Description

Ramucirumab (Cyramza®) is a recombinant human IgG1 monoclonal antibody that blocks the binding of vascular endothelial growth factor (VEGF) receptor 2 to VEGFR ligands (VEGF-A, VEGF-C, and VEGF-D). By attaching itself to the VEGF receptor 2 of cancer cells, ramucirumab (Cyramza) is able to prevent the receptor from being activated, thus inhibiting proliferation and migration of the cells, and inhibiting angiogenesis.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Ramucirumab (Cyramza) may be considered medically necessary for ANY of the following indications:

Food and Drug Administration (FDA) Indications

Colorectal Cancer

• In combination with irinotecan, folinic acid, and fluorouracil (FOLFIRI) for the treatment of individuals with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine; or

Gastric Cancer

• As a single agent or in combination with paclitaxel for individuals with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy; or

Hepatocellular Carcinoma

• As single agent therapy for the treatment of individuals with HCC who have an alpha fetoprotein (AFP) of 400 ng/mL or greater and have been treated with sorafenib; or

Lung Cancer, Non-Small Cell (NSCLC)

• In combination with docetaxel as treatment of individuals with metastatic NSCLC with disease progression on or after platinum-based therapy:
  • Individuals with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab (Cyramza); or

National Comprehensive Cancer Network (NCCN) Recommendations

Colon Cancer

• As subsequent therapy for progression of unresectable advanced or metastatic disease in combination with irinotecan or with FOLFIRI regimen in individuals not previously treated with irinotecan-based therapy; or
• As primary treatment for unresectable metachronous metastases and previous adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) within the past 12 months as ANY of the following:
  • In combination with irinotecan; or
  • In combination with FOLFIRI; or

Esophageal and Esophagogastric Junction Cancers

• As palliative therapy for individuals who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic adenocarcinoma and Karnofsky performance score of 60% or greater or performance status (PS) 0-2 as second-line or subsequent therapy as ANY of the following:
  • In combination with paclitaxel; or
  • As a single agent; or

Gastric Cancer

• As palliative therapy for locoregional disease in individuals who are not surgical candidates, recurrent, or metastatic disease and Karnofsky performance score of 60% of greater or PS 0-2 as second-line or subsequent therapy as ANY of the following:
  • In combination with paclitaxel; or
  • As a single agent; or

Hepatocellular Carcinoma

• As single agent subsequent treatment for progressive disease in individuals with AFP 400 ng/mL or higher in ANY of the following:
  • Have unresectable disease and are not a transplant candidate; or
  • Are inoperable by performance status or comorbidity, or have local disease or local disease with minimal extrahepatic disease only; or
  • Have metastatic disease or extensive liver tumor burden; or

Lung Cancer, Non-Small Cell (NSCLC)

• In combination with docetaxel (if not already given) for recurrent, advanced, or metastatic disease in individuals with PS 0-2; or

Rectal Cancer

• As primary treatment for individuals with unresectable metachronous metastases and previously adjuvant FOLFOX or CapeOX within the past 12 months for ANY of the following:
  • In combination with irinotecan; or
  • In combination with FOLFIRI; or
• As subsequent therapy for progression of unresectable advanced or metastatic disease in combination with irinotecan or with FOLFIRI in individuals not previously treated with irinotecan-based therapy.

Ramucirumab (Cyramza) is considered experimental/investigational for all other indications. Scientific evidence does not support the use of ramucirumab (Cyramza) for any other indications not listed above.

Procedure Codes

Note: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

NA

ND Committee Review Internal Medical Policy Committee

1-22-2020 added additional NCCN indications and formatting changes, updated FDA statement, added additional diagnosis, updated references [this info is also for Ramucirumab (Cyramza)]