Trastuzumab - PA, NF
Indications for Prior Authorization
Herceptin (trastuzumab), 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
- One of the following:
- Trial and failure, contraindication, or intolerance to both of the following:
- Kanjinti
- Trazimera
- 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
- One of the following:
- Trial and failure, contraindication, or intolerance to both of the following:
- Kanjinti
- Trazimera
- 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
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin, 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)
- One of the following:
- Trial and failure, contraindication, or intolerance to both of the following:
- Kanjinti
- Trazimera
- 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)
- 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
- 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, 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)
- One of the following:
- Trial and failure, contraindication, or intolerance to both of the following:
- Kanjinti
- Trazimera
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin, 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
- 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)
- 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
- 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, 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)
- One of the following:
- Trial and failure, contraindication, or intolerance to both of the following:
- Kanjinti
- Trazimera
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Herceptin, Herzuma, Ogivri, Ontruzant
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
- 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)
- 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
- 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
P & T Revisions
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
References
- Herceptin Prescribing Information. Genentech, Inc. South San Francisco, CA. February 2021.
- Herceptin Hylecta Prescribing Information. Genentech, Inc. South San Francisco, CA. February 2019.
- Kanjinti Prescribing Information. Amgen Inc. Thousand Oaks, CA. October 2019.
- The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available at www.nccn.org. Accessed May 15, 2023.
- 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.
- Ogivri Prescribing Information. Mylan Institutional LLC. Rockford, IL. February 2021.
- Trazimera Prescribing Information. Pfizer Laboratories Div Pfizer Inc. New York, NY. November 2020.
- Herzuma Prescribing Information. Celltrion, Inc. Incheon, Republic of Korea. May 2019.
- Ontruzant Prescribing Information. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. March 2020.
Revision History
- 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.
HEALTHY LIVING