Irinotecan Liposome Injection (Onivyde®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indication
1. Onivyde, is indicated, in combination with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma.
2. Onivyde is indicated, in combination with fluorouracil and leucovorin, for the treatment of adultpatients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.
Limitation of Use: Onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas.
B. Compendial Uses
1. Locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas
2. Ampullary Adenocarcinoma
3. Hepatobiliary Cancers
a. Intrahepatic Cholangiocarcinoma
b. Extrahepatic Cholangiocarcinoma
c. Gallbladder Cancer
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
Adenocarcinoma of the Pancreas
1. Authorization of 12 months may be granted for the first-line therapy or as induction therapy followed by chemoradiation for locally advanced or metastatic pancreatic adenocarcinoma when used in combination with oxaliplatin, fluorouracil, and leucovorin.
2. Authorization of 12 months may be granted for treatment of locally advanced, recurrent, or metastatic adenocarcinoma of the pancreas when used in combination with fluorouracil and leucovorin.
Ampullary Adenocarcinoma
Authorization of 12 months may be granted for subsequent treatment of ampullary adenocarcinoma when used in combination with fluorouracil and leucovorin.
Hepatobiliary Cancers
Authorization of 12 months may be granted for subsequent treatment of unresectable or resected gross residual (R2), or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer when used in combination with fluorouracil and leucovorin.
III. CONTINUATION OF THERAPY
All members (including new members) requesting authorization for continuation of therapy must be currently receiving therapy with the requested agent.
Authorization for 12 months may be granted when all of the following criteria are met:
1. The member is currently receiving therapy with Onivyde
2. Onivyde is being used to treat an indication enumerated in Section II
3. The member is receiving benefit from therapy. Benefit is defined as:
i. No evidence of unacceptable toxicity while on the current regimen AND
ii. No evidence of disease progression while on the current regimen
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Onivyde [package insert]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc; February 2024.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed February 22, 2024.
ORIGINAL EFFECTIVE DATE: 11/10/2015
MOST RECENT REVIEW DATE: 8/30/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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