Trabectedin (Yondelis®) is an alkylating agent that binds guanine residues in the minor groove of DNA, resulting in a bending of the DNA helix towards the major groove. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors and DNA repair pathways, ultimately leading to disruption of the cell cycle and cell death.
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Trabectedin (Yondelis) may be considered medically necessary for ANY of the following indications:
Food and Drug Administration (FDA) Indications
National Comprehensive Cancer Network (NCCN) Indications
The use of trabectedin (Yondelis) for any other indication is considered experimental/investigational and therefore, non-covered. Scientific evidence does not support its use for any other indications.
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.