BlueCross BlueShield of Tennessee Medical Policy Manual

Trabectedin

NDC CODE(S)

59676-0610-XX Yondelis 1 MG SOLR (JANSSEN PRODUCTS)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All Indications

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)

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 trabectedin for the treatment of conditions or diseases.

SOURCES

Lexi-Comp Online. (2017, March). AHFS DI. Trabectedin. Retrieved May 23, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, April). Trabectedin. Retrieved May 23, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®.Trabectedin. Retrieved May 23, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, May). Center for Drug Evaluation and Research. Product Information. Yondelis® (trabectedin). Retrieved May 23, 2017 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207953s003lbl.pdf.  

ORIGINAL EFFECTIVE DATE:  11/10/2015

MOST RECENT REVIEW DATE:  8/11/2017

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

Trabectedin (Yondelis ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #9

  1. Is the individual 18 years of age or older and having left ventricular ejection fraction (LVEF) within normal limits?

If yes, go to question #3

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

  1. Will treatment be as a single agent?

If yes, go to question #4

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

  1. Does the individual have a diagnosis of a soft tissue sarcoma diagnosed as Liposarcoma /Leiomyosarcoma (including uterine leiomyosarcoma) that is ALL of the following?

If yes, go to question #6

If no, go to question #5

  1. Does the individual have a diagnosis of a soft tissue sarcoma further diagnosed as ANY ONE of the following for palliative therapy only?

If yes, go to question #6

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

  1. Is the request for 40 billable units every 21 days for dosage of 1.5 mg/m²  (0.9 mg/m² in patients with moderate hepatic impairment) administered intravenously (IV) over 24 hours through a central venous line every 21 days for an authorization period of three months with possible renewal?

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 6?

If yes, go to question #8

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

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

If yes, go to question #9

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 cardiomyopathy, rhabdomyolysis, nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, headache, neutropenia, hepatotoxicity and/or severe hepatic impairment, thrombocytopenia, and anemia?

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.