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
- Treatment of unresectable or metastatic liposarcoma or leiomyosarcoma for individuals who received a prior anthracycline-containing regimen; or
National Comprehensive Cancer Network (NCCN) Indications
- Single-agent palliative therapy for soft tissue angiosarcoma; or
- Single-agent palliative therapy for unresectable or progressive retroperitoneal/intra-abdominal soft tissue sarcoma; or
- Single-agent palliative therapy for rhabdomyosarcoma; or
- Single-agent palliative therapy for stage IV or recurrentsoft tissue sarcoma of the extremity/superficial trunk and/or head/neck with disseminated metastases; or
- Single-agent therapy for uterine leiomyosarcoma that has been treated with a prior anthracycline-containing regimen for:
- Disease that is not suitable for primary surgery; or
- A radiologically isolated vaginal/pelvic recurrence; or
- Isolated metastases; or
- Postoperative therapy for resectable isolated metastases; or
- Disseminated metastases.
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.