15054-0043-XX - Onivyde 43 MG/10ML INJ (IPSEN BIOPHARMACEUTICALS)
Irinotecan liposome injection is an antineoplastic agent that is formulated of the topoisomerase 1 inhibitor irinotecan hydrochloride (HCl) encapsulated in a lipid bilayer vesicle or liposome. Topoisomerase 1 is an enzyme which relieves torsional strain in DNA by inducing reversible single strand breaks. By inhibiting this repair, irinotecan induces double-strand DNA damage, breakage and eventual cell death.
With the addition of the lipid bilayer vesicle, the irinotecan remains in circulation for a longer time. Dosages of the highly toxic chemotherapeutic agent can be reduced from that of irinotecan HCl with similar intratumoral exposure.
Irinotecan liposome injection for the treatment of adenocarcinoma of the pancreas is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Irinotecan liposome injection for the treatment of other conditions/diseases is considered investigational.
Irinotecan liposome injection is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individual does not have bowel obstruction
Individual has not previously received conventional irinotecan therapy
Diagnosis of adenocarcinoma of the pancreas and ALL of the following:
Disease is locally advanced, unresectable or metastatic
Treatment is in combination with fluorouracil and leucovorin
Progression shown after treatment with ANY ONE of the following:
Fluoropyrimidine (5-FU or capecitabine) based therapy
Irinotecan liposome injection considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Tumor response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug such as severe diarrhea, severe neutropenia, pulmonary toxicity (interstitial lung disease), severe hypersensitivity reactions, etc.
DOSAGE & ADMINISTRATION
70 mg/m² intravenously every 14 daysNote: Individuals homozygous for UGT1A1*28: 50 mg/m² every 14 days
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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, the express terms of the health plan will govern.
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).
No controlled studies were found in the published literature that validate the use of irinotecan liposome for injection for the treatment of other conditions or diseases.
Lexi-Comp Online. (2018, February). AHFS DI. Irinotecan liposome. Retrieved July18, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, May). Irinotecan liposome. Retrieved July 18, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Irinotecan liposome injection. Retrieved July 18, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2015, October). Center for Drug Evaluation and Research. Onivyde™(irinotecan liposome injection), for intravenous use. Retrieved March 8, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf.
ORIGINAL EFFECTIVE DATE: 11/10/2015
MOST RECENT REVIEW DATE: 9/11/2018
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 1 mg