Does J9355 require prior authorization?

Yes, J9355 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J9355?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J9355`, Injection, trastuzumab, excludes biosimilar, 10 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

Precertification / Statement of Medical Necessity (SMN) forms required for precertification (contact: call (866) 752-7021 or fax (888) 267-3277; see Specialty Pharmacy Precertification forms).
Documentation of tumor HER2 status using an FDA-approved companion diagnostic (e.g., IHC and/or FISH) performed by laboratories with demonstrated proficiency. The policy specifies using FDA-approved tests for HER2 assessment.
For colorectal cancer indication: documentation that tumor is HER2-amplified and RAS and BRAF wild-type, and documentation that therapy will be given in combination with pertuzumab or lapatinib and that patient meets one of the specified scenarios (not appropriate for intensive therapy OR subsequent therapy for progression).
Evidence of prior therapies and clinical context where relevant (e.g., prior systemic therapy, progression status, suitability for intensive therapy) to support the chosen indication.
For continuation/reauthorization: documentation that there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Cardiac monitoring documentation: a baseline cardiac function test measuring left ventricular ejection fraction (LVEF/Ejection Fraction) prior to initiating trastuzumab (or anthracycline) therapy; further cardiac function monitoring is recommended at approximately 3, 6, and 9 months during trastuzumab therapy. Discontinuation should be considered with clinically significant decreases in left ventricular function.

Key Coverage Criteria

Coverage of injectable oncology medications is based on NCCN Compendium Categories of Evidence and Consensus (1, 2A, 2B = proven/medically necessary; 3 = unproven/not medically necessary); if NCCN is unavailable, base decisions on FDA labeling.
C18.0 - C18.9 Malignant neoplasm of colon [unresectable, advanced, or metastatic]
C20 Malignant neoplasm of rectum
Subcutaneous formulation (trastuzumab and hyaluronidase-oysk; Herceptin Hylecta) as an approved formulation of trastuzumab for the same HER2-positive breast cancer indications (inferred from prescribing information and FDA approval notice).
Neoadjuvant treatment of HER2-positive breast cancer as part of a complete treatment regimen (trastuzumab or biosimilars).
Adjuvant treatment of HER2-positive breast cancer (trastuzumab or biosimilars).

20 Active Policies

ARKBLUE-TRASTUZUMAB-E-G-HERCEPTIN-AND-BIOSIMILARS-AND-TR-FB46EDB7E0, Trastuzumab (e.g., Herceptin) and Biosimilars and Trastuzumab/Hyaluronidase-oysk (e.g., Herceptin Hylecta)

HEALTHPARTNERS-CC-ENTRY-227137, Oncology - ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), trastuzumab (Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera), and trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) – Minnesota Health Care Programs

MULTI

HEALTHPARTNERS-CC-ENTRY-237405, Oncology - trastuzumab (Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera), and trastuzumab and hyaluronidase-oysk (Herceptin Hylecta)

MULTI

BCBSND-TRASTUZUMAB-HERCEPTIN-TRASTUZUMAB-BIOSIM-F11E6177D8, Trastuzumab Herceptin Trastuzumab Biosimilars AND Trastuzumab AND Hyaluronidase Oysk Herceptin Hylecta

BCBSNJ-DRUGS-011-749DD9CCDF, Trastuzumab (Herceptin), Trastuzumab-dkst (Ogivri), Ado-trastuzumab emtansine (Kadcyla), Trastuzumab-pkrb (Herzuma), Trastuzumab-dttb (Ontruzant), Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta), Trastuzumab-qyyp (Trazimera), Trastuzumab-anns (Kanjinti), Fam-trastuzumab deruxtecan-nxki (Enhertu), Pertuzumab (Perjeta), and Pertuzumab, Trastuzumab, and hyaluronidase-zzxf (Phesgo)

MODA-TRASTUZUMAB-IV-0202C8C90A, Trastuzumab: Herceptin; Ogivri; Kanjinti; Trazimera; Herzuma; Ontruzant

HEALTHNET_OR-HNOR-TRASTUZUMAB-HERCEPTIN-AND-BIOSIMILARS-CP-PHAR-228-830D493BF0, Trastuzumab (Herceptin) and biosimilars; CP.PHAR.228

IBX-COMMERCIAL-08-00-33W-2CAD8EDA70, Trastuzumab (Herceptin) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta)

IBX-MEDICARE-ADVANTAGE-MA08-018M-78B08205FE, Trastuzumab (Herceptin) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta)

BCBSNM-RX502.061, Oncology Medications

BCBSOK-RX502.061, Oncology Medications

UMR-POL-UMR-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage

EVICORE-HPLAN-CIGNA-729A536F50C8, Q3 - 2026 Cigna MedOnc Master Drug List.pdf

SUREST-POL-SUREST-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage

EVICORE-HPLAN-HEALTH_PARTNERS_PLANS-4BC80209CCC5, Q3 - 2026 Jefferson Health Plans MedOnc Master Drug List

AMERIHEALTH-COMMERCIAL-08-00-33W-42AE99A062, Trastuzumab (Herceptin) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta)

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-018M-161A31B5CF, Trastuzumab (Herceptin) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta)

BCBSTN-b852c9f8ce, Trastuzumab Products (Herceptin, Ontruzant, Herzuma, Ogivri, Trazimera, Kanjinti, Hercessi)

UHC-POL-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage

AETNA-CPB-0313, Trastuzumab Products

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J9355, Injection, trastuzumab, excludes biosimilar, 10 mg