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.
Procedure Codes
