Ramucirumab (Cyramza®)
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Gastric Cancer: Cyramza as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine-or platinum-containing chemotherapy.
2. Non-Small Cell Lung Cancer (NSCLC):
a. Cyramza, in combination with docetaxel, is indicated for the treatment of patients with metastatic NSCLC with disease progression on or after platinum-based chemotherapy. Patients 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 Cyramza.
b. Cyramza, in combination with erlotinib, is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
3. Colorectal Cancer: Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and fluorouracil), is indicated for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
4. Hepatocellular Carcinoma: Cyramza as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.
B. Compendial Uses
1. Esophageal adenocarcinoma
2. Colorectal cancer, advanced, including anal adenocarcinoma and appendiceal adenocarcinoma
3. NSCLC, EGFR mutation positive, recurrent, advanced
4. Mesothelioma
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: EGFR mutation testing results and alpha fetoprotein (AFP) level results (where applicable).
III. CRITERIA FOR INITIAL APPROVAL
A. Gastric, Gastro-esophageal Junction (GEJ), Esophagogastric Junction (EGJ), and Esophageal Adenocarcinoma
Authorization of 12 months may be granted for treatment of gastric, gastro-esophageal junction (GEJ), esophagogastric junction (EGJ), and esophageal adenocarcinoma for members who are not surgical candidates or who have unresectable locally advanced, recurrent or metastatic disease, when used as subsequent therapy as a single agent, in combination with paclitaxel, or in combination with irinotecan with or without fluorouracil.
B. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for treatment of recurrent, advanced or metastatic NSCLC when either of the following criteria is met:
1. Used in combination with docetaxel as subsequent therapy.
2. Used in combination with erlotinib for EGFR exon 19 deletion or exon 21 (L858R) substitution mutation positive disease.
C. Colorectal Cancer (CRC)
Authorization of 12 months may be granted for treatment of advanced or metastatic colorectal cancer, including anal adenocarcinoma and appendiceal adenocarcinoma, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) or irinotecan.
D. Hepatocellular Carcinoma (HCC)
Authorization of 12 months may be granted for subsequent treatment of progressive hepatocellular carcinoma as a single agent in members who have an alpha fetoprotein (AFP) of greater than or equal to 400 ng/mL.
E. Mesothelioma
Authorization of 12 months may be granted for the subsequent treatment of pleural mesothelioma, pericardial mesothelioma, or tunica vaginalis testis mesothelioma when used in combination with gemcitabine.
IV. CONTINUATION OF THERAPY
A. NSCLC
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for NSCLC when either of the following criteria is met:
1. There is no evidence of unacceptable toxicity or disease progression while on the current regimen, or
2. Disease is T790M negative and there is no evidence of unacceptable toxicity
B. All other indications
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
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.
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).
REFERENCES
1. Cyramza [package insert]. Indianapolis, IN: Eli Lilly and Company; March 2022.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed January 3, 2024.
3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Anal Carcinoma. Version 1.2024. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Accessed January 3, 2024.
ORIGINAL EFFECTIVE DATE: 6/14/2014
MOST RECENT REVIEW DATE: 7/9/2024
ID_CHS
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