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.
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.
Irinotecan liposomal (Onivyde) may be considered medically necessary for pancreatic adenocarcinoma as ANY of the following:
The use of irinotecan liposomal (Onivyde) for all other indications is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of irinotecan liposomal (Onivyde) for any other indications.
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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.