Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Yondelis (trabectedin) requires prior authorization.

2)    Yondelis is used to treat Liposarcoma and Leiomyosarcoma.

3)    Yondelis is considered a specialty drug and is covered under the medical benefit.

Yondelis (trabectiedin) is considered medically necessary for patients who meet the following criteria:

1)    Diagnosis of unresectable or metastatic Liposarcoma or Leiomyosarcoma AND

2)    Have received a previous anthracycline-containing regimen.

Yondelis is considered experimental and investigational for the following indications (not an all-inclusive list):

§  Biliary tract carcinoma/cholangiocarcinoma

§  Breast cancer

§  Desmoplastic small round cell tumor

§  Fallopian tube cancer

§  Lung cancer (including non-small cell lung cancer)

§  Malignant solitary fibrous tumor

§  Melanoma

§  Meningioma

§  Mesothelioma

§  Osteosarcoma

§  Ovarian cancer

§  Pediatric sarcomas (including Ewing sarcoma, rhabdomyosarcoma, and spindle cell sarcoma)

§  Primary peritoneal cancer

§  Prostate cancer

§  Rhabdomyosarcoma

§  Small round cell sarcoma

§  Translocation-related sarcoma (including alveolar soft part sarcoma, clear cell sarcoma, endometrial stromal sarcoma, myxoid-round cell Liposarcoma, and synovial sarcoma

1)    Aetna Medical Clinical Policy Bulletin. Trabectedin (Yondelis) accessed at http://www.aetna.com/cpb/medical/data/900_999/0903.html

2)    Yondelis Product Information. Janssen Products, LP. Horsham, PA. October 2015.

3)    Clinical Pharmacology.  Accessed online 3/14/2016.

Addendum:

1)    Effective 01/01/2017: added J9352 as appropriate code for Yondelis.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD, EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.