Zinbryta
Drug - Zinbryta™ (daclizumab) [AbbVie]
January 2017
Therapeutic Area - Multiple Sclerosis
Initial approval criteria
- Patient is 18 years of age or older AND
- Has relapsing forms of multiple sclerosis (MS) AND
- Has had inadequate response to daily Copaxone AND one other drug indicated for MS AND
- Prescriber must provide documentation of baseline ALT and AST and bilirubin levels prior to initiation of Zinbryta
- Prescriber must provide confirmation that ALT and AST and bilirubin levels will be obtained monthly prior to the next dose of Zinbryta and for 6 months after the last dose of Zinbryta
- Prescriber must provide documentation of negative tuberculosis, hepatitis B, hepatitis C screening prior to initiation of Zinbryta
- Prescriber must provide confirmation that all components of Zinbryta REMS Program have been met
- Initial approval will be for 6 months
Renewal approval criteria
- Chart notes must be supplied at time of request showing patient is responsive to treatment
- Renewal approval will be for 12 months
Denial criteria
- Patient history of autoimmune hepatitis or other autoimmune conditions involving the liver
- Patient history of hepatic disease or hepatic impairment including ALT and AST > 2 times ULN
Quantity limit
One single-dose prefilled syringe per 30 days
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
