Ziv-aflibercept (Zaltrap)

Policy ID: I-112-009

Section: Injections

Effective Date: August 01, 2019

Revised Date: November 07, 2022

Revision Effective Date: January 01, 2023

Last Reviewed: November 15, 2023

Applies To: Commercial and Medicaid Expansion

Description

Ziv-aflibercept (Zaltrap) is a recombinant fusion protein, which acts as a soluble receptor that binds to vascular endothelial growth factor-A (VEGF-A), vascular endothelial growth factor-B (VEGF-B) and placental growth factor (PIGF). Ziv-aflibercept (Zaltrap) is designed to act as a VEGF trap to prevent activation of VEGF receptors and thus inhibit angiogenesis. Inhibition of these factors can result in decreased neo-vascularization and decreased vascular permeability.

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.

Ziv-aflibercept (Zaltrap) may be considered medically necessary for the treatment of metastatic colorectal cancer (mCRC) when the following are met:

In combination with FOLFIRI (5-fluorouracil, leucovorin, and irinotecan) for the treatment of individuals with mCRC who are resistant to or has progressed following an oxaliplatin-containing regimen; or

Compendia Sources

Ziv-aflibercept (Zaltrap) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of ziv-aflibercept (Zaltrap) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9400

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. 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

C18.0

C18.1

C18.2

C18.3

C18.4

C18.5

C18.6

C18.7

C18.8

C18.9

C19

C20

C21.8

C78.6

C78.7

C78.00

C78.01

C78.02

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-16-2019 Adopted policy

Internal Medical Policy Committee 7-22-2020 Coding update

Added one additional diagnosis code to policy, Z85.068

Internal Medical Policy Committee 7-22-2021 Annual review, no clinical content change

Internal Medical Policy Committee 9-21-2021 Added additional NCCN recommendation

Internal Medical Policy Committee 9-28-2022 Annual Review-no changes in criteria

Internal Medical Policy Committee 11-29-2022

Removed NCCN recommendations; and
Added this statement 'Ziv-aflibercept (Zaltrap) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'; and
Updated experimental/investigational statement; and
Removed diagnosis codes C17.0, C17.1, C17.2, C17.8, C17.9, Z85.038 and Z85.068

Internal Medical Policy Committee 11-15-2023 Annual review, no clinical content change

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-112-007

Section: Injections

Effective Date: August 01, 2019

Revised Date: September 07, 2021

Revision Effective Date: November 01, 2021

Last Reviewed: September 28, 2022

Archived Date: December 31, 2022

Applies To: Commercial and Medicaid Expansion

Description

Ziv-aflibercept (Zaltrap) is a recombinant fusion protein, which acts as a soluble receptor that binds to vascular endothelial growth factor-A (VEGF-A), vascular endothelial growth factor-B (VEGF-B) and placental growth factor (PIGF). Ziv-aflibercept (Ziltrap) is designed to act as a VEGF trap to prevent activation of VEGF receptors and thus inhibit angiogenesis. Inhibition of these factors can result in decreased neo-vascularization and decreased vascular permeability.

Criteria

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

Ziv-aflibercept (Ziltrap) may be considered medically necessary for the treatment of ANY of the following conditions:

Food and Drug Administration (FDA) Indication

Colorectal Cancer

Treatment for metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen, in combinations with FOLFIRI (5-fluorouracil, leucovorin, and irinotecan); or

National Comprehensive Cancer Network (NCCN) Recommendations

Colon or Rectal Cancer - Adenocarcinoma

Primary treatment for individuals with unresectable metachronous metastases and previous adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) within the past 12 months in combination with:
- Irinotecan; or
- FOLFIRI regimen; or
Adjuvant treatment in combination with FOLFIRI or irinotecan for unresectable metachronous metastases that converted to resectable disease after primary treatment; or
Subsequent therapy for progression of advanced or metastatic disease in combination with irinotecan or FOLFIRI regimen not previously treated with irinotecan-based regimens.

Ziv-aflibercept (Ziltrap) is considered experimental/investigational for all other indications and therefore non-covered. Scientific evidence does not support its use for any other indications.

Procedure Codes