Ramucirumab (Cyramza)

Policy ID: I-148-006

Section: Injections

Effective Date: July 01, 2019

Revised Date: May 19, 2022

Revision Effective Date: July 01, 2022

Last Reviewed: May 24, 2022

Applies To: Commercial and Medicaid Expansion

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:

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

Compendia Sources

Ramucirumab (Cyramza) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations

The use of ramucirumab (Cyramza) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Procedure Codes

J9308

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.

Diagnosis Codes

C15.3

C15.4

C15.5

C15.8

C15.9

C16.0

C16.1

C16.2

C16.3

C16.4

C16.5

C16.6

C16.8

C16.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C22.0

C22.8

C22.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C78.00

C78.01

C78.02

C78.6

C78.7

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Added additional NCCN indications and formatting changes, updated FDA statement, added additional diagnosis

Internal Medical Policy Committee 1-19-2021 Annual review, no clinical content change

Internal Medical Policy Committee 7-22-2021 Added additional FDA indication and NCCN recommendations, removed five diagnosis codes

Internal Medical Policy Committee 5-24-2022 Removed NCCN recommendations and added this statement "Ramucirumab (Cyramza) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.", removed diagnosis codes (C17.0, C17.1, C17.2, C17.8, C17.9, D37.1, D37.8, D37.9, Z85.00, Z85.01, Z85.028, Z85.038, Z85.068), updated the experimental/investigational statement

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-148-005

Section: Injections

Effective Date: July 01, 2019

Revised Date: June 21, 2021

Revision Effective Date: September 01, 2021

Last Reviewed: July 22, 2021

Archived Date: June 30, 2022

Applies To: Commercial and Medicaid Expansion

Description

Criteria

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

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

J9308

Diagnosis Codes

C15.3

C15.4

C15.5

C15.8

C15.9

C16.0

C16.1

C16.2

C16.3

C16.4

C16.5

C16.6

C16.8

C16.9

C17.0

C17.1

C17.2

C17.8

C17.9

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C22.0

C22.8

C22.9

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C78.00

C78.01

C78.02

C78.6

C78.7

D37.1

D37.8

D37.9

Z85.00

Z85.01

Z85.028

Z85.038

Z85.068

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Added additional NCCN indications and formatting changes, updated FDA statement, added additional diagnosis

Internal Medical Policy Committee 1-19-2021 Annual review, no clinical content change

Internal Medical Policy Committee 7-22-2021 Added additional FDA indication and NCCN recommendations, removed five diagnosis codes

Links

References (PDF)

Disclaimer

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