Trastuzumab (Herceptin and biosimilars) Coverage Criteria
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Medical policy governing coverage, prior authorization, step therapy, and clinical criteria for trastuzumab and its biosimilars for AlohaCare Medicaid & Medicare members.
Added Continuity of Care requirement.
Coverage Criteria for Trastuzumab and Biosimilars
inv-01: Continuation Criteria
Covered when ALL of the following are met for continuation:
inv-02: Initial Therapy Criteria by Indication
Covered when ALL of the following are met for the specific indication:
inv-03: Program-specific Product Requirements
Program-specific restrictions that must be met in addition to clinical criteria:
Concurrent use exclusion: Coverage is excluded when trastuzumab is used concurrently with another trastuzumab or trastuzumab-based product (for example, Kadcyla, Enhertu, Herceptin Hylecta, or Phesgo). This exclusion applies regardless of indication and should be confirmed on the request to avoid approval delays or denial.
Use of trastuzumab outside the specific indications listed in this policy is not supported unless the diagnosis is documented in an accepted compendium or peer-reviewed literature and all program requirements are met. For non‑labeled or less common indications, ensure the request includes compendia citations (e.g., NCCN, DRUGDex, AHFS‑DI) or peer‑reviewed evidence and baseline cardiac assessment. Baseline LVEF must be within normal limits prior to initiating therapy and documentation of the prescriber specialty (oncologist or consultation with an oncologist) is required for approval. Additionally, program-specific product rules (Medicaid and Medicare step therapy/substitution requirements) must be satisfied as applicable for the member’s program.
Initial Therapy — Indication-specific Requirements
inv-15: Initial Therapy Criteria
Initial approval requires documented diagnosis and indication-specific regimen plus baseline LVEF and prescriber specialty:
Continuation Therapy Requirements
inv-16: Continuation Therapy
Continuation approval requires meeting general continuation criteria:
Coding and Codes
| J9355 | Injection, trastuzumab, excludes biosimilar, 10 mg |
| 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, Authorization & Documentation
Authorization required (Medical Benefit)
Medical benefit — authorization required. Requests for trastuzumab (Herceptin) and listed biosimilars must meet the clinical coverage criteria and required documentation (including LVEF assessment) to be approved under the Medical Benefit.
Medicare Part B step‑therapy requirement
For Medicare Part B new starts, prescribers must document prior trial and inadequate response to, intolerance of, or contraindication to Herzuma (trastuzumab‑pkrb) or Trazimera (trastuzumab‑qyyp) before Herceptin, Kanjinti, Ogivri, or Ontruzant will be approved.
- Applies to new starts under Medicare Part B
- Acceptable reasons: inadequate response, intolerable adverse event, or contraindication to Herzuma or Trazimera
Cardiac monitoring and progression documentation
Obtain and document a left ventricular ejection fraction (LVEF) assessment performed within the last 3 months; continuation approval requires no disease progression and LVEF changes within allowed limits.
- If LVEF is within normal limits: absolute decrease from baseline must be ≤16%
- If LVEF is below normal limits: absolute decrease from baseline must be ≤10%
- Documentation must show member does not have evidence of disease progression while on therapy
ADRC referral with chart notes required for QUEST & non‑ABD members
For QUEST and non‑ABD members with cancer, pharmacy staff must send an ADRC referral with chart notes for both initial and continuation authorization requests.
- Include relevant oncology chart notes with the ADRC referral
- Requirement applies to initial and continuation requests
Exclusion — concurrent trastuzumab products
Concurrent use of trastuzumab with another trastuzumab or trastuzumab‑based product is excluded and will lead to denial if documented.
- Examples: Kadcyla, Enhertu, Herceptin Hylecta, Phesgo
Step Therapy Requirements
| Step | Applies to | Requirement before approval |
|---|---|---|
| 1 | Medicare Part B — new starts | Member must have an inadequate response to, intolerable adverse event to, or a contraindication to Herzuma (trastuzumab-pkrb) or Trazimera (trastuzumab-qyyp) before Herceptin, Kanjinti, Ogivri, or Ontruzant will be approved |
Site of Care and Benefit Type
Infusion center — medical benefit (pharmacy benefit excluded)
Infusion administration is processed under the Medical Benefit; the pharmacy benefit is excluded. Submit authorization and billing under the Medical Benefit/infusion center.
- Duration of approval: initial request 6 months; reauthorization/continuity of care 12 months
- Formulary and site‑of‑care handled via infusion center (medical benefit)
Biosimilar Preferences and Notes
Medicare preferred biosimilars for Herceptin
For Medicare members, the policy identifies Herzuma and Trazimera as the preferred trastuzumab biosimilars for Herceptin under Medicare.
- Medicare preferred products: Herzuma, Trazimera
QUEST preferred biosimilars for Herceptin
For QUEST members, the policy identifies Kanjinti and Trazimera as the preferred trastuzumab biosimilars for Herceptin.
- QUEST preferred products: Kanjinti, Trazimera
Products and Definitions
Background
Trastuzumab is an anti‑HER2 monoclonal antibody used to treat HER2‑overexpressing malignancies, including adjuvant and metastatic breast cancer and metastatic gastric/gastroesophageal junction adenocarcinoma. Because of potential cardiotoxicity, the policy requires baseline and ongoing assessment of left ventricular ejection fraction (LVEF) when initiating and continuing therapy. Multiple biosimilars of trastuzumab are available and program‑specific preferences or step therapy requirements may apply.
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