Irinotecan Liposomal (Onivyde)

Section: Injections
Effective Date: August 01, 2019
Revised Date: July 23, 2019

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.

Food and Drug Administration (FDA) Indications

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.

National Comprehensive Cancer Network (NCCN) Indications

Irinotecan liposomal (Onivyde) may be considered medically necessary for pancreatic adenocarcinoma as ANY of the following:

  • Second-line therapy in combination with fluorouracil and leucovorin for locally advanced or metastatic disease in individuals with good performance status (ECOG PS 0-2) and disease progression who were previously treated with:
    • Fluoropyrimidine-based therapy and no prior irinotecan; or
    • Gemcitabine-based therapy; or
  • Therapy with (if not previously done) or without chemoradiation in combination with fluorouracil and leucovorin for local recurrence in the pancreatic operative bed after resection or metastatic disease with or without local recurrence if ≥ 6 months from completion of primary therapy in patients with good performance status (ECOG PS 0-2); or
  • Therapy for metastatic disease with or without local recurrence if less than 6 months from completion of primary therapy in individuals with good performance status (ECOG PS 0-2):
    • In combination with fluorouracil and leucovorin if previously treated with gemcitabine-based therapy; or
    • In combination with fluorouracil and leucovorin if previously treated with fluoropyrimidine-based therapy that did not include irinotecan.

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.

Procedure Codes

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. 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.

Diagnosis Codes

C25.0 C25.1 C25.2 C25.3 C25.4 C25.7 C25.8 C25.9 Z85.07

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