CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Yondelis (trabectedin) — coverage criteria for soft tissue and uterine sarcoma

Defines accepted indications, exclusions, coding, and authorization expectations for use of Yondelis (trabectedin) in treating certain soft tissue and uterine sarcomas for Neighborhood Health Plan of Rhode Island members and other applicable lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyYondelis (trabectedin) — coverage criteria for soft tissue and uterine sarcoma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and support the request with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or qualifying peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9352HCPCS code for trabectedin (0.1 mg)

1.5 mg/m2single dose maximum

Commercial, Exchange, Medicaidapplicable lines of business

FDA + compendia/guidelinesevidence sources required

Coverage Criteria for Yondelis (trabectedin)

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Soft tissue sarcoma — covered indications

Covered when ALL of the following are met for specified soft tissue sarcomas:

Soft tissue sarcoma indication: Member has unresectable or metastatic soft tissue sarcoma of leiomyosarcoma, liposarcoma, or translocation-related sarcoma histology

Yondelis may be used as monotherapy or in combination with doxorubicin as first-line or subsequent therapy

Uterine leiomyosarcoma — covered indication

Covered when ALL of the following are met for uterine sarcoma:

Uterine leiomyosarcoma indication: Member has unresectable or metastatic uterine leiomyosarcoma

Yondelis used as single agent for members with disease progression after prior anthracycline-based chemotherapy unless contraindicated/intolerant to anthracyclines

Use of Yondelis (trabectedin) is limited to specific soft tissue sarcoma histologies. Supported histologies are leiomyosarcoma, liposarcoma, and translocation‑related sarcomas in the setting of unresectable or metastatic disease. Use for other soft tissue sarcoma histologies is not supported by this policy; the position reflects available trial evidence (including the T‑SAR trial) that did not demonstrate clinically meaningful benefit for other translocation‑related sarcoma populations and directs clinicians to alternative agents/regimens where appropriate.

Dosing that exceeds a single dose limit of 1.5 mg/m2 is excluded from coverage. Requests with planned or administered single doses greater than this threshold will be denied per the policy’s exclusion criteria.

Evidence of disease progression while on Yondelis (trabectedin) is a basis for non‑coverage. Continuation requests must document absence of progression; if progression on therapy is documented, further treatment with Yondelis is considered not medically necessary and will be denied.

Permitted Regimens and Indications

Regimen	Indication	Line(s) of therapy	Coverage status
Trabectedin (Yondelis) as monotherapy	Unresectable or metastatic soft tissue sarcoma of leiomyosarcoma, liposarcoma, or translocation‑related histology	First‑line or subsequent therapy	Covered when all criteria are met
Trabectedin (Yondelis) in combination with doxorubicin	Unresectable or metastatic soft tissue sarcoma of leiomyosarcoma, liposarcoma, or translocation‑related histology	First‑line or subsequent therapy	Covered when all criteria are met

Regimen	Indication	Required prior therapy	Coverage status
Trabectedin (Yondelis) as single agent	Unresectable or metastatic uterine leiomyosarcoma	Disease progression after prior anthracycline‑based chemotherapy (unless contraindicated/intolerant)	Covered when all criteria are met

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required; use must be supported by acceptable evidence sources. Continuation requests may be exempt when criteria below are met.

Prior authorization required for Yondelis (trabectedin) requests
Acceptable evidence sources: FDA labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature meeting CMS standards

Documentation Required

Required Supporting Documentation

Use must be supported by documentation from one of the following sources: FDA approved product labeling; CMS‑recognized compendia; NCCN or ASCO clinical guidelines; or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.

Provide supporting citations or excerpts from the applicable source (labeling, compendia, guideline, or peer‑reviewed article)
If relying on peer‑reviewed literature, include full article and justify how study population, regimen, and outcomes are applicable to the member
Document dosing and regimen and confirm single dose does not exceed 1.5 mg/m2

Documentation Required

Continuation Request Documentation

For continuation requests, provide documentation demonstrating ongoing benefit and prior authorized use without lapse.

Evidence member has not experienced disease progression while on the requested medication
Proof prior authorization was active within the last year with no gap >30 days between authorization end and requested renewal
No additional medications added to the continuation request

Denial Risk

Triggers for Denial

Requests may be denied if exclusion criteria are met or supporting evidence is insufficient.

Disease progression while on Yondelis (trabectedin)
Dosing exceeds single dose limit of 1.5 mg/m2
Investigational use or off‑label indications lacking sufficient evidence or not supported by CMS compendia/guidance
Use for soft tissue sarcoma histologies other than leiomyosarcoma, liposarcoma, or translocation‑related sarcomas is not supported
Use for indications not adequately represented in the published evidence (insufficient population/regimen/outcomes)
Abstracts, case reports, or uncontrolled anecdotal evidence alone are insufficient

Key Definitions

inv-14: Translocationadrelated sarcomas adad— definition and inclusion among supported histologies

DefinitionSoft tissue sarcoma subgroup characterized by specific chromosomal translocations (translocation‑related sarcomas)

Covered histology groupIncluded among the supported soft tissue sarcoma histologies for trabectedin alongside leiomyosarcoma and liposarcoma

Policy noteYondelis may be used as monotherapy or with doxorubicin for leiomyosarcoma, liposarcoma, and translocation‑related sarcomas; other soft tissue sarcoma histologies are not supported

Background on Trabectedin (Yondelis)

Trabectedin (Yondelis) is an antineoplastic agent indicated for certain soft tissue sarcomas and for uterine leiomyosarcoma under specified circumstances. This policy permits use in members with unresectable or metastatic leiomyosarcoma, liposarcoma, or translocation‑related sarcomas, either as monotherapy or combined with doxorubicin for first‑line or subsequent therapy. For uterine leiomyosarcoma, trabectedin is supported as a single agent after disease progression on anthracycline‑based chemotherapy. The policy also defines exclusions: off‑label or investigational uses lacking sufficient evidence, dosing above the 1.5 mg/m2 single‑dose limit, and continued therapy in the setting of documented disease progression are not covered.