Trabectedin (Yondelis) (ARCHIVED)

Policy ID: I-169-007

Section: Injections

Effective Date: December 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-169-007

Section: Injections

Effective Date: December 01, 2019

Revised Date: October 25, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

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.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

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 the following indications:

Treatment of unresectable or metastatic liposarcoma or leiomyosarcoma for individuals who received a prior anthracycline-containing regimen; or

Compendia Sources

Trabectedin (Yondelis) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of trabectedin (Yondelis) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9352

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

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

C54.0

C54.1

C54.2

C54.3

C54.8

C54.9

C55

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-14-2019 New policy for ND

Internal Medical Policy Committee 7-22-2020 Changed J9352 to pre-certification drug

Internal Medical Policy Committee 3-17-2021

Updated NCCN recommendations and
Updated Diagnosis codes

Internal Medical Policy Committee 3-23-2022 Annual Review - no changes in criteria

Internal Medical Policy Committee 9-28-2022

Removed NCCN recommendations and
Added this statement 'Trabectedin (Yondelis) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.', and
Updated experimental/investigational statement,
Removed Diagnosis codes C22.3 and Z85.831

Internal Medical Policy Committee 9-12-2023 Annual review, no clinical content change

Internal Medical Policy Committee 9-17-2024 Effective November 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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