Criteria
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) Recommendations
Soft Tissue Sarcoma: Angiosarcoma
- Single-agent palliative therapy for soft tissue angiosarcoma; or
Soft Tissue Sarcoma: Extremity/Body Wall, Head/Neck:
- Single agent neoadjuvant/adjuvant therapy for primary tumors or local recurrence for myxoid liposarcoma given as:
- preoperative systemic therapy, with or without radiation therapy (RT), for stage III or select stage IV (any T, N1, M0) resectable disease with acceptable functional outcomes; or
- primary treatment as systemic therapy or chemoradiation for stage II, III, or select stage IV (any T, N1, M0) resectable disease with adverse functional outcomes or unresectable disease; or
- adjuvant systemic therapy in addition to RT following primary treatment of surgery for stage III or select stage IV (any T, N1, M0) resectable disease with acceptable functional outcomes; or
- adjuvant systemic therapy, to be considered postoperatively if given primary treatment with either preoperative RT or preoperative systemic therapy with RT for stage III or select stage IV (any T, N1, M0) resectable disease with acceptable functional outcomes; or
- adjuvant systemic therapy in addition to RT given postoperatively if given primary treatment with preoperative systemic therapy for stage III or select stage IV (any T, N1, M0) resectable disease with acceptable functional outcomes; or
- adjuvant systemic therapy to be considered following primary treatment with amputation/radical resection for stage II, III, or select stage IV (any T, N1, M0) resectable disease with adverse functional outcomes or unresectable primary disease; or
- adjuvant systemic therapy for resectable disease with acceptable functional outcomes following primary treatment for stage II, III, or select stage IV (any T, N1, M0) resectable disease with adverse functional outcomes or unresectable primary disease; or
- Single-agent palliative therapy as subsequent lines of therapy for stage IV or recurrent advanced/metastatic soft tissue sarcoma of the extremity/superficial trunk body wall and/or head/neck with disseminated metastases; or
Soft Tissue Sarcoma: Retroperitoneal/Intra-Abdominal
- Single-agent palliative therapy for recurrent unresectable or Stage IV retroperitoneal/intra-abdominal soft tissue sarcoma as subsequent lines of therapy; or
- Neoadjuvant/adjuvant therapy as a single agent (useful in certain circumstances) for myxoid liposarcoma as:
- preoperative systemic therapy for resectable disease (primary or recurrent); or
- postoperative systemic therapy to be considered in histologies with high risk for metastatic disease (not recommended for low-grade tumors); or
- as postoperative systemic therapy for resectable recurrent disease to be considered for histologies with high risk of metastatic disease or history of several recurrences with a high risk for local recurrences; or
Soft Tissue Sarcoma: Rhabdomyoscarcoma
- Single-agent palliative therapy for advanced/metastatic pleomorphic rhabdomyosarcoma as subsequent line of therapy; or
Soft Tissue Sarcoma: Solitary Fibrous Tumor
- Single-agent palliative therapy for the treatment of solitary fibrous tumor; or
Uterine Neoplasms: Uterine Sarcoma
- 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
- Unresectable 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.
Procedure Codes
