Trabectedin (Yondelis®)

We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.

POLICY

I. INDICATIONS

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

A. FDA-Approved Indication

Indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

B. Compendial Uses

1. Uterine sarcoma

2. Soft tissue sarcoma

i. Extremity/body wall, head/neck

ii. Retroperitoneal/intra-abdominal

iii. Rhabdomyosarcoma

iv. Solitary fibrous tumor

3. Ovarian cancer

II. CRITERIA FOR INITIAL APPROVAL

A. Soft Tissue Sarcoma

1. Authorization of 12 months may be granted for treatment of liposarcoma or leiomyosarcoma when all of the following criteria are met:

i. The disease is unresectable or metastatic

ii. The member has received a prior anthracycline-containing regimen

2. Authorization of 12 months may be granted when used as a single agent for the treatment of myxoid liposarcoma when any of the following are met:

i. The requested medication will be used as neoadjuvant or adjuvant therapy for retroperitoneal/intra-abdominal sarcoma

ii. The requested medication will be used as neoadjuvant, adjuvant, or primary therapy for extremity/body wall, head/neck sarcoma

3. Authorization of 12 months may be granted when used as single-agent palliative therapy for the treatment of one of the following:

i. Solitary fibrous tumor

ii. Advanced/metastatic pleomorphic rhabdomyosarcoma

iii. Extremity/body wall, head/neck sarcoma for advanced/metastatic disease with disseminated metastases

iv. Retroperitoneal/intra-abdominal sarcoma for recurrent unresectable or stage IV disease

4. Authorization of 12 months may be granted when used in combination with doxorubicin for the treatment of leiomyosarcoma when either of the following are met:

i. The requested medication will be used as first-line treatment for advanced or metastatic therapy.

ii. The requested medication will be used as alternative systemic therapy for unresectable or progressive disease.

B. Uterine Sarcoma

Authorization of 12 months may be granted as a single-agent for treatment of uterine leiomyosarcoma when all of the following criteria are met:

1. The member has been treated with a prior anthracycline-containing regimen

2. One of the following is met:

i. The member has known or suspected extrauterine disease

ii. The disease is not suitable for primary surgery

iii. The requested medication will be used as additional therapy following total hysterectomy with or without bilateral salpingo-oophorectomy

iv. The member has resectable isolated metastases and the requested medication will be used postoperatively

v. The member has unresectable isolated metastases or disseminated disease

vi. The member has radiologically isolated vaginal/pelvic recurrence

Authorization of 12 months may be granted in combination with doxorubicin for treatment of uterine leiomyosarcoma when all of the following criteria are met:

1. The member has advanced, recurrent, metastatic or inoperable disease.

2. One of the following is met:

i. The member has known or suspected extrauterine disease

ii. The disease is not suitable for primary surgery

iii. The requested medication will be used as additional therapy following total hysterectomy with or without bilateral salpingo-oophorectomy

iv. The member has resectable isolated metastases and the requested medication will be used postoperatively

v. The member has unresectable isolated metastases or disseminated disease

vi. The member has radiologically isolated vaginal/pelvic recurrence

C. Ovarian Cancer

Authorization of 12 months may be granted for treatment of recurrent, platinum-sensitive ovarian cancer when used in combination with pegylated liposomal doxorubicin.

III. CONTINUATION OF THERAPY

All members (including new members) requesting authorization for continuation of therapy must be currently receiving therapy with the requested agent.

Authorization for 12 months may be granted when all of the following criteria are met:

A. The member is currently receiving therapy with the requested medication

B. The requested medication is being used to treat an indication enumerated in Section II

C. The member is receiving benefit from therapy. Benefit is defined as:

i. No evidence of unacceptable toxicity while on the current regimen and

ii. No evidence of disease progression while on the current regimen.

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

ADDITIONAL INFORMATION

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

REFERENCES

1. Yondelis [package insert]. Horsham, PA: Janssen Products, LP; June 2020.

3. IBM Micromedex® DRUGDEX ® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at https://www.micromedexsolutions.com. Accessed: August 7, 2023. .

ORIGINAL EFFECTIVE DATE: 11/10/2015

MOST RECENT REVIEW DATE: 7/2/2024

ID_CHS

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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