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 erlotinib, for first-line treatment of metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations; or
- In combination with docetaxel as treatment of individuals with metastatic NSCLC with disease progression on or after platinum-based therapy:
- Individuals with 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 adjuvant treatment in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) or irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion 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 ECOG performance score (PS) 0-2 as second-line or subsequent therapy as ANY of the following:
- In combination with paclitaxel; or
- As a single agent; or
- In combination with irinotecan with or without flourouracil; or
Gastric Cancer
- As palliative therapy for locoregional disease in individuals who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease and Karnofsky performance score of 60% or greater or performance score 0-2 as second-line or subsequent therapy as ANY of the following:
- In combination with paclitaxel; or
- As a single agent; or
- In combination with irinotecan with or without flourouracil; 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)
- As subsequent therapy in combination with docetaxel (if not already given) for recurrent, advanced, or metastatic disease in individuals with performance score 0-2; or
- As first line therapy in combination with erlotinib for sensitizing EGFR mutation-positive recurrent, advanced, or metastatic disease; or
- As continuation of therapy following disease progression on combination of erlotinib and ramucirumab for asymptomatic disease, symptomatic brain lesions, or symptomatic systemic limited metastases; or
Rectal Cancer
- As primary treatment for individuals with unresectable metachronous metastases and previously adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) 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 advanced or metastatic disease in combination with irinotecan or with FOLFIRI in individuals not previously treated with irinotecan-based therapy; or
- As adjuvant treatment in combination with FOLFIRI or irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion 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
