CurrentEmblemHealthPolicy MG.MM.PH.179

Yondelis (trabectedin) Intravenous

Medical coverage criteria for use of Yondelis (trabectedin) for soft tissue sarcomas including liposarcoma and leiomyosarcoma, describing initial authorization, renewal, dosing, coding, and exclusions for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyYondelis (trabectedin) Intravenous

Policy CodePolicy MG.MM.PH.179

Change TypeRevised initial criteria, tumor subtype list, and renewal LVEF threshold

Effective Date

Next Review Date

Key ActionObtain prior authorization; submit clinical evidence that the member meets policy criteria for a 6‑month authorization.

SourceLink

POLICY UPDATE CHANGES

Under liposarcoma and leiomyosarcoma, 'unresectable' was replaced with 'advanced, inoperable'.

Removed the phrase 'single agent' from the statement regarding use with an anthracycline-containing regimen.

Soft tissue sarcoma list updated to remove angiosarcoma and add solitary fibrous tumors.

Renewal criterion for acceptable LVEF change updated from '10%' to '15%'.

Removed prior age and concurrent therapy exclusions such as 'Member must be 18 years of age or older' and 'Concurrent use with DTIC (dacarbazine) or other chemotherapy'.

6 monthsLength of authorization per approval

40 unitsMaximum billable units per 21 days

1.1-1.5 mg/m2

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Dose range per administration

J9352Applicable HCPCS / J-code

59676-0610-XXListed NDC

Coverage Criteria for Yondelis (trabectedin)

Prior Authorization

Provider Actions — Documentation and Use Restrictions

Prior authorization required. Failure to submit supporting clinical evidence (documentation of prior anthracycline-containing regimen and evidence of disease progression) may result in denial.

Provider must document prior therapies and objective evidence of disease progression before authorization.
Use is restricted to administration via a central venous line; include planned route in request.

Dosing and Regimens

Regimen	Route / Administration	Dose	Frequency / Duration	Coverage
Trabectedin (Yondelis)
IV via central venous line (central line)
1.1–1.5 mg/m2
Over 24 hours, every 21 days until disease progression
Covered with criteria (see policy for indication and prior anthracycline requirement)

Coding: Procedure, NDC, and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J9352

Injection, trabectedin, 0.1 mgz 1 billable unit = 1 mg

Applicable NDCsNDCCovered

59676-0610-XX

Yondelis 1 mg vial for injection

Applicable ICD-10 Diagnoses (selection from list)ICD-10

C49.9	Malignant neoplasm of connective and soft tissue, unspecified
C48.0	Malignant neoplasm of retroperitoneum
C54.9	Malignant neoplasm of corpus uteri, unspecified
C78.01	Secondary malignant neoplasm of right lung

Dose per administration — 1.1-1.5 mg/m2 IV over 24 hours every 21 days

Dose per administration1.1-1.5 mg/m2 IV via central venous line administered over 24 hours every 21 days

Route of administrationIntravenous (IV) via central venous line over 24 hours

FrequencyEvery 21 days (repeat until disease progression)

Dose unitsmg per square meter (mg/m2)

Maximum single doseDo not exceed 1.5 mg/m2 per administration (see exclusions)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization required; 6-month authorization length

Prior authorization is required for Yondelis (J9352). Coverage is granted for 6 months and may be renewed per the policy's renewal criteria.

Submit PA request including clinical documentation (see documentation block)
Authorization length: 6 months; renewals subject to renewal criteria

Step Therapy

Prior anthracycline-containing regimen required

For liposarcoma and leiomyosarcoma, the policy requires prior exposure to an anthracycline-containing regimen with documented disease progression before Yondelis is considered.

Document prior anthracycline-containing regimen and evidence of progression on that regimen

Background on Yondelis (trabectedin)

Trabectedin (Yondelis) is an alkylating‑class anticancer agent used intravenously for advanced soft tissue sarcomas. Its clinical use is limited by specific safety and administration requirements, including central venous infusion and a maximum single dose of 1.5 mg/m2, and it is contraindicated in patients with significant chronic liver disease or certain serious cardiac conditions. Coverage is guided by accepted compendia and peer‑reviewed literature.

Definitions and Mechanism

Mechanism of action

Primary mechanismAlkylation by binding guanine residues in the minor groove of DNA, forming adducts and bending the DNA helix

Downstream effectsAlters activity of DNA-binding proteins and transcription factors

Cellular consequencesDisruption of DNA repair pathways and cell cycle leading to cell death

Therapeutic contextMechanism supports use in targeting tumor cells in advanced soft tissue sarcomas

Policy Revision History

2025-01-02annual_review - materialLatest

Initial criteria for liposarcoma and leiomyosarcoma updated: 'unresectable' replaced with 'advanced, inoperable', phrase 'single agent' removed from anthracycline progression statement; soft tissue sarcoma list updated to remove angiosarcoma and add solitary fibrous tumors; several prior limitations/exclusions deleted; renewal LVEF absolute decrease threshold changed to 15%.

2024-01-02annual_review - non-material

Annual review with no criteria changes reported.

2023-03-06

Policy Summary

PayerEmblemHealth

PolicyYondelis (trabectedin) Intravenous

Policy CodePolicy MG.MM.PH.179

Change TypeRevised initial criteria, tumor subtype list, and renewal LVEF threshold

Effective Date

Next Review Date

Key ActionObtain prior authorization; submit clinical evidence that the member meets policy criteria for a 6‑month authorization.

SourceLink

On This Page

Documentation Required

Treating physician must submit clinical evidence

The treating physician must submit clinical evidence that the member meets the policy criteria when requesting preauthorization or for post-payment review.

Include relevant oncology records, prior therapy details, and tumor status supporting the requested indication

Denial Risk

Risk of denial if clinical evidence not submitted

Failure to submit required clinical evidence will prevent proper preauthorization review or post-payment review and may result in denial.

Incomplete documentation may lead to non-approval or claim denial

Denial Risk

Provider alert: exclusion triggers that may cause non‑coverage

Use after progression on the same regimen, significant uncontrolled chronic liver disease, non-central line administration, symptomatic CHF or life‑threatening arrhythmias, or dosing >1.5 mg/m2 are listed triggers for non-coverage.

Do not administer via peripheral line—policy requires central venous line
Do not bill/seek coverage if dosing exceeds 1.5 mg/m2
Document absence of significant chronic liver disease and serious cardiac conditions

annual_review - material

Under Soft Tissue Sarcoma initial criteria, removed the word 'palliative' from the phrase related to single-agent therapy.

2023-01-19administrative

Policy content transferred to a new template.

2020-04-29revision - limitations

Limitations/Exclusions updated to add an age requirement (Member must be 18 years of age).