Yondelis
Drug - Yondelis® (trabectedin) [Janssen Products, LP]
January 2017
Therapeutic area - Oncology
Approval criteria
- Patient must be 18 years of age or older AND
- Have a diagnosis of unresectable or metastatic liposarcoma or leimyosarcoma AND
- Must have tried at least one prior anthrycycline-based chemotherapy regimen AND
- Female patients of reproductive potential must be advised to use effective contraception during and for 2 months after the last dose of Yondelis
- Male patients with a female sexual partner of reproductive potential must be advised to use effective contraception during and for 5 months after the last dose of Yondelis
- Documentation of diagnosis and reproductive health counseling from patient’s medical records must be provided at time of request
Quantity limit
- Dosing is based on body surface area. Maximum of 1.5 mg/m2 body surface area every 3 weeks
- Patient’s most current body surface area must be provided at time of request
Approvals
- Initial approval will be limited to 6 months in duration
- Renewal approval will be limited to 6 months in duration
- Chart notes must be supplied at time of request showing patient is responsive to treatment
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
