits and Vialing
Site of Care
Administration settings — infusion center, office, outpatient, home; Hylecta SC notes
IV trastuzumab formulations are administered in infusion settings (infusion center, office, hospital outpatient) and may be administered at home where permitted; Herceptin Hylecta is a subcutaneous product given per dosing guidance.
- Hylecta (Herceptin Hylecta): 600 mg trastuzumab + 10,000 units hyaluronidase SC q3weeks; administer over ~2–5 minutes.
- IV dosing regimens and site‑of‑care should follow provider and payer site‑of‑care rules.
Biosimilar Policy Notes
Herceptin — preferred use of biosimilars prior to originator/Ontruzant
When applicable, preferred biosimilars (AHCCCS preferred) should be used prior to Herceptin or Ontruzant; the policy directs use of biosimilars first unless contraindicated.
- AHCCCS preferred biosimilars include Herzuma, Kanjinti, Ogivri, and Trazimera.
Herceptin — preferred product use reminder
Reminder: the policy designates preferred biosimilars and non‑preferred Herceptin status; follow the biosimilar‑first requirement when submitting PA requests.
- Requests for Herceptin without biosimilar use must document clinical justification for an exception.
Herceptin — preferred product use reminder (effective 9/1)
Herceptin is non‑preferred effective 9/1 when listed biosimilars are preferred; there is no grandfathering—members cannot automatically retain Herceptin coverage based on prior use.
- Plan implemented the formulary preference change effective 9/1 per policy update.
Herceptin — effective 9/1 biosimilars preferred; no grandfathering
Effective 9/1 the policy update designates biosimilars preferred and Herceptin non‑preferred; grandfathering does not apply to retain Herceptin coverage.
- Providers should anticipate formulary edits and prior authorization denials for Herceptin when biosimilars are available and appropriate.
Herceptin — biosimilars preferred; no grandfathering
Biosimilars listed in the policy are preferred and Herceptin is non‑preferred; the policy explicitly states that grandfathering does not apply.
- AHCCCS preferred: Herzuma, Kanjinti, Ogivri, Trazimera; AHCCCS non‑preferred: Herceptin, Ontruzant, Hylecta.
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