00002-7669-XX Cyramza 100 MG/10ML SOLN (LILLY)
00002-7678-XX Cyramza 500 MG/50ML SOLN (LILLY)
Ramucirumab is a recombinant human IgG1 monoclonal antibody. As a vascular endothelial growth factor (VEGF) receptor 2 antagonist, ramucirumab binds specifically to VEGF receptor 2 or VEGFR2 This blocks the growth factor ligands VEGF-A, VEGF-C and VEGF-D from binding to the receptor which prevents ligand-stimulated activation of VEGFR2. This inhibits ligand-induced proliferation and migration of endothelial cells to inhibit angiogenesis and supplying increased blood flow to tumors. In this way ramucirumab prevents the growth of blood vessels necessary for tumor growth.
Ramucirumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Colorectal Cancer (adenocarcinoma)
Esophageal Cancer (adenocarcinoma)
Esophagogastric junction cancer/Gastro-esophageal junction (adenocarcinoma)
Gastric cancer (adenocarcinoma)
Hepatocellular Carcinoma (HCC)
Non-small cell lung cancer (NSCLC) (adenocarcinoma with mixed subtypes, squamous cell carcinoma, large cell carcinoma)
Ramucirumab for the treatment of other conditions/diseases is considered investigational.
Ramucirumab is considered medically appropriate if the individual is 18 years of age or older and ANY ONE of the following criteria are met:
Colorectal Cancer (adenocarcinoma) if ANY ONE of the following:
Used in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) for metastatic disease that progressed on or after therapy with bevacizumab, oxaliplatin and a fluoropyrimidine
Used in combination with irinotecan or irinotecan-based regimen (e.g., FOLFIRI) and ANY ONE of the following:
Used as first-line therapy for metastatic disease after adjuvant therapy with FOLFOX (fluorouracil, folinic acid, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within previous 12 months
Used as subsequent therapy after first progression for unresectable advanced or metastatic disease and individual has not been previously treated with irinotecan-based therapy
Gastric, Esophageal and Gastro-esophageal Junction Cancers (adenocarcinomas) and ALL of the following:
Individual has unresectable advanced, recurrent or metastatic disease
Used as a single agent OR in combination with paclitaxel
Must be used as second-line or subsequent therapy
Hepatocellular Carcinoma (HCC) and ALL of the following:
Used as single agent therapy for adenocarcinoma
Used as subsequent therapy for progressive disease
Individual has an alfa-fetoprotein (AFP) level of ≥ 400 ng/mL with ANY ONE of the following:
Unresectable disease and not a transplant candidate
Not a surgical candidate based on performance status or comorbidity, or has local disease or local disease with minimal extrahepatic disease only
Metastatic disease or extensive liver tumor burden
Non-Small Cell Lung Cancer (NSCLC) if ALL of the following:
Disease is recurrent, advanced or metastatic
Used as subsequent therapy following progression on a first-line cytotoxic regimen
Must be used in combination with docetaxel
Individual has not previously been treated with docetaxel or ramucirumab
Ramucirumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug such as hemorrhage, arterial thrombotic events, uncontrolled hypertension, infusion-related reactions, severe proteinuria (> 3g/24h)/nephrotic syndrome, gastrointestinal perforation, wound healing complications, reversible posterior leukoencephalopathy syndrome (RPLS), thyroid dysfunction, etc.
DOSAGE & ADMINISTRATION
Gastric, gastroesophageal, hepatocellular carcinoma and colorectal cancer
8 mg/kg every 14 days
10 mg/kg every 21 days
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed.
Refer to DOSAGE LIMITS below
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Lexicomp Online. (2019, February). AHFS DI. Ramucirumab. Retrieved March 14, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, November). Ramucirumab. Retrieved March 14, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Ramucirumab. Retrieved March 14, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, August). Center for Drug Evaluation and Research. Cyramza® (ramucirumab) injection for intravenous infusion. Retrieved March 14, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125477s030lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/14/2014
MOST RECENT REVIEW DATE: 7/31/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 5 mg