Bevacizumab (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)

Bevacizumab (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)

Medical Administration – intravenous

Diagnosis considered for coverage:

• Metastatic Colorectal Cancer (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)
  • Indicated for the first- or second-line treatment of patients with metastatic colorectal cancer (mCRC) in combination with intravenous fluorouracil-based chemotherapy
  • Indicated for the second-line treatment of patients with mCRC who have progressed on a first-line bevacizumab product-containing regimen in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin- based chemotherapy
  • Limitations of Use: Bevacizumab is not indicated for adjuvant treatment of colon cancer
• First-Line Non-Squamous Non-Small Cell Lung Cancer (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)
  • Indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non– squamous non–small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel
• Recurrent Glioblastoma (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)
  • Indicated for the treatment of recurrent glioblastoma (GBM) in adults
• Metastatic Renal Cell Carcinoma (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)
  • Indicated for the treatment of metastatic renal cell carcinoma (mRCC) in combination with interferon alfa
• Persistent, Recurrent, or Metastatic Cervical Cancer (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)
  • Indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer in combination with paclitaxel and cisplatin or paclitaxel and topotecan
• Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (Alymsys, Avastin, Mvasi, Vegzelma, Zirabev)
  • In combination with carboplatin and paclitaxel, followed by bevacizumab as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
  • In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated 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
  • In combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by bevacizumab as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
• Hepatocellular Carcinoma (Avastin)
  • Indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy in combination with atezolizumab

Coverage Criteria:

For all indications:

• One of the following:
  • Both of the following:
    • Requested medication is being used for a Food and Drug Administration (FDA)-approved indication
    • 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.)
      • Prescribed medication will be used at a dose which is within FDA recommendations
  • Meets the off-label administrative guideline criteria; AND
• For requests prescribed through the medical benefit: a medically appropriate reason is provided why the patient cannot use the medical group's preferred bevacizumab agent

Reauthorization Criteria:

For all indications:

• Patient does not show evidence of progressive disease while on therapy; AND
• For requests prescribed through the medical benefit: a medically appropriate reason is provided why the patient cannot use the medical group's preferred bevacizumab agent

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Dosing:

For diagnosis of metastatic colorectal cancer:

• Administered in combination with intravenous fluorouracil-based chemotherapy:
  • 5 mg/kg intravenously every 2 weeks in combination with bolus-IFL
  • 10 mg/kg intravenously every 2 weeks in combination with FOLFOX4
  • 5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy in patients who have progressed on a first-line bevacizumab product-containing regimen

For diagnosis of non–small cell lung cancer:

• 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel

For diagnosis of recurrent glioblastoma:

• 10 mg/kg intravenously every 2 weeks

For diagnosis of metastatic renal cell carcinoma:

• 10 mg/kg intravenously every 2 weeks in combination with interferon alfa

For diagnosis of cervical cancer:

• 15 mg/kg intravenously every 3 weeks in combination with paclitaxel and cisplatin or in combination with paclitaxel and topotecan

For diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer:

• Stage III or IV Disease Following Initial Surgical Resection
  • 15 mg/kg intravenously every 3 weeks in combination with carboplatin and paclitaxel for up to 6 cycles, followed by Avastin 15 mg/kg every 3 weeks as a single agent for a total of up to 22 cycles or until disease progression, whichever occurs earlier
• Recurrent Disease
  • Platinum Resistant
    • 10 mg/kg intravenously every 2 weeks in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan (every week)
    • 15 mg/kg intravenously every 3 weeks in combination with topotecan (every 3 weeks)
  • Platinum Sensitive
    • 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and paclitaxel for 6 to 8 cycles, followed by Avastin 15 mg/kg every 3 weeks as a single agent until disease progression
    • 15 mg/kg intravenously every 3 weeks, in combination with carboplatin and gemcitabine for 6 to 10 cycles, followed by Avastin 15 mg/kg every 3 weeks as a single agent until disease progression

For diagnosis of Hepatocellular Carcinoma:

• 15 mg/kg intravenously after administration of 1,200 mg of atezolizumab intravenously on the same day, every 3 weeks until disease progression or unacceptable toxicity

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Administer as an intravenous infusion
• 100 mg/4 mL (25 mg/mL) or 400 mg/16 mL (25 mg/mL) clear to opalescent, colorless to pale brown solution in a single-dose vial

Policy Updates:

• 3/1/2024 – New policy approved by WHA P&T Committee. (P&T, 02/20/2024)

References:

• Avastin Prescribing Information. Genentech Inc. South San Francisco, CA. September 2022. 
• Mvasi Prescribing Information. Amgen Inc. Thousand Oaks, CA. November 2021. 
• Zirabev Prescribing Information. Pfizer Inc. New York, NY. May 2021. 
• 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 February 21, 2023. 
• Alymsys Prescribing Information. Amneal Pharmaceuticals LLC. Bridgewater, NJ. April 2022. 
• Vegzelma Prescribing Information. Celltrion, Inc. Jersey City, NJ. February 2023.