Overview

This document addresses the use of Herceptin Hylecta (trastuzumab; hyaluronidase) and Herceptin (trastuzumab) biosimilar products which include Ogivri, Herzuma, Ontruzant, Trazimera, and Kanjinti. Herceptin is a monoclonal antibody for HER2/neu receptors for use in HER2-overexpressing adjuvant and metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. The following table list the agents included in the class according to their FDA approval dates:

Name
Biosimilar name
Dosage vial
FDA Approval Date
FDA Indications
Treatment of HER2-overexpressing metastatic breast cancer
X
Adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer X

Herceptin (Genentech)
trastuzumab

Ogivri (Mylan/GMBH)
trastuzumab-dkst
Herzuma (Teva/Celltrion)
trastuzumab-pkrb
Ontruzant (Samsung Bioepsis/Merck)
trastuzumab-dttb
Herceptin Hylecta (Genentech)
trastuzumab; hyaluronidase-oysk
Trazimera (Pfizer)
trastuzumab-qyyp

• 9/25/1998
• 12/01/2017 X
• 12/14/2018 X
• 1/18/ 2019
• 2/28/2019
• 3/11/2019 X X X

150 mg/vial (IV only) 150 mg/vial 420 mg/vial (IV only) 150 mg/vial 420 mg/vial (IV only) 150 mg/vial 420 mg/vial (IV only) 120 mg/2,000 units/mL (SC only) 150 mg/vial 420 mg vial (IV only)

• X
• X
• X
• X
• X

HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma X X X X X

1. Kanjinti (Amgen)
   trastuzumab-anns
   150 mg vial
   420 mg vial (IV only)
   6/13/2019 X X X

Herceptin Hylecta, Herceptin, and its biosimilars carry a boxed warning regarding possible risks for cardiomyopathy, infusion reactions, pulmonary toxicity, and embryo-fetal toxicity. Trastuzumab use can result in cardiac failure that manifests as congestive heart failure (CHF) or decreased left ventricular ejection fraction (LVEF) with greatest risk when administered concurrently with anthracyclines.

Definitions and Measures

• Adjuvant or adjunctive treatment: Treatment given after the primary treatment to increase the chances of a cure and may include chemotherapy, radiation, hormone or biological therapy.
• Metastasis: The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.
• Monoclonal antibody: A protein developed in the laboratory that can locate and bind to specific substances in the body and on the surface of cancer cells.
• Targeted biologic agent: A newer type of drug developed specifically to target genetic changes in cells that cause cancer. It works differently than standard chemotherapy drugs, often with different side effects.

Clinical Criteria

When a drug is being reviewed for coverage under a member's medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

• Herceptin (trastuzumab); Ogivri (trastuzumab-dkst); Herzuma (trastuzumab- pkrb); Ontruzant (trastuzumab-dttb); Trazimera (trastuzumab-qyyp); Kanjinti (trastuzumab-anns)

Requests for Herceptin (trastuzumab) Ogivri (trastuzumab-dkst) Herzuma (trastuzumab- pkrb) Ontruzant (trastuzumab-dttb) Trazimera (trastuzumab-qyyp) or Kanjinti (trastuzumab-anns) may be approved.

• Herceptin Hylecta (trastuzumab; hyaluronidase-oysk)

Requests for Herceptin Hylecta (trastuzumab; hyaluronidase-oysk) may be approved.

Step Therapy

Trastuzumab Reference and Biosimilar Agents Step Therapy

A list of the preferred trastuzumab agents is available here. Requests for a non-preferred trastuzumab agent may be approved when the following criteria is met:

1. Individual has had a trial and intolerance to one preferred trastuzumab agent; OR
2. Individual is currently stabilized on the requested non-preferred trastuzumab agent.

Preferred, as used herein, refers to agents that were deemed to be clinically comparable to other agents in the same class or disease category but are preferred based upon clinical evidence and cost effectiveness.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• J9356 Injection, trastuzumab, 10 mg and hyaluronidase-oysk (Herceptin Hylecta)
• J9355 Injection, trastuzumab, excludes biosimilar, 10 mg
• Q5113 Injection, trastuzumab-pkrb, biosimilar, (Herzuma), 10 mg
• Q5117 Injection, trastuzumab-anns, biosimilar, (Kanjinti), 10 mg
• Q5114 Injection, Trastuzumab-dkst, biosimilar, (Ogivri), 10 mg
• Q5112 Injection, trastuzumab-dttb, biosimilar, (Ontruzant), 10 mg
• Q5116 Injection, trastuzumab-qyyp, biosimilar, (Trazimera), 10 mg

ICD-10-CM

All Diagnoses

Document History

Revised: 05/19/2023