BlueCross BlueShield of Tennessee Medical Policy Manual

Ramucirumab

NDC CODE(S)

00002-7669-XX Cyramza 100 MG/10ML SOLN (LILLY)

 

00002-7678-XX Cyramza 500 MG/50ML SOLN (LILLY)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Gastric, gastroesophageal, and colorectal cancer

8 mg/kg every 2 weeks

NSCLC

10 mg/kg every 21 days

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

No controlled studies were found in the published literature that validate the use of ramucirumab for the treatment or prevention of any other condition or disease.

SOURCES

Lexicomp Online. (2017, March). AHFS DI. Ramucirumab. Retrieved May 12, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, March). Ramucirumab. Retrieved May 12, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Ramucirumab. Retrieved May 12, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, April). Center for Drug Evaluation and Research. Cyramza® (ramucirumab) injection for intravenous infusion. Retrieved May 12, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125477s011lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/14/2014

MOST RECENT REVIEW DATE:  8/11/2017

ID_MRx

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.

Pharmaceutical Decision Support Tree

Ramucirumab (Cyramza®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #8

  1. Is the individual 18 years of age of older?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of metastatic colorectal cancer if ALL of the following?

If yes, go to question #7

If no, go to question #4

  1. Does the individual have a diagnosis of ANY ONE of the following?

If yes, go to question #5

If no, go to question #6

  1. Does the individual meet ALL of the following?

If yes, go to question #7

If no, go to question #6

  1. Does the individual have a diagnosis of non-small cell lung cancer with ALL of the following?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following for an authorization period of 6 months with possible renewal?

INDICATION(S)

BILLABLE UNITS

DOSAGE & ADMINISTRATION

Gastric, gastroesophageal, and colorectal cancer

900mg every 14 days

180 billable units every 14 days

8 mg/kg every 2 weeks

NSCLC

1200 mg every 21 days

240 billable units every 21 days

10 mg/kg every 21 days

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 3 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug such as hemorrhage, arterial thrombotic events, uncontrollable hypertension, severe proteinuria (> 3g/24h), gastrointestinal perforation and/or hematologic toxicity (neutropenia, thrombocytopenia)?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.