|59676-0610-XX Yondelis 1 MG SOLR (JANSSEN PRODUCTS)|
Trabectedin is a chemotherapeutic agent classified as an alkylating agent. It binds guanine residues in DNA causing the DNA helix to bend. This triggers a cascade of events affecting the activity of some DNA binding proteins, transcription factors and DNA repair pathways. The eventual results are disruption of the cell cycle and eventual cell death.
Trabectedin for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Liposarcoma & Leiomyosarcoma (including uterine leiomyosarcoma)
Soft Tissue Sarcoma
Trabectedin for the treatment of other conditions/diseases is considered investigational.
Trabectedin is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individual’s left ventricular ejection fraction (LVEF) is within normal limits
Treatment is as a single agent therapy
Diagnosis of ANY ONE of the following:
Liposarcoma/Leiomyosarcoma (including uterine leiomyosarcoma) if ALL of the following:
Unresectable, metastatic or recurrent disease
Used as subsequent therapy after an anthracycline-containing regimen (e.g., doxorubicin, etc)
Other soft tissue sarcomas (STS) further diagnosed as ANY ONE of the following sub-types of STS for palliative therapy only:
Retroperitoneal/intra-abdominal soft tissue sarcoma that is unresectable or progressive
Soft tissue sarcoma of the extremity/superficial trunk/head/neck that is used for metastatic disease or recurrent disease with disseminated metastases
Trabectedin is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
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 cardiomyopathy, rhabdomyolysis, hepatotoxicity and/or severe hepatic impairment, capillary leak syndrome (CPS), severe neutropenia/neutropenic sepsis, etc.
Left ventricular ejection fraction (LVEF) has not had an absolute decrease from baseline ≥ 10% and is not below the lower limit of normal (LLN) and the patient does not have symptomatic LVEF changes.
DOSAGE & ADMINISTRATION
1.5 mg/m² administered intravenously (IV) over 24 hours through a central venous line every 21 days (0.9 mg/m² in patients with moderate hepatic impairment)
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed.
Refer to DOSAGE LIMITS below
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.
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).
Lexi-Comp Online. (2018, February). AHFS DI. Trabectedin. Retrieved February 5, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, January). Trabectedin. Retrieved February 5, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®.Trabectedin. Retrieved February 5, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2018, December). Center for Drug Evaluation and Research. Product Information. Yondelis® (trabectedin). Retrieved February 5, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207953s003lbl.pdf.
ORIGINAL EFFECTIVE DATE: 11/10/2015
MOST RECENT REVIEW DATE: 3/12/2019
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