Bevacizumab - PA, NF
Indications for Prior Authorization
Avastin (bevacizumab)
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For diagnosis of Metastatic Colorectal Cancer (mCRC)
Indicated for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy.Bevacizumab, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is also indicated for second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line bevacizumab product-containing regimen.
Limitation of use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.
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For diagnosis of First-line Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
Indicated for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel. -
For diagnosis of Recurrent Glioblastoma
Indicated for the treatment of recurrent glioblastoma in adults. -
For diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
Indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa. -
For diagnosis of Persistent, Recurrent, or Metastatic Cervical Cancer
Indicated for the treatment of persistent, recurrent, or metastatic cervical cancer when used in combination with paclitaxel and cisplatin or paclitaxel and topotecan. -
For diagnosis of Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Indicated, in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial resection.Indicated, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
Indicated, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by bevacizumab as a single agent, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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For diagnosis of Hepatocellular Carcinoma
Indicated, in combination with atezolizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
Mvasi (bevacizumab-awwb), Zirabev (bevacizumab-bvzr), Alymsys (bevacizumab-maly), Vegzelma (bevacizumab-adcd)
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For diagnosis of Metastatic Colorectal Cancer (mCRC)
Indicated for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil-based chemotherapy.Bevacizumab, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is also indicated for second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line bevacizumab product-containing regimen.
Limitation of use: Bevacizumab is not indicated for adjuvant treatment of colon cancer.
-
For diagnosis of First-line Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
Indicated for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer in combination with carboplatin and paclitaxel. -
For diagnosis of Recurrent Glioblastoma
Indicated for the treatment of recurrent glioblastoma in adults. -
For diagnosis of Metastatic Renal Cell Carcinoma (mRCC)
Indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa. -
For diagnosis of Persistent, Recurrent, or Metastatic Cervical Cancer
Indicated for the treatment of persistent, recurrent, or metastatic cervical cancer when used in combination with paclitaxel and cisplatin or paclitaxel and topotecan. -
For diagnosis of Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Indicated, in combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial resection.Indicated, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.
Indicated, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by bevacizumab as a single agent, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
-
For diagnosis of Hepatocellular Carcinoma
Indicated, in combination with atezolizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. [4, A]
Criteria
Avastin, Mvasi, Zirabev, Alymsys, Vegzelma
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- One of the following:
- Both of the following:
- Requested medication is being used for a Food and Drug Administration (FDA)-approved indication AND
- Both of the following labeling requirements have been confirmed:
- All components of the FDA approved indication are met (e.g., concomitant use, previous therapy requirements, age limitations, testing requirements, etc.) AND
- Prescribed medication will be used at a dose which is within FDA recommendations
- Meets the off-label administrative guideline criteria
- One of the following (applies to Avastin, Alymsys and Vegzelma only):
- Trial and failure, or intolerance to both of the following:
- Mvasi
- Zirabev
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Avastin, Mvasi, Zirabev, Alymsys, Vegzelma
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient does not show evidence of progressive disease while on therapy AND
- One of the following (applies to Avastin, Alymsys and Vegzelma only):
- Trial and failure, or intolerance to both of the following:
- Mvasi
- Zirabev
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
Alymsys, Vegzelma
Non Formulary
Length of Approval: 12 Month(s)
- One of the following:
- Both of the following:
- Requested medication is being used for a Food and Drug Administration (FDA)-approved indication AND
- Both of the following labeling requirements have been confirmed:
- All components of the FDA approved indication are met (e.g., concomitant use, previous therapy requirements, age limitations, testing requirements, etc.) AND
- Prescribed medication will be used at a dose which is within FDA recommendations
- Meets the off-label administrative guideline criteria
- One of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, or intolerance to both of the following:
- Mvasi
- Zirabev
- Continuation of therapy for patients currently in the midst of an ongoing prescribed treatment regimen
P & T Revisions
2024-01-30, 2023-10-02, 2023-06-14, 2023-04-03, 2023-03-17, 2023-02-28, 2022-07-21, 2022-02-03, 2022-01-06, 2021-09-27, 2021-05-20, 2021-02-03, 2020-07-29, 2020-03-04, 2020-01-29
References
- Avastin Prescribing Information. Genentech Inc. South San Francisco, CA. September 2022.
- Mvasi Prescribing Information. Amgen Inc. Thousand Oaks, CA. February 2023.
- Zirabev Prescribing Information. Pfizer Inc. New York, NY. February 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 December 4, 2023.
- Alymsys Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. April 2022.
- Vegzelma Prescribing Information. Celltrion USA, Inc. Jersey City, NJ. February 2023.
End Notes
- 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. [4]
Revision History
- 2024-01-30: Annual review: Background updates.
- 2023-10-02: Streamlining all indications into one criteria bucket and added Vegzelma to NF criteria
- 2023-06-14: Removed Oncologist specialist requirement
- 2023-04-03: Added Vegzelma to guideline
- 2023-03-17: Annual review: Updated background and GPI formatting.
- 2023-02-28: Applied drug-specific NF criteria for Alymsys and added "-PA,NF" to guideline name
- 2022-07-21: Update Guideline
- 2022-02-03: Annual review: Background updates.
- 2022-01-06: Updated background (new indication).
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
- 2021-02-03: Annual review: Background updates.
- 2020-07-29: Added criteria for new indication of hepatocellular carcinoma.
- 2020-03-04: Added formulary strategy with background updates.
- 2020-01-29: Annual review: Added Mvasi and Zirabev to guideline and changed guideline name to Bavacizumab. Updated reauthorization to remove reference to drug name. Updated background.
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