BlueCross BlueShield of Tennessee Medical Policy Manual

Irinotecan Liposome Injection

NDC CODE(S)

69171-0398-XX - Onivyde 43 MG/10ML INJ (IPSEN BIOPHARMACEUTICALS)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Pancreatic Cancer

70 mg/m² every 14 days

Note: Individuals homozygous for UGT1A1*28: 50 mg/m² every 14 days

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.

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, the express terms of the health plan will govern.

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).

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.

SOURCES

Lexi-Comp Online. (2017, August). AHFS DI. Irinotecan liposome. Retrieved September 7, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, August). Irinotecan liposome. Retrieved September 7, 2017 from MICROMEDEX Healthcare Series.  

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Irinotecan liposome injection. Retrieved September 7, 2017 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 September 7, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf.

ORIGINAL EFFECTIVE DATE:  11/10/2015

MOST RECENT REVIEW DATE:  11/14/2017

ID_MRx

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.

Pharmaceutical Decision Support Tree

Irinotecan Liposome Injection (Onivyde ™)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Is the individual ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show progression after treatment with gemcitabine-based therapy or Fluoropyrimidine (5-FU or capecitabine) based therapy without prior irinotecan?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Will treatment be in combination with fluorouracil and leucovorin?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 172 billable units per 14 days for dosage of 70 mg/m2 every 14 days (unless homozygous for UGT1A1*28, then 50 mg/m² every 14 days) for an authorization period of 6 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 5?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is tumor response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug such as severe diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis, pyrexia, lymphopenia, severe neutropenia, pulmonary toxicity (interstitial lung disease), etc.?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.