Irinotecan Liposomal (Onivyde)

Policy ID: I-161-006

Section: Injections

Effective Date: August 01, 2019

Revised Date: May 17, 2023

Revision Effective Date: July 01, 2023

Last Reviewed: May 23, 2023

Applies To: Commercial and Medicaid Expansion

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.

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) in combination with fluorouracil and leucovorin, may be considered medically necessary for the treatment of individuals with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy; 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 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

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

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-161-005

Section: Injections

Effective Date: August 01, 2019

Revised Date: May 17, 2022

Revision Effective Date: July 01, 2022

Last Reviewed: May 24, 2022

Archived Date: June 30, 2023

Applies To: Commercial and Medicaid Expansion

Description

Criteria

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

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) 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

J9205

Diagnosis Codes

C24.1

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 Z85.07

Links

References (PDF)

Disclaimer

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