Trabectedin (Yondelis) (CPB 0903, reviewed 2026-01-13)

By January 13, 2026: Billing team must update prior authorization protocols and claim validation rules in billing system to enforce Trabectedin (Yondelis) coverage criteria. (1) For uterine sarcoma (C54.0-C54.9, C55, C57.4): Require documentation showing advanced/recurrent/metastatic/inoperable leiomyosarcoma AND either first-line combination with doxorubicin OR second-line+ monotherapy. (2) For soft tissue sarcoma (C49.0-C49.9): Verify diagnosis specificity (extremity/body wall/head-neck vs. retroperitoneal/intra-abdominal) and treatment line (subsequent lines for palliative, first-line combination for unresectable leiomyosarcoma, primary/neoadjuvant/adjuvant for myxoid liposarcoma). (3) For other approved indications (pleomorphic rhabdomyosarcoma, solitary fibrous tumor, dedifferentiated liposarcoma C49.x, epithelioid hemangioendothelioma D18.01): Confirm monotherapy status and palliative/adjuvant indication. (4) REJECT claims for experimental indications (breast, lung, pancreatic, ovarian, cervical, colorectal, bone sarcomas, leukemia, lymphoma, mesothelioma, etc.). (5) Flag combination therapy with irinotecan for desmoplastic round cell tumor as experimental. (6) For CPT 96413-96416 (chemotherapy administration) and J9352 (trabectedin), J9000/Q2049/Q2050 (doxorubicin): Cross-reference diagnosis codes and line of therapy before approval. Providers must include in authorization request: specific sarcoma subtype, stage/metastatic status, prior treatments, and combination agent (if applicable). Claims submitted without supporting documentation or for non-approved indications will be denied. Billing team to implement system edits requiring ICD-10 diagnosis matching to approved list before claim submission.