WHA

Trastuzumab - PA, NF

Indications for Prior Authorization

Herceptin (trastuzumab), Hercessi (trastuzumab-strf), Herzuma (trastuzumab-pkrb), Kanjinti (trastuzumab-anns), Ogivri (trastuzumab-dkst), Ontruzant (trastuzumab-dkst), Trazimera (trastuzumab-qyyp)
  • For diagnosis of Adjuvant Breast Cancer
    Indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer: 1) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, 2) with docetaxel and carboplatin, 3) as a single agent following multi-modality anthracycline based therapy.

  • For diagnosis of Metastatic Breast Cancer
    Indicated: 1) In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, 2) As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

  • For diagnosis of Metastatic Gastric Cancer
    Indicated in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)
  • For diagnosis of Adjuvant Breast Cancer
    Indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer: 1) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, 2) as part of a treatment regimen with docetaxel and carboplatin, 3) as a single agent following multi-modality anthracycline based therapy.

  • For diagnosis of Metastatic Breast Cancer
    Indicated in adults: 1) In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, 2) As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

Criteria

Kanjinti, Trazimera

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Adjuvant or Neoadjuvant Breast Cancer

  • Diagnosis of HER2-overexpressing of breast cancer [A]
    • AND
  • One of the following treatment regimens: [4, C]
    • Adjuvant treatment
    • Used in combination with Perjeta (pertuzumab)
Kanjinti, Trazimera

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Breast Cancer

  • Diagnosis of HER2-overexpressing of breast cancer [A]
    • AND
  • Disease is metastatic
    • AND
  • One of the following treatment regimens: [3-5, 7, C]
    • Used in combination with a taxane
    • Used as a single agent in a patient who has received one or more chemotherapy regimens for metastatic disease
    • Used in combination with Perjeta (pertuzumab)
Kanjinti, Trazimera

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Breast Cancer

  • Patient does not show evidence of progressive disease while on therapy
Kanjinti, Trazimera

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Gastric Cancer

  • Diagnosis of HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma (locally advanced, recurrent, or metastatic) [3-5, 7, A-C]
    • AND
  • Used in combination with one of the following treatment regimens: [3-5, 7, C]
    • Platinol (cisplatin) and Adrucil (5-fluorouracil)
    • Platinol (cisplatin) and Xeloda (capecitabine)
Kanjinti, Trazimera

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Gastric Cancer

  • Patient does not show evidence of progressive disease while on therapy
Herceptin Hylecta

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Adjuvant Breast Cancer

  • Diagnosis of HER2-overexpressing breast cancer [A]
    • AND
  • One of the following:
    • Administered as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
      • OR
    • Administered as part of a treatment regimen with docetaxel and carboplatin
      • OR
    • Administered as a single agent following multi-modality anthracycline based therapy
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin Hylecta

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Breast Cancer

  • Diagnosis of HER2-overexpressing breast cancer [A]
    • AND
  • Disease is metastatic
    • AND
  • One of the following:
    • Administered in combination with paclitaxel for first-line treatment
      • OR
    • Administered as a single agent for treatment in patients who have received one or more chemotherapy regimens for metastatic disease
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin Hylecta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Breast Cancer

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin, Hercessi, Herzuma, Ogivri, Ontruzant

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Adjuvant or Neoadjuvant Breast Cancer

  • Diagnosis of HER2-overexpressing of breast cancer [A]
    • AND
  • One of the following treatment regimens: [4, C]
    • Adjuvant treatment
    • Used in combination with Perjeta (pertuzumab)
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herzuma, Ogivri, Ontruzant

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Adjuvant or Neoadjuvant Breast Cancer

  • Diagnosis of HER2-overexpressing of breast cancer [A]
    • AND
  • One of the following treatment regimens: [4, C]
    • Adjuvant treatment
    • Used in combination with Perjeta (pertuzumab)
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen, defined as no more than a 45-day gap in therapy
Herceptin, Hercessi, Herzuma, Ogivri, Ontruzant

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Breast Cancer

  • Diagnosis of HER2-overexpressing of breast cancer [A]
    • AND
  • Disease is metastatic
    • AND
  • One of the following treatment regimens: [1, 4-6, 8-9, C]
    • Used in combination with a taxane
    • Used as a single agent in a patient who has received one or more chemotherapy regimens for metastatic disease
    • Used in combination with Perjeta (pertuzumab)
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin, Hercessi, Herzuma, Ogivri, Ontruzant

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Breast Cancer

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herzuma, Ogivri, Ontruzant

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Breast Cancer

  • Diagnosis of HER2-overexpressing of breast cancer [A]
    • AND
  • Disease is metastatic
    • AND
  • One of the following treatment regimens: [1, 4-6, 8-9, C]
    • Used in combination with a taxane
    • Used as a single agent in a patient who has received one or more chemotherapy regimens for metastatic disease
    • Used in combination with Perjeta (pertuzumab)
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen, defined as no more than a 45-day gap in therapy
Herceptin, Hercessi, Herzuma, Ogivri, Ontruzant

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Gastric Cancer

  • Diagnosis of HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma (locally advanced, recurrent, or metastatic) [1, 4-6, 8-9, A-C]
    • AND
  • Used in combination with one of the following treatment regimens: [1, 4-6, 8-9, C]
    • Platinol (cisplatin) and Adrucil (5-fluorouracil)
    • Platinol (cisplatin) and Xeloda (capecitabine)
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin, Hercessi, Herzuma, Ogivri, Ontruzantt

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Gastric Cancer

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herzuma, Ogivri, Ontruzant

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Gastric Cancer

  • Diagnosis of HER2-overexpressing gastric or gastroesophageal junction adenocarcinoma (locally advanced, recurrent, or metastatic) [1, 4-6, 8-9, A-C]
    • AND
  • Used in combination with one of the following treatment regimens: [1, 4-6, 8-9, C]
    • Platinol (cisplatin) and Adrucil (5-fluorouracil)
    • Platinol (cisplatin) and Xeloda (capecitabine)
    AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to both of the following:
      • Kanjinti
      • Trazimera
      OR
    • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen, defined as no more than a 45-day gap in therapy

  • Guideline ID
    GL-163300

  • Formulary
    premium

  • Effective date
    Mar 1, 2025

  • P&T approval date
    Sep 8, 2000

P & T Revisions

2025-01-21, 2024-05-17, 2023-06-22, 2023-06-12, 2022-06-16, 2021-12-01, 2021-08-02, 2021-06-15, 2021-04-14, 2020-05-22, 2020-04-28, 2020-03-05, 2019-11-18, 2019-08-02

  1. Herceptin Prescribing Information. Genentech, Inc. South San Francisco, CA. February 2021.
  2. Herceptin Hylecta Prescribing Information. Genentech, Inc. South San Francisco, CA. February 2019.
  3. Kanjinti Prescribing Information. Amgen Inc. Thousand Oaks, CA. October 2019.
  4. The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available at www.nccn.org. Accessed May 15, 2023.
  5. U.S. Food and Drug Administration (FDA). Biosimilar and Interchangeable Products. Silver Spring, MD: FDA; October 23, 2017. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#biosimilar. Accessed May 14, 2021.
  6. Ogivri Prescribing Information. Mylan Institutional LLC. Rockford, IL. February 2021.
  7. Trazimera Prescribing Information. Pfizer Laboratories Div Pfizer Inc. New York, NY. November 2020.
  8. Herzuma Prescribing Information. Celltrion, Inc. Incheon, Republic of Korea. May 2019.
  9. Ontruzant Prescribing Information. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. March 2020.
  10. Hercessi Prescribing Information. Accord BioPharma Inc.Raleigh, NC. September 2024.
  1. Detection of HER2 protein overexpression is necessary for selection of patients appropriate for trastuzumab therapy because these are the only patients studied and for whom benefit has been shown. Due to differences in tumor histopathology, use FDA-approved tests for the specific tumor type (e.g. breast or gastric/gastroesophageal adenocarcinoma) to assess HER2 protein overexpression and HER2 gene amplification. Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with demonstrated proficiency. Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results. Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers. Study 7 demonstrated that gene amplification and protein overexpression were not as well correlated as with breast cancer. Treatment outcomes for metastatic gastric cancer (Study 7) are based on HER2 gene amplification (FISH) and HER 2 protein overexpression (IHC) test results. [1-3, 6-9]
  2. Herceptin, Kanjinti, Ogivri, Trazimera, Herzuma and Ontruzant are indicated for the treatment of HER-2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. A pivotal study included patients previously untreated for metastatic gastric or gastroesophageal junction adenocarcinoma. [1, 3, 6-9]
  3. The FDA defines biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. [5]
  • 2025-01-21: Addition of Hercessi, a biosimilar for Herceptin mirroring criteria for Herceptin.
  • 2024-05-17: 2024 annual review. No changes.
  • 2023-06-22: Removed Oncology specialist requirement
  • 2023-06-12: Annual review - updated references.
  • 2022-06-16: Annual review - updated references.
  • 2021-12-01: Added NF sections for Herzuma, Ogivri, and Ontruzant.
  • 2021-08-02: Annual review - updated references.
  • 2021-06-15: Annual review - updated references.
  • 2021-04-14: Add new Trazimera 150mg strength to guideline. Updated GPIs due to GPI replication.
  • 2020-05-22: Annual review - no changes to clinical criteria. Updated references.
  • 2020-04-28: Added new products Herzuma and Ontruzant. Removed reference to drug name from Herceptin Hylecta reauth criteria. Updated background and references.
  • 2020-03-05: Added embedded ST for Herceptin, Herceptin Hylecta and Ogivri. Added new product Trazimera. Updated background and references.
  • 2019-11-18: Added new strength for Kanjinti. Added biosimilar Ogivri. Updated background and references.
  • 2019-08-02: Added biosimilar Kanjinti and renamed guideline to "Trastuzumab". Kanjinti criteria mirrors Herceptin. Updated references and endnotes. XC 8/1/19.