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Trabectedin (Yondelis)

Section: Injections
Effective Date: December 01, 2019
Revised Date: November 26, 2019

Description

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.

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) 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.

Procedure Codes

J9352

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.

Diagnosis Codes

C47.0 C47.10 C47.11 C47.12 C47.20 C47.21 C47.22
C47.3 C47.4 C47.5 C47.6 C47.8 C47.9 C48.0
C48.1 C48.2 C48.8 C49.0 C49.10 C49.11 C49.12
C49.20 C49.21 C49.22 C49.3 C49.4 C49.5 C49.6
C49.8 C49.9 C53.0 C54.0 C54.1 C54.2 C54.3
C54.8 C54.9 C55 C78.00 C78.01 C78.02 Z85.831

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