Irinotecan Liposomal (Onivyde) (ARCHIVED)

Policy ID: I-161-008

Section: Injections

Effective Date: August 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-161-008

Section: Injections

Effective Date: August 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Irinotecan liposomal (Onivyde^®) is a topoisomerase 1 inhibitor encapsulated in a lipid bilayer vesicle or liposome. Topoisomerase 1 relieves torsional strain in DNA by inducing single-strand breaks. Irinotecan and its active metabolite bind reversibly to the topoisomerase 1-DNA complex and prevent re-ligation of the single-strand breaks, leading to exposure time-dependent double-strand DNA damage and cell death.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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.

Irinotecan liposomal (Onivyde) may be considered medically necessary for ONE or more of the following conditions:

Pancreatic Cancer

In combination with fluorouracil and leucovorin for the treatment of adult individuals with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy; or
In combination with oxaliplatin, fluorouracil and leucovorin for the first line treatment of adult individuals with metastatic pancreatic adenocarcinoma; or

Compendia Sources

Irinotecan liposomal (Onivyde) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of irinotecan liposomal (Onivyde) 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

J9205

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

C22.1

C23

C24.0

C24.1

C24.8

C24.9

C25.0

C25.1

C25.2

C25.3

C25.7

C25.8

C25.9

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 Annual review, no clinical content change

Internal Medical Policy Committee 11-19-2020

Removed diagnosis code C25.4 from policy

Internal Medical Policy Committee 11-23-2021 Annual review, no clinical content change

Internal Medical Policy Committee 5-24-2022

Removed NCCN recommendations and
Added this statement 'Irinotecan liposomal (Onivyde) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.',
Updated the experimental/investigational statement,
Added dx code C24.1 and
Removed dx code Z85.07

Internal Medical Policy Committee 5-23-2023 - Effective July 1, 2023

Added diagnosis codes C22.1, C23, C24.0, C24.8, and C24.9
Updated E/I statement

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Updated criteria

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

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.

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