BlueCross BlueShield of Tennessee Medical Policy Manual
Trabectedin (Yondelis®)
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
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.
FDA-Approved Indication
Yondelis is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
Compendial Uses
COVERAGE CRITERIA
Soft Tissue Sarcoma
Authorization of 12 months may be granted for treatment of liposarcoma or leiomyosarcoma when all of the following criteria are met:
Authorization of 12 months may be granted when used as a single agent for the treatment of myxoid liposarcoma when any of the following are met:
Authorization of 12 months may be granted when used as single-agent palliative therapy for the treatment of one of the following:
Authorization of 12 months may be granted when used in combination with doxorubicin for the treatment of leiomyosarcoma when either of the following are met:
Uterine Sarcoma
Authorization of 12 months may be granted as a single-agent for treatment of uterine leiomyosarcoma when all of the following criteria are met:
Authorization of 12 months may be granted in combination with doxorubicin for treatment of uterine leiomyosarcoma when all of the following criteria are met:
Ovarian Cancer
Authorization of 12 months may be granted for treatment of recurrent, platinum-sensitive ovarian cancer when used in combination with pegylated liposomal doxorubicin.
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:
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
ORIGINAL EFFECTIVE DATE: 11/10/2015
MOST RECENT REVIEW DATE: 7/1/2025
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.
This document has been classified as public information