CurrentModa Health Plan IncPolicy N/A

Trabectedin (Evdi; Yondelis) — Intravenous therapy coverage criteria

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Defines prior authorization, dosing, indications, and renewal criteria for intravenous trabectedin (Yondelis/Evdi) for members receiving care under Moda Health Plan Inc. Applies to providers requesting coverage for trabectedin infusions.

Policy Summary

PayerModa Health Plan Inc

PolicyTrabectedin (Evdi; Yondelis) — Intravenous therapy coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJul 1, 2026

Next Review DateJun 1, 2026

Key ActionObtain prior authorization; initial approval valid for 6 months and may be renewed every 6 months with required documentation including recent LVEF and evidence of clinical benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization validity

every 6 monthsrenewal prior authorization interval

1.5 mg/m2 q21dsingle-agent dosing

J9352HCPCS (Yondelis)

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CurrentModa Health Plan IncPolicy N/A

Trabectedin (Evdi; Yondelis) — Intravenous therapy coverage criteria

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Policy Summary

PayerModa Health Plan Inc

PolicyTrabectedin (Evdi; Yondelis) — Intravenous therapy coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJul 1, 2026

Next Review DateJun 1, 2026

Key ActionObtain prior authorization; initial approval valid for 6 months and may be renewed every 6 months with required documentation including recent LVEF and evidence of clinical benefit.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization validity

every 6 monthsrenewal prior authorization interval

1.5 mg/m2 q21dsingle-agent dosing

J9352HCPCS (Yondelis)

multipleICD-10 covered

Coverage Criteria for Trabectedin (Yondelis / Evdi)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Universal: Member is at least 18 years of ageage >=18

Universal: Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months)LVEF normal

Soft Tissue Sarcoma - Combination or Single-Agent Use: For leiomyosarcoma: used in combination with doxorubicin as first-line therapy for advanced, metastatic, unresectable, or recurrent disease (including extremity/body wall/head-neck or retroperitoneal/intra-abdominal R2 resection) OR used as single-agent for liposarcoma or leiomyosarcoma for unresectable or metastatic disease after an anthracycline-containing regimen

Liposarcoma-specific requirements: For liposarcoma indications, member must demonstrate inadequate response to eribulin prior to approval of trabectedin unless there is a contraindication or intolerance; additional location- and setting-specific restrictions apply (e.g., neoadjuvant/myxoid subtype, resectable retroperitoneal disease) and use may be restricted to patients with contraindication/intolerance to generic chemotherapy in some resectable scenariosprior eribulin failure unless contraindicated

See policy for detailed setting-specific requirements

Uterine Leiomyosarcoma: Member has uterine leiomyosarcoma (uLMS) with advanced, recurrent/metastatic, or inoperable disease and receives trabectedin as subsequent single-agent therapy after an anthracycline-containing regimen OR as first-line therapy in combination with doxorubicin

Renewal Therapy — Renewal approved when ALL of the following are met

Renewal approved when ALL of the following are met

Continuation criteria: Member continues to meet the universal and indication-specific criteria (excluding prerequisite therapy), AND disease response defined by stabilization of disease or decrease in tumor size or spread, AND absence of unacceptable toxicity (examples: cardiomyopathy, rhabdomyolysis, hepatotoxicity/severe hepatic impairment, capillary leak syndrome, severe neutropenia/neutropenic sepsis, extravasation causing tissue necrosis), AND LVEF has not had an absolute decrease of >= 15% from baseline OR is not below the lower limit of normal (LLN) with an absolute decrease of >= 5% (LVEF results must be within the previous 3 months)LVEF change <15% absolute OR not below LLN with absolute decrease <5%

Examples of unacceptable toxicities are illustrative, not exhaustive

Uses not listed in the indications above have inadequate data to support efficacy and are excluded from prior authorization validity. Other appropriate treatment options may include radiation therapy, surgery, traditional chemotherapy (e.g., platinum or taxane agents), compassionate use/expanded access programs, clinical trials, supportive care, and integrative or complementary therapies.

Regimen	Dose / Schedule	Indication Notes
Single-agent trabectedin	1.5 mg/m² IV every 21 days (until disease progression or unacceptable toxicity); 1.3 mg/m² IV every 21 days for myxoid liposarcoma	For soft tissue sarcoma (including liposarcoma and leiomyosarcoma) as single‑agent therapy; continue until progression or unacceptable toxicity
Trabectedin with doxorubicin (combination)	1.1 mg/m² IV every 21 days with doxorubicin for up to 6 cycles; followed by single‑agent maintenance trabectedin 1.1 mg/m² IV every 21 days	Use in leiomyosarcoma (including uterine leiomyosarcoma) as first‑line therapy in combination with doxorubicin; maintenance permitted after combination therapy

Regimen / Trial Context	Regimen Details	Clinical Context / Indication
Trabectedin monotherapy (trial and expanded access contexts)	Single‑agent trabectedin 1.5 mg/m² IV every 21 days (or 1.3 mg/m² for myxoid liposarcoma) until progression or unacceptable toxicity	Used as subsequent therapy after failure of conventional/anthracycline‑based chemotherapy in advanced liposarcoma or leiomyosarcoma; supported by phase II/expanded access and randomized studies cited in references
Doxorubicin + trabectedin (LMS‑04 and other trials)	Trabectedin 1.1 mg/m² IV every 21 days given with doxorubicin for up to 6 cycles, followed by trabectedin maintenance 1.1 mg/m² every 21 days	Evaluated as first‑line therapy for metastatic or unresectable leiomyosarcoma in randomized and single‑arm trials (see Pautier et al. Lancet Oncol. 2022 and related references)

Coding and Dosing Details

Covered HCPCS Codes (Yondelis)HCPCSCovered

J9352

Injection, trabectedin, 0.1 mg; 1 billable unit = 0.1 mg (Yondelis Only)

Covered HCPCS Codes (Evdi)HCPCSCovered

J9999

Not otherwise classified, antineoplastic drugs (Evdi Only)

NDCsNDC

59676-0610-xx	Yondelis 1 mg single-dose vial for injection
60505-6423-xx	Evdi 1 mg/20 mL solution in a single-dose vial

Covered ICD-10 CodesICD-10Covered

C47.0	Malignant neoplasm of peripheral nerves of head, face and neck
C47.10	Malignant neoplasm of peripheral nerves of unspecified upper limb, including shoulder
C47.11	Malignant neoplasm of peripheral nerves of right upper limb, including shoulder
C47.12	Malignant neoplasm of peripheral nerves of left upper limb, including shoulder
C47.20	Malignant neoplasm of peripheral nerves of unspecified lower limb, including hip
C47.21	Malignant neoplasm of peripheral nerves of right lower limb, including hip
C47.22	Malignant neoplasm of peripheral nerves of left lower limb, including hip
C47.3	Malignant neoplasm of peripheral nerves of thorax
C47.4	Malignant neoplasm of peripheral nerves of abdomen
C47.5	Malignant neoplasm of peripheral nerves of pelvis

1–10 of 40

1/4

Medicare Part B covered diagnosis codesmixed

No codes listed

inv-09: Dosing limits (per protocol)

Single‑agent typical dose (soft tissue sarcoma)1.5 mg/m2 IV every 21 days until disease progression or unacceptable toxicity

Single‑agent dose for myxoid liposarcoma1.3 mg/m2 IV every 21 days until disease progression or unacceptable toxicity

With doxorubicin (leiomyosarcoma first‑line) — combination induction1.1 mg/m2 IV every 21 days with doxorubicin for up to 6 cycles

Maintenance after combination with doxorubicinContinue single‑agent trabectedin 1.1 mg/m2 IV every 21 days until progression or unacceptable toxicity

General unit/dosing referencePolicy lists regimen using 40 billable units every 21 days (4 mg every 21 days) as dosing reference

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Require prior authorization; 6‑month initial and renewal validity

Prior authorization is required for trabectedin (Yondelis/Evdi). Initial authorization is valid for 6 months (180 days) and may be renewed every 6 months (180 days). Member must be at least 18 years of age and meet the indication-specific criteria in the policy.

Note

PA considered per NQTL assessment (cost flagged)

Prior authorization is used for this drug group based on the plan's NQTL assessment; cost of the drug was a factor identified as 'Yes: Consider for PA' in the NQTL checklist.

Step Therapy

Document prior eribulin failure or contraindication before approval

Line of Therapy Specifications

first-line | second-line

Line of therapy options: Used as first-line in combination with doxorubicin for leiomyosarcoma; OR used as subsequent therapy after an anthracycline-containing regimen for liposarcoma or uterine leiomyosarcoma; single-agent maintenance after combination with doxorubicin permitted

Dose and cycle limits described in dosage/administration section

Background and Supporting References

Trabectedin (Yondelis; Evdi) is an antineoplastic agent indicated for select soft tissue sarcomas and uterine leiomyosarcoma. It is used as single-agent therapy for certain unresectable or metastatic leiomyosarcoma and liposarcoma after prior anthracycline-containing therapy, and may be used in combination with doxorubicin as first-line therapy for advanced or metastatic leiomyosarcoma per indication-specific criteria and supporting clinical trial data and compendia guidance.

Dosing regimens vary by indication and context: typical single-agent dosing is 1.5 mg/m2 IV every 21 days (with 1.3 mg/m2 noted for myxoid liposarcoma), and when given with doxorubicin the regimen is typically 1.1 mg/m2 IV every 21 days with doxorubicin for up to 6 cycles followed by maintenance trabectedin as described in dosing guidance.

Clinical use is informed by manufacturer prescribing information and NCCN compendia/guidelines; patients should meet baseline safety requirements (for example, adequate left ventricular ejection fraction and performance status) and monitoring protocols are required during therapy.

inv-22: NCCN Compendium / Guidelines

NCCN Drugs & Biologics Compendium (trabectedin)Referenced as a supporting compendium for clinical use of trabectedin; policy cites NCCN Compendium 2026

NCCN Clinical Practice Guidelines — Soft Tissue Sarcoma (Version 3.2026)Cited as guideline support for indications and regimen choices (accessed June 2026)

Policy Summary

PayerModa Health Plan Inc

PolicyTrabectedin (Evdi; Yondelis) — Intravenous therapy coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewJul 1, 2026

Next Review DateJun 1, 2026

Key ActionObtain prior authorization; initial approval valid for 6 months and may be renewed every 6 months with required documentation including recent LVEF and evidence of clinical benefit.

SourceLink

On This Page

inv-10: Covered Diagnosis Codes list

Soft tissue and connective/nerve neoplasms (examples)C47.x, C48.x, C49.x (malignant neoplasms of peripheral nerves, retroperitoneum/peritoneum, connective & soft tissue)

Uterine neoplasmsC54.x, C55 (malignant neoplasms of corpus uteri and uterus, part unspecified)

Neoplasm of uncertain behaviorD48.1 (neoplasm of uncertain behavior of connective and other soft tissue)

Personal history codesZ85.42 (personal history of malignant neoplasm of other parts of uterus); Z85.831 (personal history of malignant neoplasm of soft tissue)

Appendix referenceFull list of covered ICD‑10 codes enumerated in Appendix 1 of the policy (pages include C47.*, C48.*, C49.*, C54.*, C55, D48.1, Z85.*)

For many liposarcoma indications, the member must demonstrate an inadequate response to eribulin prior to approval of trabectedin unless there is a documented contraindication or intolerance; in certain neoadjuvant/resectable or other specified scenarios trabectedin is restricted to patients with a contraindication or intolerance to generic chemotherapy.

Inadequate response to eribulin must be documented unless eribulin is contraindicated or not tolerated.
Use for neoadjuvant, resectable, or retroperitoneal scenarios limited to patients with contraindication/intolerance to generic chemotherapy.

Note

UM methods (PA / other NQTLs) applied comparably across benefits

Utilization management methods such as prior authorization and other NQTLs may be applied; the plan states the utilization management NQTL applies comparably across benefits (medical and MH/SUD).

Documentation Required

Provide recent LVEF and disease response for renewal

For renewal of prior authorization, LVEF results must be available within the previous 3 months; renewal also requires documentation of disease response (stabilization or decrease in tumor size/spread) and absence of unacceptable toxicity.

LVEF must not have an absolute decrease ≥15% from baseline or be below LLN with an absolute decrease ≥5% (LVEF test within prior 3 months).
Documented disease response (stabilization or decrease) and absence of listed unacceptable toxicities are required.

Documentation Required

Follow Medicare NCDs/LCDs/LCAs where applicable

When treating Medicare members, comply with any applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs); the policy references CMS resources for applicable determinations.

Use the CMS Medicare Coverage Database to identify applicable NCDs/LCDs/LCAs.

Denial Risk

Exclude uses not listed in policy indications

Uses not listed in the policy indications lack adequate data to support efficacy and are excluded from prior authorization validity; alternative options may be appropriate (e.g., radiation, surgery, traditional chemotherapy, clinical trials).

Requests for indications not specified in the policy are excluded from PA validity.

Denial Risk

PA applied due to drug cost per NQTL checklist

Prior authorization consideration for this drug group was driven in part by the identified cost of the drug in the NQTL factor checklist; expect PA requirements due to drug cost.

NQTL checklist item: 'Cost of drug, 1 = Yes: Consider for PA.'

NCCN Clinical Practice Guidelines — Uterine Neoplasms (Version 3.2026)Cited for uterine leiomyosarcoma use and regimen context

inv-23: Package insert

Yondelis package insertYondelis [package insert]. Janssen Products, LP; January 2026. Cited in policy references

Evdi package insertEvdi [package insert]. Apotex Corp.; May 2026. Cited in policy references

Policy reference listBoth package inserts are listed among the standard references supporting dosing, administration, and safety information